Rheumatoid Arthritis
Conditions
Brief summary
Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
Interventions
DRUGAbatacept
Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
DRUGMethotrexate
Tablets, Oral, \>= 15 mg, weekly, 1 year
DRUGPlacebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA. * Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 | Day 169 | ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. |
| Mean BL Liver Function Parameters in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 | Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 | BL (Day 0), Day 365 | To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value |
| Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Day 365 to Day 2,185 | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. |
| Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Day 365 to Day 2,185 | Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL. |
| Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | Day 365 to Day 2,185 | Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL. |
| Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Day 365 to Day 2,185 | Sodium \< 0.9 \* LLN or \> 1.05 \* ULN or if BL \< LLN then use \< 0.95 \* BL or \> ULN or if BL \> ULN then use \>1.05 \*BL or \< LLN; Potassium: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \< 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Chloride: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \<0.9 \* BL or \>ULN or if BL \> ULN then use \> 1.1 \* BL or \< LLN; Calcium \<0.8 \* LLN or \> 1.2 \* ULN or if BL \< LLN then use \<0.67 \* BL or \> ULN or if BL \> ULN then use \> 1.3 \* BL or \< LLN. |
| Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | Day 365 to Day 2,185 | Glucose: \< 65 mg/dL or \> 220 mg/dL; Fasting Glucose: \<0.8 \* LLN or \> 1.5 \* ULN or if BL \< LLN then use \< 0.8 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Total protein: \< 0.9 \* LLN or 1.1 \* ULN or if BL \< LLN then use 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Albumin: \< 0.9 \* LLN or if BL \< LLN then use 0.75 \* BL; Uric acid: \> 1.5 \* ULN or if BL \> ULN then use \> 2.0 \* BL. All urinalysis abnormalities were defined as: if missing BL then use \>= 2 or if value \>=4, or if BL = 0 or 0.5 then use \>= 2, or if BL = 1.0 then use \>= 3, or if BL = 2.0 then use \>=4. |
| Mean BL Immunoglobulins Over Time in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093 | Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093. |
| Mean Change From BL in Immunoglobulins in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093 | — |
| Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period | Day 1 to Day 1,821 | Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T. |
| Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period | Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. | Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant. |
| Number of Participants Experiencing AEs of Special Interest in the OL Period | Day 365 to Day 2,185 | AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. |
| Mean BL Hematocrit in the OL Period | Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in Participant Hematocrit in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean BL Platelet Count in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in Participant Platelet Count in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean BL White Blood Cells in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in White Blood Cells in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean Change From BL in Liver Function Parameters in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean BL Select Laboratory Parameters in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in Select Laboratory Parameters in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
| Mean BL Serum Electrolytes in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185. |
| Mean Change From BL in Serum Electrolytes in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185 | All changes in participant laboratory parameters were monitored on each day of study drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. |
| ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment. |
| ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease. |
| Number of Participants Discontinuing in the DB Period | Day 1 to Day 169, Day 170 to Day 365 | Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment. |
| Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period | BL (Day 0), Day 365 | To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL. |
| Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period | Day 1 to Day 365 | All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant. |
| Participants Experiencing AEs of Special Interest in the DB Period | Day 1 to Day 365 | AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. |
| Number of ACR 20 Responders in the DB and OL Periods | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821 | ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. |
| Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | BL (Day 0), Day 169, Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Day 169 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Number of Participants With Immunogenicity to Abatacept in the DB Period | Day 1 to Day 365 | Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T. |
| Number of New Tender Joints and Number of New Swollen Joints in the DB Period | Day 169, Day 365 | Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment. |
| Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | Day 169, Day 365 | — |
| Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Day 1 to Day 365 | Marked abnormality criteria were: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL. |
| Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | Day 1 to Day 365 | Marked abnormality criteria were: Aspartate Aminotransferase (AST) \>3 \* ULN or if BL \> ULN then use \>4 \*BL; Alanine Aminotransferase (ALT) \>3 \* ULN or if BL \> ULN then use \> 4 \* BL; Creatinine \> 1.5 \* BL. |
| Mean BL ESR and CRP Levels in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185 | Mean baseline values are reported for each cohort at each time point. |
| Mean Change From BL in ESR in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185 | Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values. |
| Participant RF Seroconversion in the OL Period | Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185 | This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL. |
| Number of ACR 70 Responders in the DB and OL Periods | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821 | ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits. |
| Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\> 5.1); low (≤ 3.2); remission (\< 2.6). |
| Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Change from baseline in participant were calculated at all study visits in the DB and OL periods. |
| Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in DAS-28 ESR Over Time in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period. |
| Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821 | Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Mean BL Fatigue in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in Fatigue in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. |
| Mean BL Sleep Quality in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29. |
| Mean Change From BL in Sleep Quality in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185 | The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29. |
| Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457 | Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457 | The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. |
| Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0), Day 169, Day 365 | Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0), Day 169, Day 365 | The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants. |
| Mean Change From BL in RF in the DB Period | BL (Day 0), Day 169, Day 365 | The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0), Day 169, Day 365 | Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0), Day 169, Day 365 | The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | BL (Day 0), Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 449 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | BL (Day 0), Day 449 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 533 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | BL (Day 0), Day 533 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Number of Tender Joints and Swollen Joints at DB BL | BL (Day 0) | — |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | BL (Day 0), Day 617 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 729 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | BL (Day 0), Day 729 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 813 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | BL (Day 0), Day 813 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 897 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | BL (Day 0), Day 897 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 981 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | BL (Day 0), Day 981 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,093 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | BL (Day 0), Day 1,093 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,177 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | BL (Day 0), Day 1,177 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,261 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | BL (Day 0), Day 1,261 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,345 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | BL (Day 0), Day 1,345 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,457 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | BL (Day 0), Day 1,457 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,625 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | BL (Day 0), Day 1,625 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,821 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | BL (Day 0), Day 1,821 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 1,989 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | BL (Day 0), Day 1,989 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 2,185 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | BL (Day 0), Day 2,185 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | BL (Day 0), Day 617 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
| Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | BL (Day 0) | Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible. |
| BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period | BL (Day 365) | This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL. |
| ACR 20 Responders at Day 365 | Day 365 | ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. |
| ACR 20 Responders in the Double-Blind (DB) Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| ACR 50 Responders at Day 169 | Day 169 | ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits. |
| ACR 50 Responders at Day 365 | Day 365 | ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| ACR 50 Responders in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits. |
| ACR 70 Responders at Day 169 | Day 169 | ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| ACR 70 Responders at Day 365 | Day 365 | ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| ACR 70 Responders in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| Number of Participants Achieving Major Clinical Response By Day 365 | Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period. | A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period. |
| Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0), Day 169, Day 365, Day 169, Day 365 | The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\>5.1); low (≤3.2); remission (\<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Day 1 to Day 365 | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. |
| Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | BL (Day 0), Day 365 | To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value. |
| Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) | BL (Day 0), Day 169, Day 365 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period | BL (Day 0), Day 169, Day 365 | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. |
| Number of ACR 50 Responders in the DB and OL Periods | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821 | ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. |
| Participants in the DB Period Achieving an Extended Major Clinical Response | Day 1 to Day 365 | An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. |
| Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0), Day 169, Day 365 | The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | BL (Day 0), Day 169, Day 365 | The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. |
| Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | BL (Day 0), Day 169, Day 365 | The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants. |
| Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | BL (Day 0), Day 169, Day 365 | The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants. |
| ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment. |
| ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. |
| ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365 | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI. |
Countries
United States
Participant flow
Recruitment details
Participants in this evaluation were enrolled 116 sites worldwide: 31 sites in the United States; 32 sites in Europe, 13 sites in Canada; 4 sites in Australia; 7 sites in Argentina; 7 sites in Brazil; 7 sites in Mexico; 3 sites in Peru; 5 sites in South Africa; 3 sites in Taiwan; and 4 sites in Turkey.
Pre-assignment details
Of 1250 participants enrolled, 594 participants were not randomized (519 no longer met study criteria, 37 for unknown reasons, 33 withdrew consent, 3 lost to follow-up, 1 administrative reason by sponsor, and 1 adverse event). Four participants (2 per group) were randomized but never treated; 2 no longer met study criteria and 2 withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| ABA + MTX DB Abatacept was dosed by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. | 433 |
| MTX + Placebo DB Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. | 219 |
| Total | 652 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind Period Days 170 to 365 | Adverse Event | 7 | 1 | 0 |
| Double-Blind Period Days 170 to 365 | Death | 1 | 1 | 0 |
| Double-Blind Period Days 170 to 365 | Lack of Efficacy | 2 | 7 | 0 |
| Double-Blind Period Days 170 to 365 | No Longer Met Study Criteria | 1 | 1 | 0 |
| Double-Blind Period Days 170 to 365 | Poor/Non-Compliance | 0 | 1 | 0 |
| Double-Blind Period Days 170 to 365 | Pregnancy | 2 | 0 | 0 |
| Double-Blind Period Days 170 to 365 | Withdrawal by Subject | 3 | 1 | 0 |
| Double-Blind Period Days 1 to 169 | Adverse Event | 11 | 3 | 0 |
| Double-Blind Period Days 1 to 169 | Lack of Efficacy | 11 | 33 | 0 |
| Double-Blind Period Days 1 to 169 | Lost to Follow-up | 1 | 1 | 0 |
| Double-Blind Period Days 1 to 169 | Unknown Reasons | 2 | 4 | 0 |
| Double-Blind Period Days 1 to 169 | Withdrawal by Subject | 7 | 4 | 0 |
| Open-Label Period | Administrative Decision By Sponsor | 0 | 0 | 1 |
| Open-Label Period | Adverse Event | 0 | 0 | 49 |
| Open-Label Period | Death | 0 | 0 | 13 |
| Open-Label Period | Lack of Efficacy | 0 | 0 | 32 |
| Open-Label Period | Lost to Follow-up | 0 | 0 | 7 |
| Open-Label Period | No Longer Met Study Criteria | 0 | 0 | 2 |
| Open-Label Period | Pregnancy | 0 | 0 | 5 |
| Open-Label Period | Unknown Reasons | 0 | 0 | 25 |
| Open-Label Period | Withdrawal by Subject | 0 | 0 | 26 |
Baseline characteristics
| Characteristic | MTX + Placebo DB | Total | ABA + MTX DB |
|---|---|---|---|
| Age Continuous | 50.4 years STANDARD_DEVIATION 12.4 | 51.1 years STANDARD_DEVIATION 12.7 | 51.5 years STANDARD_DEVIATION 12.9 |
| Duration of Rheumatoid Arthritis (RA) Disease > 10 years | 74 Participants | 209 Participants | 135 Participants |
| Duration of Rheumatoid Arthritis (RA) Disease <= 2 years | 45 Participants | 144 Participants | 99 Participants |
| Duration of Rheumatoid Arthritis (RA) Disease > 2 years to <= 5 years | 46 Participants | 139 Participants | 93 Participants |
| Duration of Rheumatoid Arthritis (RA) Disease > 5 years to <=10 years | 54 Participants | 160 Participants | 106 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 28 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 34 Participants | 23 Participants |
| Race (NIH/OMB) White | 193 Participants | 572 Participants | 379 Participants |
| Sex: Female, Male Female | 40 Participants | 136 Participants | 96 Participants |
| Sex: Female, Male Male | 179 Participants | 516 Participants | 337 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 466 / 539 | 320 / 433 | 144 / 219 |
| serious Total, serious adverse events | 215 / 539 | 68 / 433 | 27 / 219 |
Outcome results
Primary
Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value
Time frame: BL (Day 0), Day 365
Population: All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 | BL | 21.68 Units on a Scale | Standard Deviation 18.07 |
| ABA + MTX DB | Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 | Mean Change From BL | 0.63 Units on a Scale | Standard Deviation 1.77 |
| MTX + Placebo DB | Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 | BL | 21.83 Units on a Scale | Standard Deviation 18.63 |
| MTX + Placebo DB | Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 | Mean Change From BL | 1.14 Units on a Scale | Standard Deviation 2.81 |
p-value: 0.029Nonparametric ANCOVA
Primary
Mean BL Hematocrit in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 729 (n=328, 143) | 38.72 Percentage of Red Blood Cells | Standard Deviation 4.52 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 1,905 (n=134, 68) | 38.11 Percentage of Red Blood Cells | Standard Deviation 4.56 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 1,457 (n=292, 130) | 38.59 Percentage of Red Blood Cells | Standard Deviation 4.48 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 1,989 (n=121,56) | 38.07 Percentage of Red Blood Cells | Standard Deviation 4.78 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 1,093 (n=312, 138) | 38.69 Percentage of Red Blood Cells | Standard Deviation 4.57 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 2,073 (n=81,38) | 37.11 Percentage of Red Blood Cells | Standard Deviation 3.92 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 1,821 (n=262,124) | 38.70 Percentage of Red Blood Cells | Standard Deviation 4.44 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 2,185 (n=82,37) | 37.25 Percentage of Red Blood Cells | Standard Deviation 3.83 |
| ABA + MTX DB | Mean BL Hematocrit in the OL Period | Day 365 (n=365, 157) | 38.79 Percentage of Red Blood Cells | Standard Deviation 4.6 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 2,185 (n=82,37) | 39.02 Percentage of Red Blood Cells | Standard Deviation 3.45 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 365 (n=365, 157) | 39.38 Percentage of Red Blood Cells | Standard Deviation 4.32 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 729 (n=328, 143) | 39.39 Percentage of Red Blood Cells | Standard Deviation 4.19 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 1,093 (n=312, 138) | 39.46 Percentage of Red Blood Cells | Standard Deviation 4.33 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 1,457 (n=292, 130) | 39.40 Percentage of Red Blood Cells | Standard Deviation 4.27 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 1,821 (n=262,124) | 39.48 Percentage of Red Blood Cells | Standard Deviation 4.43 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 1,905 (n=134, 68) | 39.83 Percentage of Red Blood Cells | Standard Deviation 3.9 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 1,989 (n=121,56) | 39.99 Percentage of Red Blood Cells | Standard Deviation 4.12 |
| MTX + Placebo DB | Mean BL Hematocrit in the OL Period | Day 2,073 (n=81,38) | 39.12 Percentage of Red Blood Cells | Standard Deviation 3.45 |
Primary
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,457 (n=292, 130) | 7.23 g/dL | Standard Deviation 0.51 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 365 (n=365, 157) | 4.03 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,457 (n=292, 130) | 4.02 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,185 (n=82,37) | 3.97 g/dL | Standard Deviation 0.32 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,821 (n=262,124) | 12.49 g/dL | Standard Deviation 1.51 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 365 (n=365, 157) | 12.49 g/dL | Standard Deviation 1.57 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,821 (n=262,124) | 7.23 g/dL | Standard Deviation 0.49 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,093 (n=312, 138) | 7.23 g/dL | Standard Deviation 0.51 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,821 (n=262,124) | 4.02 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 365 (n=365, 157) | 7.23 g/dL | Standard Deviation 0.52 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,905 (n=134, 68) | 12.35 g/dL | Standard Deviation 1.55 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 729 (n=328, 143) | 7.22 g/dL | Standard Deviation 0.52 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,905 (n=134, 68) | 7.27 g/dL | Standard Deviation 0.52 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 729 (n=328, 143) | 12.50 g/dL | Standard Deviation 1.54 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,905 (n=134, 68) | 4.03 g/dL | Standard Deviation 0.32 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 729 (n=328, 143) | 4.01 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,989 (n=121,56) | 12.35 g/dL | Standard Deviation 1.6 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,989 (n=121,56) | 4.03 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,989 (n=121,56) | 7.25 g/dL | Standard Deviation 0.51 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,073 (n=81,38) | 12.21 g/dL | Standard Deviation 1.46 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,093 (n=312, 138) | 4.02 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,073 (n=81,38) | 7.18 g/dL | Standard Deviation 0.47 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,093 (n=312, 138) | 12.48 g/dL | Standard Deviation 1.55 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,073 (n=81,38) | 3.98 g/dL | Standard Deviation 0.33 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,457 (n=292, 130) | 12.46 g/dL | Standard Deviation 1.54 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,185 (n=82,37) | 12.25 g/dL | Standard Deviation 1.44 |
| ABA + MTX DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,185 (n=82,37) | 7.18 g/dL | Standard Deviation 0.47 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,185 (n=82,37) | 12.82 g/dL | Standard Deviation 1.19 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 365 (n=365, 157) | 7.35 g/dL | Standard Deviation 0.56 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 365 (n=365, 157) | 4.13 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 729 (n=328, 143) | 12.72 g/dL | Standard Deviation 1.49 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 729 (n=328, 143) | 4.12 g/dL | Standard Deviation 0.29 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,093 (n=312, 138) | 12.75 g/dL | Standard Deviation 1.55 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,989 (n=121,56) | 7.38 g/dL | Standard Deviation 0.55 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,989 (n=121,56) | 4.12 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,185 (n=82,37) | 7.28 g/dL | Standard Deviation 0.45 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 365 (n=365, 157) | 12.70 g/dL | Standard Deviation 1.56 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 729 (n=328, 143) | 7.34 g/dL | Standard Deviation 0.55 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,093 (n=312, 138) | 7.34 g/dL | Standard Deviation 0.55 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,093 (n=312, 138) | 4.11 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,457 (n=292, 130) | 12.74 g/dL | Standard Deviation 1.5 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,457 (n=292, 130) | 7.35 g/dL | Standard Deviation 0.57 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,457 (n=292, 130) | 4.12 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,821 (n=262,124) | 12.79 g/dL | Standard Deviation 1.57 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,821 (n=262,124) | 7.37 g/dL | Standard Deviation 0.56 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,821 (n=262,124) | 4.13 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,905 (n=134, 68) | 12.88 g/dL | Standard Deviation 1.33 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,905 (n=134, 68) | 7.35 g/dL | Standard Deviation 0.53 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,905 (n=134, 68) | 4.13 g/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,989 (n=121,56) | 12.98 g/dL | Standard Deviation 1.46 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,073 (n=81,38) | 12.84 g/dL | Standard Deviation 1.18 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,073 (n=81,38) | 7.27 g/dL | Standard Deviation 0.44 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,073 (n=81,38) | 4.08 g/dL | Standard Deviation 0.33 |
| MTX + Placebo DB | Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,185 (n=82,37) | 4.08 g/dL | Standard Deviation 0.33 |
Primary
Mean BL Immunoglobulins Over Time in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin G (IgG) Day 365 | 1278 mg / mL | Standard Deviation 412.4 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgM Day 729 | 146.2 mg / mL | Standard Deviation 87.34 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgA Day 729 | 328.0 mg / mL | Standard Deviation 133.8 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgA Day 1,093 | 321.8 mg / mL | Standard Deviation 133.4 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin M (IgM) Day 365 | 145.1 mg / mL | Standard Deviation 86.72 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgG Day 1,093 | 1273 mg / mL | Standard Deviation 392.3 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgG Day 729 | 1280 mg / mL | Standard Deviation 410.4 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | IgM Day 1,093 | 148.6 mg / mL | Standard Deviation 91.01 |
| ABA + MTX DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin A (IgA) Day 365 | 327.0 mg / mL | Standard Deviation 135.2 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgM Day 1,093 | 153.5 mg / mL | Standard Deviation 88.82 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin A (IgA) Day 365 | 319.2 mg / mL | Standard Deviation 145.1 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin G (IgG) Day 365 | 1317 mg / mL | Standard Deviation 425.4 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | Immunoglobulin M (IgM) Day 365 | 154.3 mg / mL | Standard Deviation 85.53 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgA Day 729 | 317.0 mg / mL | Standard Deviation 145 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgG Day 729 | 1315 mg / mL | Standard Deviation 425.3 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgM Day 729 | 153.1 mg / mL | Standard Deviation 85.8 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgA Day 1,093 | 318.5 mg / mL | Standard Deviation 145.7 |
| MTX + Placebo DB | Mean BL Immunoglobulins Over Time in the OL Period | IgG Day 1,093 | 1319 mg / mL | Standard Deviation 436.8 |
Primary
Mean BL Liver Function Parameters in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 365 (n=365, 157) | 99.56 U/L | Standard Deviation 37.11 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,821 (n=262,124) | 23.22 U/L | Standard Deviation 24.74 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,093 (n=312, 138) | 99.18 U/L | Standard Deviation 34.95 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,821 (n=262,124) | 21.63 U/L | Standard Deviation 12.98 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 365 (n=365, 157) | 34.89 U/L | Standard Deviation 32.59 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,821 (n=262,124) | 35.50 U/L | Standard Deviation 34.74 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,093 (n=312, 138) | 22.75 U/L | Standard Deviation 23.38 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,905 (n=134, 68) | 97.33 U/L | Standard Deviation 35.95 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,905 (n=134, 68) | 21.43 U/L | Standard Deviation 12.21 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,093 (n=312, 138) | 21.60 U/L | Standard Deviation 12.55 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,905 (n=134, 68) | 35.08 U/L | Standard Deviation 31.28 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 729 (n=328, 143) | 98.30 U/L | Standard Deviation 35.22 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,989 (n=121,56) | 97.46 U/L | Standard Deviation 35.63 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,093 (n=312, 138) | 34.34 U/L | Standard Deviation 29.93 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,989 (n=121,56) | 23.15 U/L | Standard Deviation 23.24 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 365 (n=365, 157) | 22.35 U/L | Standard Deviation 22.07 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,989 (n=121,56) | 21.55 U/L | Standard Deviation 12.72 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,457 (n=292, 130) | 100.8 U/L | Standard Deviation 36.04 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,989 (n=121,56) | 35.27 U/L | Standard Deviation 32.43 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,905 (n=134, 68) | 22.57 U/L | Standard Deviation 22.33 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,073 (n=81,38) | 86.87 U/L | Standard Deviation 30.05 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,457 (n=292, 130) | 23.05 U/L | Standard Deviation 23.95 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,073 (n=81,38) | 22.34 U/L | Standard Deviation 24.62 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 729 (n=328, 143) | 21.62 U/L | Standard Deviation 12.35 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 2,073 (n=81,38) | 20.93 U/L | Standard Deviation 12.7 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,457 (n=292, 130) | 21.88 U/L | Standard Deviation 12.84 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,073 (n=81,38) | 35.62 U/L | Standard Deviation 37.07 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 365 (n=365, 157) | 21.53 U/L | Standard Deviation 12 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,185 (n=82,37) | 87.33 U/L | Standard Deviation 30.52 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,457 (n=292, 130) | 35.80 U/L | Standard Deviation 34.83 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | 22.51 U/L | Standard Deviation 24.78 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 729 (n=328, 143) | 35.37 U/L | Standard Deviation 33.62 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | 20.80 U/L | Standard Deviation 12.29 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,821 (n=262,124) | 99.80 U/L | Standard Deviation 34.22 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,185 (n=82,37) | 36.23 U/L | Standard Deviation 37.42 |
| ABA + MTX DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 729 (n=328, 143) | 22.74 U/L | Standard Deviation 22.91 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,185 (n=82,37) | 30.46 U/L | Standard Deviation 21.69 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,905 (n=134, 68) | 92.19 U/L | Standard Deviation 35.33 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 365 (n=365, 157) | 98.73 U/L | Standard Deviation 41.23 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 365 (n=365, 157) | 23.40 U/L | Standard Deviation 27.35 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 365 (n=365, 157) | 22.87 U/L | Standard Deviation 15.14 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 365 (n=365, 157) | 30.73 U/L | Standard Deviation 26.54 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 729 (n=328, 143) | 99.49 U/L | Standard Deviation 41.24 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 729 (n=328, 143) | 23.21 U/L | Standard Deviation 28.38 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 729 (n=328, 143) | 22.87 U/L | Standard Deviation 15.5 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 729 (n=328, 143) | 28.73 U/L | Standard Deviation 19.92 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,093 (n=312, 138) | 99.43 U/L | Standard Deviation 40.8 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,093 (n=312, 138) | 23.01 U/L | Standard Deviation 28.87 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,093 (n=312, 138) | 22.91 U/L | Standard Deviation 15.69 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,093 (n=312, 138) | 28.43 U/L | Standard Deviation 20.15 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,457 (n=292, 130) | 99.75 U/L | Standard Deviation 41.9 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,457 (n=292, 130) | 23.43 U/L | Standard Deviation 29.67 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,457 (n=292, 130) | 23.29 U/L | Standard Deviation 16.08 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,457 (n=292, 130) | 28.34 U/L | Standard Deviation 20.35 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,821 (n=262,124) | 97.68 U/L | Standard Deviation 33.66 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,821 (n=262,124) | 23.55 U/L | Standard Deviation 30.34 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,821 (n=262,124) | 23.50 U/L | Standard Deviation 16.37 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,821 (n=262,124) | 27.76 U/L | Standard Deviation 19.77 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,905 (n=134, 68) | 25.65 U/L | Standard Deviation 39.19 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,905 (n=134, 68) | 24.60 U/L | Standard Deviation 20.64 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,905 (n=134, 68) | 30.01 U/L | Standard Deviation 22.38 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,989 (n=121,56) | 95.18 U/L | Standard Deviation 36.81 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,989 (n=121,56) | 27.80 U/L | Standard Deviation 42.76 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,989 (n=121,56) | 25.82 U/L | Standard Deviation 22.44 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,989 (n=121,56) | 31.39 U/L | Standard Deviation 23.44 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,073 (n=81,38) | 78.53 U/L | Standard Deviation 22.77 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,073 (n=81,38) | 27.50 U/L | Standard Deviation 50.75 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 2,073 (n=81,38) | 25.37 U/L | Standard Deviation 26.59 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,073 (n=81,38) | 30.47 U/L | Standard Deviation 21.4 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,185 (n=82,37) | 78.97 U/L | Standard Deviation 22.92 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | 27.82 U/L | Standard Deviation 51.41 |
| MTX + Placebo DB | Mean BL Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | 25.81 U/L | Standard Deviation 26.81 |
Primary
Mean BL Platelet Count in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 729 (n=328, 143) | 351.8 10^9 c/L | Standard Deviation 110.4 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 1,905 (n=134, 68) | 365.7 10^9 c/L | Standard Deviation 113.9 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 1,457 (n=292, 130) | 352.7 10^9 c/L | Standard Deviation 106.4 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 1,989 (n=121,56) | 366.1 10^9 c/L | Standard Deviation 115.3 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 1,093 (n=312, 138) | 351.7 10^9 c/L | Standard Deviation 107.9 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 2,073 (n=81,38) | 375.2 10^9 c/L | Standard Deviation 118.6 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 1,821 (n=262,124) | 351.1 10^9 c/L | Standard Deviation 98.28 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 2,185 (n=82,37) | 380.4 10^9 c/L | Standard Deviation 119.7 |
| ABA + MTX DB | Mean BL Platelet Count in the OL Period | Day 365 (n=365, 157) | 352.7 10^9 c/L | Standard Deviation 108.5 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 2,185 (n=82,37) | 320.3 10^9 c/L | Standard Deviation 91.59 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 365 (n=365, 157) | 339.2 10^9 c/L | Standard Deviation 97.92 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 729 (n=328, 143) | 334.2 10^9 c/L | Standard Deviation 91.41 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 1,093 (n=312, 138) | 334.8 10^9 c/L | Standard Deviation 96.35 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 1,457 (n=292, 130) | 335.0 10^9 c/L | Standard Deviation 98.59 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 1,821 (n=262,124) | 334.2 10^9 c/L | Standard Deviation 97.52 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 1,905 (n=134, 68) | 333.7 10^9 c/L | Standard Deviation 89.66 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 1,989 (n=121,56) | 326.6 10^9 c/L | Standard Deviation 86.82 |
| MTX + Placebo DB | Mean BL Platelet Count in the OL Period | Day 2,073 (n=81,38) | 321.2 10^9 c/L | Standard Deviation 90.51 |
Primary
Mean BL Select Laboratory Parameters in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,457 (n=292, 130) | 3.49 mg/dL | Standard Deviation 0.54 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,821 (n=262,124) | 15.93 mg/dL | Standard Deviation 5.29 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,457 (n=292, 130) | 95.81 mg/dL | Standard Deviation 28.9 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 365 (n=365, 157) | 0.74 mg/dL | Standard Deviation 0.17 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,457 (n=292, 130) | 4.73 mg/dL | Standard Deviation 1.4 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 729 (n=328, 143) | 9.26 mg/dL | Standard Deviation 0.44 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day Day 1,821 (n=262,124) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,821 (n=262,124) | 0.73 mg/dL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,185 (n=82,37) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,821 (n=262,124) | 9.25 mg/dL | Standard Deviation 0.45 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 729 (n=328, 143) | 3.50 mg/dL | Standard Deviation 0.57 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,821 (n=262,124) | 3.49 mg/dL | Standard Deviation 0.53 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 365 (n=365, 157) | 9.26 mg/dL | Standard Deviation 0.44 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,821 (n=262,124) | 96.81 mg/dL | Standard Deviation 30.21 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 729 (n=328, 143) | 97.36 mg/dL | Standard Deviation 30.59 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,821 (n=262,124) | 4.66 mg/dL | Standard Deviation 1.29 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,073 (n=81,38) | 100.4 mg/dL | Standard Deviation 31.96 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,905 (n=134, 68) | 0.43 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 729 (n=328, 143) | 4.79 mg/dL | Standard Deviation 1.41 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,905 (n=134, 68) | 16.15 mg/dL | Standard Deviation 5.74 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 365 (n=365, 157) | 3.48 mg/dL | Standard Deviation 0.57 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,905 (n=134, 68) | 0.72 mg/dL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,093 (n=312, 138) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,905 (n=134, 68) | 9.30 mg/dL | Standard Deviation 0.45 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,185 (n=82,37) | 3.58 mg/dL | Standard Deviation 0.58 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,905 (n=134, 68) | 3.50 mg/dL | Standard Deviation 0.56 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,093 (n=312, 138) | -0.36 mg/dL | Standard Deviation 0.26 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,905 (n=134, 68) | 96.82 mg/dL | Standard Deviation 31.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 365 (n=365, 157) | 96.63 mg/dL | Standard Deviation 29.3 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,905 (n=134, 68) | 4.70 mg/dL | Standard Deviation 1.25 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,093 (n=312, 138) | 0.73 mg/dL | Standard Deviation 0.17 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,989 (n=121,56) | 0.43 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,073 (n=81,38) | 3.61 mg/dL | Standard Deviation 0.58 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,989 (n=121,56) | 16.26 mg/dL | Standard Deviation 5.68 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,093 (n=312, 138) | 0.04 mg/dL | Standard Deviation 0.03 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,989 (n=121,56) | 0.71 mg/dL | Standard Deviation 0.14 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 365 (n=365, 157) | 4.80 mg/dL | Standard Deviation 1.45 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,989 (n=121,56) | 9.31 mg/dL | Standard Deviation 0.44 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,093 (n=312, 138) | 0.02 mg/dL | Standard Deviation 0.04 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,989 (n=121,56) | 3.51 mg/dL | Standard Deviation 0.57 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 365 (n=365, 157) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,989 (n=121,56) | 98.59 mg/dL | Standard Deviation 33.41 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,093 (n=312, 138) | 96.49 mg/dL | Standard Deviation 29.7 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,989 (n=121,56) | 4.72 mg/dL | Standard Deviation 1.25 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,093 (n=312, 138) | -0.15 mg/dL | Standard Deviation 0.06 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,073 (n=81,38) | 0.42 mg/dL | Standard Deviation 0.19 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 729 (n=328, 143) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 2,073 (n=81,38) | 16.36 mg/dL | Standard Deviation 5.83 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,457 (n=292, 130) | 0.42 mg/dL | Standard Deviation 0.18 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 2,073 (n=81,38) | 0.68 mg/dL | Standard Deviation 0.13 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 2,073 (n=81,38) | 4.58 mg/dL | Standard Deviation 1.19 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,073 (n=81,38) | 9.41 mg/dL | Standard Deviation 0.36 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,457 (n=292, 130) | 15.86 mg/dL | Standard Deviation 5.28 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 2,185 (n=82,37) | 16.40 mg/dL | Standard Deviation 5.86 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 729 (n=328, 143) | 16.02 mg/dL | Standard Deviation 5.23 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 2,185 (n=82,37) | 0.68 mg/dL | Standard Deviation 0.13 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,457 (n=292, 130) | 0.73 mg/dL | Standard Deviation 0.17 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,185 (n=82,37) | 9.43 mg/dL | Standard Deviation 0.41 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Blood Urea Nitrogen (BUN) Day 365 (n=365, 157) | 16.05 mg/dL | Standard Deviation 5.19 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,185 (n=82,37) | 99.29 mg/dL | Standard Deviation 30.71 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,457 (n=292, 130) | 9.26 mg/dL | Standard Deviation 0.45 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 2,185 (n=82,37) | 4.61 mg/dL | Standard Deviation 1.22 |
| ABA + MTX DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 729 (n=328, 143) | 0.74 mg/dL | Standard Deviation 0.18 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 2,185 (n=82,37) | 4.60 mg/dL | Standard Deviation 1.39 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,821 (n=262,124) | 14.88 mg/dL | Standard Deviation 3.96 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,073 (n=81,38) | 3.52 mg/dL | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,073 (n=81,38) | 111.1 mg/dL | Standard Deviation 97.97 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 2,073 (n=81,38) | 4.60 mg/dL | Standard Deviation 1.37 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,185 (n=82,37) | 0.52 mg/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,185 (n=82,37) | 3.54 mg/dL | Standard Deviation 0.61 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 365 (n=365, 157) | 0.48 mg/dL | Standard Deviation 0.23 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Blood Urea Nitrogen (BUN) Day 365 (n=365, 157) | 15.09 mg/dL | Standard Deviation 4.41 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 365 (n=365, 157) | 0.74 mg/dL | Standard Deviation 0.17 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 365 (n=365, 157) | 9.26 mg/dL | Standard Deviation 0.5 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 365 (n=365, 157) | 3.56 mg/dL | Standard Deviation 0.54 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 365 (n=365, 157) | 98.78 mg/dL | Standard Deviation 58.76 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 365 (n=365, 157) | 4.83 mg/dL | Standard Deviation 1.5 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 729 (n=328, 143) | 0.48 mg/dL | Standard Deviation 0.23 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 729 (n=328, 143) | 15.03 mg/dL | Standard Deviation 4.4 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,093 (n=312, 138) | 97.65 mg/dL | Standard Deviation 61.54 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 729 (n=328, 143) | 0.73 mg/dL | Standard Deviation 0.17 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 729 (n=328, 143) | 9.24 mg/dL | Standard Deviation 0.5 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 729 (n=328, 143) | 3.55 mg/dL | Standard Deviation 0.5 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 729 (n=328, 143) | 98.56 mg/dL | Standard Deviation 60.79 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 729 (n=328, 143) | 4.75 mg/dL | Standard Deviation 1.34 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,093 (n=312, 138) | 0.48 mg/dL | Standard Deviation 0.22 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,093 (n=312, 138) | 0.00 mg/dL | Standard Deviation 0.4 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,093 (n=312, 138) | 0.74 mg/dL | Standard Deviation 0.17 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,093 (n=312, 138) | 0.02 mg/dL | Standard Deviation 0.04 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,093 (n=312, 138) | 0.10 mg/dL | Standard Deviation 0.05 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,093 (n=312, 138) | -0.32 mg/dL | Standard Deviation 0.09 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,457 (n=292, 130) | 0.49 mg/dL | Standard Deviation 0.23 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,457 (n=292, 130) | 15.02 mg/dL | Standard Deviation 4.36 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,457 (n=292, 130) | 0.74 mg/dL | Standard Deviation 0.18 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,457 (n=292, 130) | 9.25 mg/dL | Standard Deviation 0.46 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,457 (n=292, 130) | 3.54 mg/dL | Standard Deviation 0.5 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,457 (n=292, 130) | 95.35 mg/dL | Standard Deviation 55.47 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,457 (n=292, 130) | 4.75 mg/dL | Standard Deviation 1.32 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,821 (n=262,124) | 0.74 mg/dL | Standard Deviation 0.18 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,821 (n=262,124) | 9.25 mg/dL | Standard Deviation 0.46 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,821 (n=262,124) | 3.54 mg/dL | Standard Deviation 0.51 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,821 (n=262,124) | 98.59 mg/dL | Standard Deviation 64.79 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,821 (n=262,124) | 4.68 mg/dL | Standard Deviation 1.31 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,905 (n=134, 68) | 0.50 mg/dL | Standard Deviation 0.25 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,905 (n=134, 68) | 14.77 mg/dL | Standard Deviation 3.78 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,905 (n=134, 68) | 0.75 mg/dL | Standard Deviation 0.16 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,905 (n=134, 68) | 9.30 mg/dL | Standard Deviation 0.4 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,905 (n=134, 68) | 3.44 mg/dL | Standard Deviation 0.52 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,905 (n=134, 68) | 101.1 mg/dL | Standard Deviation 74.67 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,905 (n=134, 68) | 4.93 mg/dL | Standard Deviation 1.3 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,989 (n=121,56) | 0.52 mg/dL | Standard Deviation 0.27 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 1,989 (n=121,56) | 15.18 mg/dL | Standard Deviation 3.88 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 1,989 (n=121,56) | 0.72 mg/dL | Standard Deviation 0.15 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,989 (n=121,56) | 9.33 mg/dL | Standard Deviation 0.42 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,989 (n=121,56) | 3.45 mg/dL | Standard Deviation 0.53 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,989 (n=121,56) | 104.80 mg/dL | Standard Deviation 81.64 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Uric Acid Day 1,989 (n=121,56) | 4.99 mg/dL | Standard Deviation 1.36 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,073 (n=81,38) | 0.52 mg/dL | Standard Deviation 0.3 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 2,073 (n=81,38) | 15.27 mg/dL | Standard Deviation 3.91 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 2,073 (n=81,38) | 0.69 mg/dL | Standard Deviation 0.13 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,073 (n=81,38) | 9.48 mg/dL | Standard Deviation 0.38 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | BUN Day 2,185 (n=82,37) | 15.22 mg/dL | Standard Deviation 3.95 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Creatinine Day 2,185 (n=82,37) | 0.69 mg/dL | Standard Deviation 0.13 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,185 (n=82,37) | 9.48 mg/dL | Standard Deviation 0.38 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,185 (n=82,37) | 111.4 mg/dL | Standard Deviation 99.31 |
| MTX + Placebo DB | Mean BL Select Laboratory Parameters in the OL Period | Total Bilirubin Day Day 1,821 (n=262,124) | 0.50 mg/dL | Standard Deviation 0.23 |
Primary
Mean BL Serum Electrolytes in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 365 (n=365, 157) | 104.1 mEq/L | Standard Deviation 3.17 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,457 (n=292, 130) | 139.9 mEq/L | Standard Deviation 2.83 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,989 (n=121,56) | 103.8 mEq/L | Standard Deviation 3.61 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,457 (n=292, 130) | 4.27 mEq/L | Standard Deviation 0.35 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 729 (n=328, 143) | 139.8 mEq/L | Standard Deviation 2.97 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,457 (n=292, 130) | 104.0 mEq/L | Standard Deviation 3.06 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,905 (n=134, 68) | 103.9 mEq/L | Standard Deviation 3.44 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,821 (n=262,124) | 140.0 mEq/L | Standard Deviation 2.84 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 729 (n=328, 143) | 4.27 mEq/L | Standard Deviation 0.36 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,821 (n=262,124) | 4.26 mEq/L | Standard Deviation 0.36 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 365 (n=365, 157) | 139.9 mEq/L | Standard Deviation 2.89 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,821 (n=262,124) | 104.1 mEq/L | Standard Deviation 3.08 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 729 (n=328, 143) | 103.9 mEq/L | Standard Deviation 3.13 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,905 (n=134, 68) | 139.6 mEq/L | Standard Deviation 3.13 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,989 (n=121,56) | 4.27 mEq/L | Standard Deviation 0.41 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 2,073 (n=81,38) | 138.2 mEq/L | Standard Deviation 2.33 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,093 (n=312, 138) | 139.9 mEq/L | Standard Deviation 2.88 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 2,073 (n=81,38) | 4.31 mEq/L | Standard Deviation 0.44 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 365 (n=365, 157) | 4.27 mEq/L | Standard Deviation 0.37 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 2,073 (n=81,38) | 102.3 mEq/L | Standard Deviation 2.57 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,093 (n=312, 138) | 4.27 mEq/L | Standard Deviation 0.36 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 2,185 (n=82,37) | 138.2 mEq/L | Standard Deviation 2.31 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,989 (n=121,56) | 139.5 mEq/L | Standard Deviation 3.14 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 2,185 (n=82,37) | 4.30 mEq/L | Standard Deviation 0.43 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,093 (n=312, 138) | 104.0 mEq/L | Standard Deviation 3.08 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 2,185 (n=82,37) | 102.3 mEq/L | Standard Deviation 2.51 |
| ABA + MTX DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,905 (n=134, 68) | 4.25 mEq/L | Standard Deviation 0.37 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 2,185 (n=82,37) | 102.9 mEq/L | Standard Deviation 4.24 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,905 (n=134, 68) | 4.25 mEq/L | Standard Deviation 0.42 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,905 (n=134, 68) | 104.9 mEq/L | Standard Deviation 4.03 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,989 (n=121,56) | 140.1 mEq/L | Standard Deviation 3.72 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,989 (n=121,56) | 4.24 mEq/L | Standard Deviation 0.43 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,989 (n=121,56) | 104.8 mEq/L | Standard Deviation 4.33 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 365 (n=365, 157) | 140.7 mEq/L | Standard Deviation 3.03 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 365 (n=365, 157) | 4.29 mEq/L | Standard Deviation 0.43 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 365 (n=365, 157) | 105.0 mEq/L | Standard Deviation 3.63 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 729 (n=328, 143) | 140.7 mEq/L | Standard Deviation 3.06 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 729 (n=328, 143) | 4.30 mEq/L | Standard Deviation 0.42 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 729 (n=328, 143) | 104.9 mEq/L | Standard Deviation 3.65 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,093 (n=312, 138) | 140.7 mEq/L | Standard Deviation 3.11 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,093 (n=312, 138) | 4.27 mEq/L | Standard Deviation 0.39 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,093 (n=312, 138) | 104.9 mEq/L | Standard Deviation 3.64 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,457 (n=292, 130) | 140.7 mEq/L | Standard Deviation 3.16 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,457 (n=292, 130) | 4.27 mEq/L | Standard Deviation 0.38 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,457 (n=292, 130) | 105.0 mEq/L | Standard Deviation 3.64 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,821 (n=262,124) | 140.7 mEq/L | Standard Deviation 3.11 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 1,821 (n=262,124) | 4.28 mEq/L | Standard Deviation 0.4 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 1,821 (n=262,124) | 104.8 mEq/L | Standard Deviation 3.6 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 1,905 (n=134, 68) | 140.5 mEq/L | Standard Deviation 3.56 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 2,073 (n=81,38) | 139.0 mEq/L | Standard Deviation 3.91 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 2,073 (n=81,38) | 4.27 mEq/L | Standard Deviation 0.48 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Chloride Day 2,073 (n=81,38) | 103.0 mEq/L | Standard Deviation 4.23 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Sodium Day 2,185 (n=82,37) | 138.9 mEq/L | Standard Deviation 3.93 |
| MTX + Placebo DB | Mean BL Serum Electrolytes in the OL Period | Serum Potassium Day 2,185 (n=82,37) | 4.28 mEq/L | Standard Deviation 0.49 |
Primary
Mean BL White Blood Cells in the OL Period
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,457 (n=292, 130) | 6.43 10^3 c/uL | Standard Deviation 2.59 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,821 (n=262,124) | 0.42 10^3 c/uL | Standard Deviation 0.24 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 729 (n=328, 143) | 8.89 10^3 c/uL | Standard Deviation 2.87 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 365 (n=365, 157) | 0.42 10^3 c/uL | Standard Deviation 0.25 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 729 (n=328, 143) | 6.50 10^3 c/uL | Standard Deviation 2.63 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,905 (n=134, 68) | 9.14 10^3 c/uL | Standard Deviation 2.83 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 729 (n=328, 143) | 0.18 10^3 c/uL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,905 (n=134, 68) | 6.78 10^3 c/uL | Standard Deviation 2.67 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 729 (n=328, 143) | 0.43 10^3 c/uL | Standard Deviation 0.25 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 365 (n=365, 157) | 8.78 10^3 c/uL | Standard Deviation 2.83 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,093 (n=312, 138) | 8.81 10^3 c/uL | Standard Deviation 2.83 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,457 (n=292, 130) | 0.18 10^3 c/uL | Standard Deviation 0.17 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,093 (n=312, 138) | 6.46 10^3 c/uL | Standard Deviation 2.63 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,905 (n=134, 68) | 0.17 10^3 c/uL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,093 (n=312, 138) | 0.18 10^3 c/uL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 365 (n=365, 157) | 0.18 10^3 c/uL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,093 (n=312, 138) | 0.43 10^3 c/uL | Standard Deviation 0.25 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,457 (n=292, 130) | 0.43 10^3 c/uL | Standard Deviation 0.25 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,905 (n=134, 68) | 0.37 10^3 c/uL | Standard Deviation 0.21 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,821 (n=262,124) | 8.82 10^3 c/uL | Standard Deviation 2.76 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,457 (n=292, 130) | 8.80 10^3 c/uL | Standard Deviation 2.81 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,989 (n=121,56) | 9.16 10^3 c/uL | Standard Deviation 2.87 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,989 (n=121,56) | 0.35 10^3 c/uL | Standard Deviation 0.21 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,821 (n=262,124) | 6.45 10^3 c/uL | Standard Deviation 2.56 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 2,073 (n=81,38) | 0.12 10^3 c/uL | Standard Deviation 0.1 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,989 (n=121,56) | 6.86 10^3 c/uL | Standard Deviation 2.77 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 2,073 (n=81,38) | 0.41 10^3 c/uL | Standard Deviation 0.22 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 365 (n=365, 157) | 6.45 10^3 c/uL | Standard Deviation 2.63 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 2,185 (n=82,37) | 9.73 10^3 c/uL | Standard Deviation 2.98 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,989 (n=121,56) | 0.15 10^3 c/uL | Standard Deviation 0.14 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 2,185 (n=82,37) | 7.35 10^3 c/uL | Standard Deviation 2.84 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 2,073 (n=81,38) | 9.64 10^3 c/uL | Standard Deviation 3.05 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 2,185 (n=82,37) | 0.12 10^3 c/uL | Standard Deviation 0.11 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,821 (n=262,124) | 0.18 10^3 c/uL | Standard Deviation 0.16 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 2,185 (n=82,37) | 0.40 10^3 c/uL | Standard Deviation 0.22 |
| ABA + MTX DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 2,073 (n=81,38) | 7.25 10^3 c/uL | Standard Deviation 2.9 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 729 (n=328, 143) | 0.40 10^3 c/uL | Standard Deviation 0.25 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 365 (n=365, 157) | 8.81 10^3 c/uL | Standard Deviation 3.01 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 365 (n=365, 157) | 6.39 10^3 c/uL | Standard Deviation 2.67 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 365 (n=365, 157) | 0.18 10^3 c/uL | Standard Deviation 0.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,093 (n=312, 138) | 0.41 10^3 c/uL | Standard Deviation 0.27 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,457 (n=292, 130) | 8.74 10^3 c/uL | Standard Deviation 3.1 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,457 (n=292, 130) | 6.32 10^3 c/uL | Standard Deviation 2.73 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,457 (n=292, 130) | 0.18 10^3 c/uL | Standard Deviation 0.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,821 (n=262,124) | 8.70 10^3 c/uL | Standard Deviation 3.06 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,821 (n=262,124) | 6.35 10^3 c/uL | Standard Deviation 2.72 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,821 (n=262,124) | 0.18 10^3 c/uL | Standard Deviation 0.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,821 (n=262,124) | 0.39 10^3 c/uL | Standard Deviation 0.22 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,905 (n=134, 68) | 6.56 10^3 c/uL | Standard Deviation 2.68 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,905 (n=134, 68) | 0.16 10^3 c/uL | Standard Deviation 0.11 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,905 (n=134, 68) | 0.34 10^3 c/uL | Standard Deviation 0.19 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,989 (n=121,56) | 8.81 10^3 c/uL | Standard Deviation 2.93 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,989 (n=121,56) | 6.69 10^3 c/uL | Standard Deviation 2.74 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 2,073 (n=81,38) | 9.22 10^3 c/uL | Standard Deviation 3.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 2,073 (n=81,38) | 6.97 10^3 c/uL | Standard Deviation 2.99 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 365 (n=365, 157) | 0.41 10^3 c/uL | Standard Deviation 0.26 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 729 (n=328, 143) | 8.73 10^3 c/uL | Standard Deviation 2.96 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 729 (n=328, 143) | 6.35 10^3 c/uL | Standard Deviation 2.66 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 729 (n=328, 143) | 0.18 10^3 c/uL | Standard Deviation 0.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,093 (n=312, 138) | 8.80 10^3 c/uL | Standard Deviation 3.08 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 1,093 (n=312, 138) | 6.37 10^3 c/uL | Standard Deviation 2.71 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,093 (n=312, 138) | 0.18 10^3 c/uL | Standard Deviation 0.12 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,457 (n=292, 130) | 0.40 10^3 c/uL | Standard Deviation 0.25 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 1,905 (n=134, 68) | 8.80 10^3 c/uL | Standard Deviation 2.91 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 1,989 (n=121,56) | 0.15 10^3 c/uL | Standard Deviation 0.1 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 1,989 (n=121,56) | 0.35 10^3 c/uL | Standard Deviation 0.18 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 2,073 (n=81,38) | 0.13 10^3 c/uL | Standard Deviation 0.09 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 2,073 (n=81,38) | 0.38 10^3 c/uL | Standard Deviation 0.19 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | White Blood Cells Day 2,185 (n=82,37) | 9.22 10^3 c/uL | Standard Deviation 3.16 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Neutrophils Day 2,185 (n=82,37) | 6.93 10^3 c/uL | Standard Deviation 3.03 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Eosinophils Day 2,185 (n=82,37) | 0.13 10^3 c/uL | Standard Deviation 0.09 |
| MTX + Placebo DB | Mean BL White Blood Cells in the OL Period | Absolute Monocytes Day 2,185 (n=82,37) | 0.38 10^3 c/uL | Standard Deviation 0.2 |
Primary
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,989 (n=121,56) | 0.59 g/dL | Standard Error 0.13 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,073 (n=81,38) | 0.22 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,093 (n=312, 138) | 0.75 g/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,821 (n=262,124) | 0.06 g/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,185 (n=82,37) | 0.69 g/dL | Standard Error 0.14 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,457 (n=292, 130) | 0.80 g/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,093 (n=312, 138) | -0.16 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,457 (n=292, 130) | -0.28 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 365 (n=365, 157) | 0.62 g/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,457 (n=292, 130) | 0.07 g/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,905 (n=134, 68) | 0.74 g/dL | Standard Error 0.12 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,821 (n=262,124) | 0.79 g/dL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,905 (n=134, 68) | -0.32 g/dL | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 365 (n=365, 157) | 0.22 g/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,905 (n=134, 68) | 0.05 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,821 (n=262,124) | -0.27 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 729 (n=328, 143) | 0.95 g/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,989 (n=121,56) | -0.29 g/dL | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,073 (n=81,38) | -0.21 g/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,989 (n=121,56) | 0.08 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 729 (n=328, 143) | -0.01 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,073 (n=81,38) | 0.78 g/dL | Standard Error 0.15 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,093 (n=312, 138) | 0.13 g/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,185 (n=82,37) | -0.20 g/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 729 (n=328, 143) | 0.31 g/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,185 (n=82,37) | 0.30 g/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 365 (n=365, 157) | -0.26 g/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,185 (n=82,37) | 0.25 g/dL | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 365 (n=365, 157) | -0.25 g/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,093 (n=312, 138) | -0.26 g/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,821 (n=262,124) | 0.70 g/dL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,821 (n=262,124) | -0.35 g/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,821 (n=262,124) | -0.05 g/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,905 (n=134, 68) | 0.39 g/dL | Standard Error 0.16 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,073 (n=81,38) | -0.24 g/dL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 2,073 (n=81,38) | 0.09 g/dL | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,185 (n=82,37) | 0.40 g/dL | Standard Error 0.21 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 365 (n=365, 157) | -0.09 g/dL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 365 (n=365, 157) | 0.02 g/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 729 (n=328, 143) | 0.61 g/dL | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 729 (n=328, 143) | -0.05 g/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 729 (n=328, 143) | 0.23 g/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,093 (n=312, 138) | 0.40 g/dL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,093 (n=312, 138) | 0.02 g/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,457 (n=292, 130) | 0.52 g/dL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,457 (n=292, 130) | -0.35 g/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,457 (n=292, 130) | -0.02 g/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,905 (n=134, 68) | -0.31 g/dL | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,905 (n=134, 68) | -0.06 g/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 1,989 (n=121,56) | 0.41 g/dL | Standard Error 0.17 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 1,989 (n=121,56) | -0.33 g/dL | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Albumin Day 1,989 (n=121,56) | 0.01 g/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Hemoglobin Day 2,073 (n=81,38) | 0.23 g/dL | Standard Error 0.22 |
| MTX + Placebo DB | Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period | Total Protein Day 2,185 (n=82,37) | -0.12 g/dL | Standard Error 0.09 |
Primary
Mean Change From BL in Immunoglobulins in the OL Period
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 729 | -38.6 mg / mL | Standard Error 4.24 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 729 | 8.04 mg / mL | Standard Error 3.96 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 365 | -212 mg / mL | Standard Error 12.77 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 1,093 | -46.8 mg / mL | Standard Error 4.76 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 365 | -47.8 mg / mL | Standard Error 3.16 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 1,093 | -236 mg / mL | Standard Error 15.94 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 365 | -5.05 mg / mL | Standard Error 1.98 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 1,093 | 4.38 mg / mL | Standard Error 3.19 |
| ABA + MTX DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 729 | -215 mg / mL | Standard Error 14.1 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 1,093 | 6.01 mg / mL | Standard Error 5.01 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 729 | -26.6 mg / mL | Standard Error 9.95 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 365 | -8.30 mg / mL | Standard Error 6.41 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 365 | -52.7 mg / mL | Standard Error 18.96 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 729 | -206 mg / mL | Standard Error 21.86 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 729 | 6.49 mg / mL | Standard Error 5.76 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgA Day 1,093 | -37.9 mg / mL | Standard Error 9.66 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgG Day 1,093 | -245 mg / mL | Standard Error 25.44 |
| MTX + Placebo DB | Mean Change From BL in Immunoglobulins in the OL Period | IgM Day 365 | 6.95 mg / mL | Standard Error 9.73 |
Primary
Mean Change From BL in Liver Function Parameters in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,989 (n=121,56) | -1.41 U/L | Standard Error 2.04 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 729 (n=328, 143) | 0.39 U/L | Standard Error 1.39 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,073 (n=81,38) | -10.6 U/L | Standard Error 3.4 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 365 (n=365, 157) | -7.27 U/L | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 365 (n=365, 157) | 1.10 U/L | Standard Error 1.25 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 365 (n=365, 157) | 1.50 U/L | Standard Error 0.76 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 365 (n=365, 157) | -4.42 U/L | Standard Error 1.48 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 729 (n=328, 143) | -13.3 U/L | Standard Error 1.7 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 729 (n=328, 143) | 1.30 U/L | Standard Error 0.83 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 729 (n=328, 143) | -4.96 U/L | Standard Error 1.62 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,093 (n=312, 138) | -10.0 U/L | Standard Error 1.69 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,093 (n=312, 138) | 0.81 U/L | Standard Error 1.4 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,093 (n=312, 138) | 1.11 U/L | Standard Error 0.85 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,093 (n=312, 138) | -6.81 U/L | Standard Error 1.55 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,457 (n=292, 130) | -12.4 U/L | Standard Error 1.73 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,457 (n=292, 130) | 1.43 U/L | Standard Error 2.66 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,457 (n=292, 130) | 1.40 U/L | Standard Error 1.73 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,457 (n=292, 130) | -5.15 U/L | Standard Error 2.35 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,821 (n=262,124) | -14.6 U/L | Standard Error 1.7 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,821 (n=262,124) | -0.95 U/L | Standard Error 1.49 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,821 (n=262,124) | 0.14 U/L | Standard Error 0.85 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,821 (n=262,124) | -5.63 U/L | Standard Error 2.04 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,905 (n=134, 68) | -14.9 U/L | Standard Error 2.82 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,905 (n=134, 68) | -2.35 U/L | Standard Error 2.03 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,905 (n=134, 68) | -0.49 U/L | Standard Error 1.18 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,905 (n=134, 68) | -6.76 U/L | Standard Error 3.16 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,989 (n=121,56) | -12.4 U/L | Standard Error 2.8 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,989 (n=121,56) | 0.20 U/L | Standard Error 1.24 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,989 (n=121,56) | -3.66 U/L | Standard Error 3.58 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,073 (n=81,38) | -0.56 U/L | Standard Error 2.82 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 2,073 (n=81,38) | 0.95 U/L | Standard Error 1.68 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,073 (n=81,38) | -10.2 U/L | Standard Error 4.23 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,185 (n=82,37) | -14.2 U/L | Standard Error 2.79 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | -2.56 U/L | Standard Error 2.84 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | 0.60 U/L | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,185 (n=82,37) | -13.9 U/L | Standard Error 3.81 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,821 (n=262,124) | -14.7 U/L | Standard Error 1.99 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,073 (n=81,38) | -4.92 U/L | Standard Error 3.49 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,989 (n=121,56) | -4.00 U/L | Standard Error 2.95 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,821 (n=262,124) | -0.75 U/L | Standard Error 2.65 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,073 (n=81,38) | -4.24 U/L | Standard Error 3.57 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,989 (n=121,56) | -1.71 U/L | Standard Error 2.98 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 365 (n=365, 157) | -10.8 U/L | Standard Error 2.3 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,821 (n=262,124) | -0.52 U/L | Standard Error 1.52 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 365 (n=365, 157) | -2.64 U/L | Standard Error 2.18 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 2,185 (n=82,37) | -4.51 U/L | Standard Error 2.95 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 365 (n=365, 157) | -1.42 U/L | Standard Error 1.2 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,821 (n=262,124) | -4.65 U/L | Standard Error 1.55 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 365 (n=365, 157) | -2.83 U/L | Standard Error 1.79 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 2,185 (n=82,37) | -7.76 U/L | Standard Error 3.4 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 729 (n=328, 143) | -1.69 U/L | Standard Error 2.38 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,905 (n=134, 68) | -10.6 U/L | Standard Error 3.19 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 729 (n=328, 143) | 0.47 U/L | Standard Error 1.43 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,073 (n=81,38) | -8.08 U/L | Standard Error 7.91 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 729 (n=328, 143) | -3.98 U/L | Standard Error 1.68 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,905 (n=134, 68) | -5.74 U/L | Standard Error 4.66 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,093 (n=312, 138) | -13.0 U/L | Standard Error 2.74 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | -1.43 U/L | Standard Error 4.64 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,093 (n=312, 138) | -0.17 U/L | Standard Error 2.52 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,905 (n=134, 68) | -3.00 U/L | Standard Error 2.46 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,093 (n=312, 138) | 0.07 U/L | Standard Error 1.39 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 2,073 (n=81,38) | -2.37 U/L | Standard Error 4.26 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,093 (n=312, 138) | -4.51 U/L | Standard Error 1.54 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,905 (n=134, 68) | -3.09 U/L | Standard Error 2.91 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,457 (n=292, 130) | -12.0 U/L | Standard Error 3.02 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 2,185 (n=82,37) | -7.43 U/L | Standard Error 8.65 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,457 (n=292, 130) | -3.11 U/L | Standard Error 2.57 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 1,989 (n=121,56) | -13.0 U/L | Standard Error 3.8 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Aspartate Aminotransferase Day 1,457 (n=292, 130) | -1.82 U/L | Standard Error 1.4 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alkaline Phosphatase Day 729 (n=328, 143) | -18.8 U/L | Standard Error 2.85 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | G-Glutamyl Transferase Day 1,457 (n=292, 130) | -3.66 U/L | Standard Error 1.54 |
| MTX + Placebo DB | Mean Change From BL in Liver Function Parameters in the OL Period | Alanine Aminotransferase Day 1,989 (n=121,56) | -4.98 U/L | Standard Error 5.6 |
Primary
Mean Change From BL in Participant Hematocrit in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 2,185 (n=82,37) | 1.42 Percentage Blood Volume Occupied by RBCs | Standard Error 0.37 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,821 (n=262,124) | 0.85 Percentage Blood Volume Occupied by RBCs | Standard Error 0.25 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,093 (n=312, 138) | 1.41 Percentage Blood Volume Occupied by RBCs | Standard Error 0.2 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,905 (n=134, 68) | 1.63 Percentage Blood Volume Occupied by RBCs | Standard Error 0.34 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 729 (n=328, 143) | 2.16 Percentage Blood Volume Occupied by RBCs | Standard Error 0.2 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,989 (n=121,56) | 1.42 Percentage Blood Volume Occupied by RBCs | Standard Error 0.38 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,457 (n=292, 130) | 1.60 Percentage Blood Volume Occupied by RBCs | Standard Error 0.23 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 2,073 (n=81,38) | 1.79 Percentage Blood Volume Occupied by RBCs | Standard Error 0.42 |
| ABA + MTX DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 365 (n=365, 157) | 1.87 Percentage Blood Volume Occupied by RBCs | Standard Error 0.21 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 2,073 (n=81,38) | 0.20 Percentage Blood Volume Occupied by RBCs | Standard Error 0.62 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 365 (n=365, 157) | -0.04 Percentage Blood Volume Occupied by RBCs | Standard Error 0.24 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 2,185 (n=82,37) | 0.65 Percentage Blood Volume Occupied by RBCs | Standard Error 0.61 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 729 (n=328, 143) | 1.36 Percentage Blood Volume Occupied by RBCs | Standard Error 0.31 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,093 (n=312, 138) | 0.56 Percentage Blood Volume Occupied by RBCs | Standard Error 0.35 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,457 (n=292, 130) | 1.01 Percentage Blood Volume Occupied by RBCs | Standard Error 0.38 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,821 (n=262,124) | 0.78 Percentage Blood Volume Occupied by RBCs | Standard Error 0.34 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,905 (n=134, 68) | 0.59 Percentage Blood Volume Occupied by RBCs | Standard Error 0.48 |
| MTX + Placebo DB | Mean Change From BL in Participant Hematocrit in the OL Period | Day 1,989 (n=121,56) | 0.94 Percentage Blood Volume Occupied by RBCs | Standard Error 0.49 |
Primary
Mean Change From BL in Participant Platelet Count in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 729 (n=328, 143) | -59.5 10^9 c/L | Standard Error 4.64 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,905 (n=134, 68) | -55.1 10^9 c/L | Standard Error 14.57 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,457 (n=292, 130) | -59.0 10^9 c/L | Standard Error 5.64 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,989 (n=121,56) | -63.7 10^9 c/L | Standard Error 8.33 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,093 (n=312, 138) | -53.5 10^9 c/L | Standard Error 5.1 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 2,073 (n=81,38) | -69.6 10^9 c/L | Standard Error 10.64 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,821 (n=262,124) | -68.9 10^9 c/L | Standard Error 4.92 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 2,185 (n=82,37) | -80.5 10^9 c/L | Standard Error 10.68 |
| ABA + MTX DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 365 (n=365, 157) | -66.9 10^9 c/L | Standard Error 4.29 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 2,185 (n=82,37) | -53.9 10^9 c/L | Standard Error 10.34 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 365 (n=365, 157) | -29.9 10^9 c/L | Standard Error 5.58 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 729 (n=328, 143) | -45.4 10^9 c/L | Standard Error 6.64 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,093 (n=312, 138) | -36.8 10^9 c/L | Standard Error 7.21 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,457 (n=292, 130) | -48.7 10^9 c/L | Standard Error 7.4 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,821 (n=262,124) | -59.2 10^9 c/L | Standard Error 7.38 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,905 (n=134, 68) | -47.5 10^9 c/L | Standard Error 10.71 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 1,989 (n=121,56) | -50.3 10^9 c/L | Standard Error 9.83 |
| MTX + Placebo DB | Mean Change From BL in Participant Platelet Count in the OL Period | Day 2,073 (n=81,38) | -55.3 10^9 c/L | Standard Error 11.68 |
Primary
Mean Change From BL in Select Laboratory Parameters in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 729 (n=328, 143) | 0.14 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day Day 1,821 (n=262,124) | 0.01 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,821 (n=262,124) | -0.07 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,821 (n=262,124) | -0.54 mg/dL | Standard Error 0.28 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 729 (n=328, 143) | -0.06 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,821 (n=262,124) | -0.01 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 365 (n=365, 157) | 0.25 mg/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,821 (n=262,124) | 3.27 mg/dL | Standard Error 1.86 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 729 (n=328, 143) | -1.77 mg/dL | Standard Error 1.67 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,821 (n=262,124) | -0.13 mg/dL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,185 (n=82,37) | -0.27 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,905 (n=134, 68) | 0.01 mg/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 729 (n=328, 143) | 0.11 mg/dL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,905 (n=134, 68) | -0.36 mg/dL | Standard Error 0.39 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 365 (n=365, 157) | -0.02 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,905 (n=134, 68) | -0.04 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,093 (n=312, 138) | 0.05 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,905 (n=134, 68) | -0.12 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,093 (n=312, 138) | -0.15 mg/dL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,905 (n=134, 68) | -0.03 mg/dL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,093 (n=312, 138) | -0.36 mg/dL | Standard Error 0.26 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,905 (n=134, 68) | 3.00 mg/dL | Standard Error 2.96 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 365 (n=365, 157) | -1.65 mg/dL | Standard Error 1.26 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,905 (n=134, 68) | -0.29 mg/dL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,093 (n=312, 138) | -0.00 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,989 (n=121,56) | 0.01 mg/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 365 (n=365, 157) | 0.06 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,989 (n=121,56) | -0.31 mg/dL | Standard Error 0.45 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,093 (n=312, 138) | 0.04 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,989 (n=121,56) | -0.01 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 365 (n=365, 157) | 0.04 mg/dL | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,989 (n=121,56) | -0.10 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,093 (n=312, 138) | 0.02 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,989 (n=121,56) | -0.07 mg/dL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,821 (n=262,124) | 0.02 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,989 (n=121,56) | -1.58 mg/dL | Standard Error 2.85 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,093 (n=312, 138) | 0.36 mg/dL | Standard Error 1.63 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,989 (n=121,56) | -0.29 mg/dL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,457 (n=292, 130) | 0.01 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,073 (n=81,38) | 0.04 mg/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 729 (n=328, 143) | 0.09 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 2,073 (n=81,38) | 0.33 mg/dL | Standard Error 0.47 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,457 (n=292, 130) | -0.48 mg/dL | Standard Error 0.27 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 2,073 (n=81,38) | 0.05 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Blood Urea Nitrogen (BUN) Day 365 (n=365, 157) | 16.05 mg/dL | Standard Error 5.19 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,073 (n=81,38) | -0.10 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,457 (n=292, 130) | 0.02 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,073 (n=81,38) | -0.11 mg/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 729 (n=328, 143) | -0.38 mg/dL | Standard Error 0.31 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,457 (n=292, 130) | -0.08 mg/dL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 2,073 (n=81,38) | -0.08 mg/dL | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,073 (n=81,38) | -0.74 mg/dL | Standard Error 3.13 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,185 (n=82,37) | 0.05 mg/dL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,457 (n=292, 130) | -0.00 mg/dL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 2,185 (n=82,37) | 0.51 mg/dL | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 729 (n=328, 143) | 0.08 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 2,185 (n=82,37) | 0.03 mg/dL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,185 (n=82,37) | -0.14 mg/dL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,457 (n=292, 130) | 0.43 mg/dL | Standard Error 1.53 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,185 (n=82,37) | 6.85 mg/dL | Standard Error 3.81 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 365 (n=365, 157) | 0.74 mg/dL | Standard Error 0.17 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 2,185 (n=82,37) | -0.12 mg/dL | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,457 (n=292, 130) | -0.19 mg/dL | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 2,185 (n=82,37) | -0.17 mg/dL | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,093 (n=312, 138) | -0.32 mg/dL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,821 (n=262,124) | -0.04 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,821 (n=262,124) | -0.04 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 2,185 (n=82,37) | 0.04 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,185 (n=82,37) | -0.19 mg/dL | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 365 (n=365, 157) | 0.00 mg/dL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Blood Urea Nitrogen (BUN) Day 365 (n=365, 157) | 15.09 mg/dL | Standard Error 4.41 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 365 (n=365, 157) | 0.74 mg/dL | Standard Error 0.17 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 365 (n=365, 157) | 0.22 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 365 (n=365, 157) | -0.12 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 365 (n=365, 157) | -4.06 mg/dL | Standard Error 4.29 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 365 (n=365, 157) | -0.06 mg/dL | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 729 (n=328, 143) | 0.05 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 729 (n=328, 143) | -0.06 mg/dL | Standard Error 0.35 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 729 (n=328, 143) | 0.08 mg/dL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 729 (n=328, 143) | 0.18 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 729 (n=328, 143) | -0.10 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 729 (n=328, 143) | -4.74 mg/dL | Standard Error 5.18 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 729 (n=328, 143) | 0.00 mg/dL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,093 (n=312, 138) | 0.01 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,093 (n=312, 138) | 0.00 mg/dL | Standard Error 0.4 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,093 (n=312, 138) | -0.03 mg/dL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,093 (n=312, 138) | 0.02 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,093 (n=312, 138) | 0.10 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,457 (n=292, 130) | -0.04 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,457 (n=292, 130) | -0.47 mg/dL | Standard Error 0.42 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,457 (n=292, 130) | -0.03 mg/dL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,457 (n=292, 130) | -0.08 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,457 (n=292, 130) | 0.02 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,457 (n=292, 130) | -0.12 mg/dL | Standard Error 5.09 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,457 (n=292, 130) | -0.43 mg/dL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day Day 1,821 (n=262,124) | -0.01 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,821 (n=262,124) | 0.30 mg/dL | Standard Error 0.44 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,821 (n=262,124) | 0.01 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,821 (n=262,124) | -0.02 mg/dL | Standard Error 5.51 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,821 (n=262,124) | -0.30 mg/dL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,905 (n=134, 68) | -0.05 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,905 (n=134, 68) | 0.56 mg/dL | Standard Error 0.57 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,905 (n=134, 68) | -0.03 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,905 (n=134, 68) | -0.11 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,905 (n=134, 68) | 0.11 mg/dL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,905 (n=134, 68) | -0.50 mg/dL | Standard Error 9.71 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,905 (n=134, 68) | -0.29 mg/dL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 1,989 (n=121,56) | -0.03 mg/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 1,989 (n=121,56) | 0.09 mg/dL | Standard Error 0.64 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 1,989 (n=121,56) | -0.02 mg/dL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 1,989 (n=121,56) | -0.08 mg/dL | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 1,989 (n=121,56) | 0.08 mg/dL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,989 (n=121,56) | -2.70 mg/dL | Standard Error 11.88 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 1,989 (n=121,56) | -0.38 mg/dL | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,073 (n=81,38) | -0.100 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 2,073 (n=81,38) | 0.84 mg/dL | Standard Error 0.72 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Creatinine Day 2,073 (n=81,38) | 0.04 mg/dL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Calcium Day 2,073 (n=81,38) | -0.20 mg/dL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,073 (n=81,38) | -0.11 mg/dL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,073 (n=81,38) | -18.2 mg/dL | Standard Error 16.92 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Uric Acid Day 2,073 (n=81,38) | -0.15 mg/dL | Standard Error 0.16 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Total Bilirubin Day 2,185 (n=82,37) | 0.00 mg/dL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | BUN Day 2,185 (n=82,37) | 0.18 mg/dL | Standard Error 0.56 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Inorganic Phosphorous Day 2,185 (n=82,37) | -0.13 mg/dL | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 2,185 (n=82,37) | -8.86 mg/dL | Standard Error 17.98 |
| MTX + Placebo DB | Mean Change From BL in Select Laboratory Parameters in the OL Period | Serum Glucose Day 1,093 (n=312, 138) | -4.95 mg/dL | Standard Error 4.84 |
Primary
Mean Change From BL in Serum Electrolytes in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 2,185 (n=82,37) | 2.95 mEq/L | Standard Error 0.4 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 365 (n=365, 157) | -0.42 mEq/L | Standard Error 0.17 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 365 (n=365, 157) | -0.01 mEq/L | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 365 (n=365, 157) | 0.43 mEq/L | Standard Error 0.14 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 729 (n=328, 143) | 0.71 mEq/L | Standard Error 0.19 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 729 (n=328, 143) | -0.03 mEq/L | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 729 (n=328, 143) | 0.63 mEq/L | Standard Error 0.17 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,093 (n=312, 138) | -0.29 mEq/L | Standard Error 0.21 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,093 (n=312, 138) | -0.05 mEq/L | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,093 (n=312, 138) | -0.35 mEq/L | Standard Error 0.18 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,457 (n=292, 130) | -0.18 mEq/L | Standard Error 0.25 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,457 (n=292, 130) | -0.03 mEq/L | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,457 (n=292, 130) | 104.0 mEq/L | Standard Error 3.06 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,821 (n=262,124) | -0.68 mEq/L | Standard Error 0.24 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,821 (n=262,124) | -0.08 mEq/L | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,821 (n=262,124) | -0.19 mEq/L | Standard Error 0.22 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,905 (n=134, 68) | -0.27 mEq/L | Standard Error 0.36 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,905 (n=134, 68) | -0.06 mEq/L | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,905 (n=134, 68) | 0.31 mEq/L | Standard Error 0.33 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,989 (n=121,56) | -0.02 mEq/L | Standard Error 0.4 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,989 (n=121,56) | -0.05 mEq/L | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,989 (n=121,56) | 0.40 mEq/L | Standard Error 0.38 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 2,073 (n=81,38) | 2.56 mEq/L | Standard Error 0.32 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 2,073 (n=81,38) | -0.10 mEq/L | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 2,073 (n=81,38) | 2.27 mEq/L | Standard Error 0.4 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 2,185 (n=82,37) | 2.76 mEq/L | Standard Error 0.34 |
| ABA + MTX DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 2,185 (n=82,37) | -0.11 mEq/L | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 2,073 (n=81,38) | 1.89 mEq/L | Standard Error 0.72 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,821 (n=262,124) | -0.15 mEq/L | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 365 (n=365, 157) | -1.37 mEq/L | Standard Error 0.27 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,989 (n=121,56) | -0.52 mEq/L | Standard Error 0.6 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 365 (n=365, 157) | -0.06 mEq/L | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,821 (n=262,124) | -0.69 mEq/L | Standard Error 0.34 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 365 (n=365, 157) | -0.21 mEq/L | Standard Error 0.25 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 2,185 (n=82,37) | -0.20 mEq/L | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 729 (n=328, 143) | -0.29 mEq/L | Standard Error 0.29 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,905 (n=134, 68) | -0.75 mEq/L | Standard Error 0.54 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 729 (n=328, 143) | -0.12 mEq/L | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 2,073 (n=81,38) | 2.05 mEq/L | Standard Error 0.71 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 729 (n=328, 143) | 0.15 mEq/L | Standard Error 0.27 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,905 (n=134, 68) | -0.06 mEq/L | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,093 (n=312, 138) | -1.34 mEq/L | Standard Error 0.34 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 2,185 (n=82,37) | 2.24 mEq/L | Standard Error 0.68 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,093 (n=312, 138) | -0.08 mEq/L | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,905 (n=134, 68) | -0.15 mEq/L | Standard Error 0.53 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,093 (n=312, 138) | -1.17 mEq/L | Standard Error 0.31 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 2,073 (n=81,38) | -0.14 mEq/L | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,457 (n=292, 130) | -0.88 mEq/L | Standard Error 0.4 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,989 (n=121,56) | -0.25 mEq/L | Standard Error 0.66 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,457 (n=292, 130) | -0.08 mEq/L | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 2,185 (n=82,37) | 1.81 mEq/L | Standard Error 0.72 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Chloride Day 1,457 (n=292, 130) | 105.0 mEq/L | Standard Error 3.64 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Potassium Day 1,989 (n=121,56) | -0.12 mEq/L | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in Serum Electrolytes in the OL Period | Serum Sodium Day 1,821 (n=262,124) | -1.29 mEq/L | Standard Error 0.38 |
Primary
Mean Change From BL in White Blood Cells in the OL Period
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185
Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,821 (n=262,124) | -0.00 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 729 (n=328, 143) | -1.35 10^3 c/uL | Standard Error 0.15 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,821 (n=262,124) | -0.03 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,093 (n=312, 138) | -0.01 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,905 (n=134, 68) | -0.82 10^3 c/uL | Standard Error 0.38 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 365 (n=365, 157) | -0.02 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,905 (n=134, 68) | -1.30 10^3 c/uL | Standard Error 0.31 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,093 (n=312, 138) | -0.07 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,905 (n=134, 68) | -0.00 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 729 (n=328, 143) | -1.50 10^3 c/uL | Standard Error 0.14 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,905 (n=134, 68) | 0.03 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,457 (n=292, 130) | -1.36 10^3 c/uL | Standard Error 0.16 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,989 (n=121,56) | -1.07 10^3 c/uL | Standard Error 0.26 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 729 (n=328, 143) | -0.02 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,989 (n=121,56) | -.152 10^3 c/uL | Standard Error 0.26 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,457 (n=292, 130) | -1.44 10^3 c/uL | Standard Error 0.15 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,989 (n=121,56) | 0.01 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 365 (n=365, 157) | -1.20 10^3 c/uL | Standard Error 0.12 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,989 (n=121,56) | 0.03 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,457 (n=292, 130) | -0.00 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 2,073 (n=81,38) | -1.00 10^3 c/uL | Standard Error 0.33 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 365 (n=365, 157) | -0.03 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 2,073 (n=81,38) | -1.57 10^3 c/uL | Standard Error 0.35 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,457 (n=292, 130) | -0.06 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 2,073 (n=81,38) | 0.02 10^3 c/uL | Standard Error 0.01 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,093 (n=312, 138) | -1.50 10^3 c/uL | Standard Error 0.16 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 2,073 (n=81,38) | 0.13 10^3 c/uL | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,821 (n=262,124) | -1.56 10^3 c/uL | Standard Error 0.18 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 2,185 (n=82,37) | -1.41 10^3 c/uL | Standard Error 0.33 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 365 (n=365, 157) | -.10 10^3 c/uL | Standard Error 0.13 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 2,185 (n=82,37) | -1.78 10^3 c/uL | Standard Error 0.33 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,821 (n=262,124) | -1.72 10^3 c/uL | Standard Error 0.17 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 2,185 (n=82,37) | 0.03 10^3 c/uL | Standard Error 0.02 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,093 (n=312, 138) | -1.57 10^3 c/uL | Standard Error 0.15 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 2,185 (n=82,37) | 0.08 10^3 c/uL | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 729 (n=328, 143) | -0.06 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 2,185 (n=82,37) | 0.08 10^3 c/uL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 729 (n=328, 143) | -1.49 10^3 c/uL | Standard Error 0.19 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 365 (n=365, 157) | -0.44 10^3 c/uL | Standard Error 0.17 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 365 (n=365, 157) | -0.43 10^3 c/uL | Standard Error 0.18 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 365 (n=365, 157) | -0.01 10^3 c/uL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 365 (n=365, 157) | -0.03 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 729 (n=328, 143) | -1.19 10^3 c/uL | Standard Error 0.2 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 729 (n=328, 143) | -0.04 10^3 c/uL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 729 (n=328, 143) | -0.03 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,093 (n=312, 138) | -1.55 10^3 c/uL | Standard Error 0.22 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,093 (n=312, 138) | -1.66 10^3 c/uL | Standard Error 0.22 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,093 (n=312, 138) | -0.01 10^3 c/uL | Standard Error 0.01 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,093 (n=312, 138) | -0.08 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,457 (n=292, 130) | -1.62 10^3 c/uL | Standard Error 0.25 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,457 (n=292, 130) | -1.68 10^3 c/uL | Standard Error 0.24 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,457 (n=292, 130) | 0.01 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,457 (n=292, 130) | -0.07 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,821 (n=262,124) | -1.71 10^3 c/uL | Standard Error 0.24 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,821 (n=262,124) | -1.92 10^3 c/uL | Standard Error 0.23 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,821 (n=262,124) | 0.01 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,821 (n=262,124) | -0.04 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,905 (n=134, 68) | -1.11 10^3 c/uL | Standard Error 0.32 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,905 (n=134, 68) | -1.53 10^3 c/uL | Standard Error 0.33 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,905 (n=134, 68) | -0.02 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,905 (n=134, 68) | 0.05 10^3 c/uL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 1,989 (n=121,56) | -0.97 10^3 c/uL | Standard Error 0.3 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 1,989 (n=121,56) | -1.47 10^3 c/uL | Standard Error 0.33 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 1,989 (n=121,56) | -0.00 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 1,989 (n=121,56) | 0.03 10^3 c/uL | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 2,073 (n=81,38) | -1.54 10^3 c/uL | Standard Error 0.44 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 2,073 (n=81,38) | -2.17 10^3 c/uL | Standard Error 0.47 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 2,073 (n=81,38) | 0.04 10^3 c/uL | Standard Error 0.02 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Monocytes Day 2,073 (n=81,38) | 0.11 10^3 c/uL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | White Blood Cells Day 2,185 (n=82,37) | -1.96 10^3 c/uL | Standard Error 0.39 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Neutrophils Day 2,185 (n=82,37) | -2.39 10^3 c/uL | Standard Error 0.43 |
| MTX + Placebo DB | Mean Change From BL in White Blood Cells in the OL Period | Absolute Eosinophils Day 2,185 (n=82,37) | -0.01 10^3 c/uL | Standard Error 0.02 |
Primary
Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Time frame: Day 169
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 | 288 Participants |
| MTX + Placebo DB | Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 | 85 Participants |
Comparison: The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.p-value: <0.00195% CI: [19.8, 36.7]Chi-squared, Corrected
Primary
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 | 270 Participants |
| MTX + Placebo DB | Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 | 84 Participants |
p-value: <0.00195% CI: [15.9, 32.9]Chi-squared, Corrected
Primary
Number of Participants Experiencing AEs of Special Interest in the OL Period
AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Experiencing AEs of Special Interest in the OL Period | Infections/Infestations | 452 Participants |
| ABA + MTX DB | Number of Participants Experiencing AEs of Special Interest in the OL Period | Neoplasms | 71 Participants |
| ABA + MTX DB | Number of Participants Experiencing AEs of Special Interest in the OL Period | Autoimmune Disorders | 52 Participants |
| ABA + MTX DB | Number of Participants Experiencing AEs of Special Interest in the OL Period | Acute Infusional AEs | 30 Participants |
| ABA + MTX DB | Number of Participants Experiencing AEs of Special Interest in the OL Period | Peri-Infusional AEs | 86 Participants |
Primary
Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.
Time frame: Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.
Population: All treated participants entering the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period | Body Temperature | 0 Participants |
| ABA + MTX DB | Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period | Heart Rate | 0 Participants |
| ABA + MTX DB | Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period | Blood Pressure | 0 Participants |
Primary
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | AEs | 518 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Deaths | 17 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | SAEs | 215 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Related SAEs | 60 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Discontinuations Due to SAEs | 36 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Related AEs | 323 Participants |
| ABA + MTX DB | Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period | Discontinued Due to AEs | 49 Participants |
Primary
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Sodium \< 0.9 \* LLN or \> 1.05 \* ULN or if BL \< LLN then use \< 0.95 \* BL or \> ULN or if BL \> ULN then use \>1.05 \*BL or \< LLN; Potassium: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \< 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Chloride: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \<0.9 \* BL or \>ULN or if BL \> ULN then use \> 1.1 \* BL or \< LLN; Calcium \<0.8 \* LLN or \> 1.2 \* ULN or if BL \< LLN then use \<0.67 \* BL or \> ULN or if BL \> ULN then use \> 1.3 \* BL or \< LLN.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Low Sodium (LLN 135 mmol/L) | 11 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | High Sodium (ULN 148 mmol/L) | 2 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Low Potassium (LLN 3.5 mmol/L) | 11 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | High Potassium (ULN 5.5 mmol/L) | 32 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Low Chloride (LLN 96 mmol/L) | 1 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | High Chloride (ULN 109 mmol/L) | 0 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Low Calcium (LLN 8.5 mg/dL) | 0 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | High Calcium (ULN 10.6 mg/dL) | 1 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | Low Phosphorous (LLN 2.5 mg/dL) | 16 Participants |
| ABA + MTX DB | Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period | High Phosphorous (ULN 5.6 mg/dL) | 8 Participants |
Primary
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
Glucose: \< 65 mg/dL or \> 220 mg/dL; Fasting Glucose: \<0.8 \* LLN or \> 1.5 \* ULN or if BL \< LLN then use \< 0.8 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Total protein: \< 0.9 \* LLN or 1.1 \* ULN or if BL \< LLN then use 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Albumin: \< 0.9 \* LLN or if BL \< LLN then use 0.75 \* BL; Uric acid: \> 1.5 \* ULN or if BL \> ULN then use \> 2.0 \* BL. All urinalysis abnormalities were defined as: if missing BL then use \>= 2 or if value \>=4, or if BL = 0 or 0.5 then use \>= 2, or if BL = 1.0 then use \>= 3, or if BL = 2.0 then use \>=4.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | Low Serum Glucose (LLN 64 mg/dL) | 120 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Serum Glucose (ULN 140 mg/dL) | 36 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | Low Serum Fasting Glucose (LLN 65 mg/dL) | 25 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Serum Fasting Glucose (ULN 109 mg/dL) | 22 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | Low Total Protein (LLN 6 g/dL) | 11 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Total Protein (ULN 8.5 g/dL) | 6 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | Low Albumin (LLN 3.5 g/dL) | 15 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Uric Acid (ULN 8.7 mg/dL) | 4 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Protein (ULN Trace) | 39 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Glucose (ULN Trace) | 39 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Ketones (ULN Positive) | 1 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Blood (ULN >=0) | 141 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Leukocyte Esterase (ULN >=0) | 35 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine White Blood Count (ULN 12 hpf) | 232 Participants |
| ABA + MTX DB | Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period | High Urine Red Blood Count (ULN 8 hpf) | 181 Participants |
Primary
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Hemoglobin (LLN 11.5 g/dL) | 21 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Hematocrit (LLN 34%) | 20 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Erythrocytes (LLN 38 x 10^6 c/µL) | 15 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Platelet Count (LLN 140 x 10^3 c/µL) | 9 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Platelet Count (ULN 415 x 10^3 c/µL) | 4 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Leukocytes (LLN 4 x 10^3 c/µL) | 53 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Leukocytes (ULN 10.5 x 10^3 c/µL) | 68 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Absolute Neutrophils (LLN 1.8 x 10^3 c/µL) | 14 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | Low Absolute Lymphocytes (LLN 0.7 x 10^3 c/µL) | 109 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Absolute Lymphocytes (ULN 4.5 x 10^3 c/µL) | 4 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Absolute Monocytes (ULN 1.0 x 10^3 c/µL) | 9 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Absolute Basophils (ULN 0.2 x 10^3 c/µL) | 3 Participants |
| ABA + MTX DB | Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period | High Absolute Eosinophils (ULN 0.4 x 10^3 c/µL) | 49 Participants |
Primary
Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period
Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.
Time frame: Day 1 to Day 1,821
Population: Participants with serum samples available for evaluation of titers to abatacept.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period | 56 Participants |
Primary
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Time frame: Day 365 to Day 2,185
Population: All treated participants in the OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High ALP (ULN 150 U/L) | 3 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High AST (ULN 40 U/L) | 14 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High ALT (ULN 55 U/L) | 20 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High GGT (ULN 65 U/L) | 36 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High Bilirubin (ULN 1.2 mg/dL) | 6 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High BUN (ULN 26 mg/dL) | 40 Participants |
| ABA + MTX DB | Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period | High Creatinine (ULN 1.5 mg/dL) | 92 Participants |
Secondary
ACR 20 Responders at Day 365
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Time frame: Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | ACR 20 Responders at Day 365 | 310 Participants |
| MTX + Placebo DB | ACR 20 Responders at Day 365 | 85 Participants |
p-value: <0.00195% CI: [25.1, 41.7]Chi-squared, Corrected
Secondary
ACR 20 Responders in the Double-Blind (DB) Period
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 113 | 283 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 169 | 288 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 141 | 291 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 29 | 155 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 225 | 318 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 85 | 262 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 281 | 312 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 57 | 237 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 365 | 310 Participants |
| ABA + MTX DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 15 | 97 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 365 | 85 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 169 | 85 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 15 | 30 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 29 | 51 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 85 | 80 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 113 | 86 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 141 | 93 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 225 | 91 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 281 | 94 Participants |
| MTX + Placebo DB | ACR 20 Responders in the Double-Blind (DB) Period | Day 57 | 75 Participants |
Secondary
ACR 50 Responders at Day 169
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Time frame: Day 169
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | ACR 50 Responders at Day 169 | 169 Participants |
| MTX + Placebo DB | ACR 50 Responders at Day 169 | 36 Participants |
p-value: <0.00195% CI: [15, 31.1]Chi-squared, Corrected
Secondary
ACR 50 Responders at Day 365
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | ACR 50 Responders at Day 365 | 205 Participants |
| MTX + Placebo DB | ACR 50 Responders at Day 365 | 39 Participants |
p-value: <0.00195% CI: [21.8, 38.5]Chi-squared, Corrected
Secondary
ACR 50 Responders in the DB Period
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 141 | 162 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 57 | 87 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 169 | 169 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 85 | 135 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 225 | 197 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 29 | 36 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 281 | 200 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 113 | 148 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 365 | 205 Participants |
| ABA + MTX DB | ACR 50 Responders in the DB Period | Day 15 | 12 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 365 | 39 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 15 | 2 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 29 | 9 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 85 | 17 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 113 | 27 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 141 | 39 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 169 | 36 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 225 | 42 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 281 | 38 Participants |
| MTX + Placebo DB | ACR 50 Responders in the DB Period | Day 57 | 16 Participants |
Secondary
ACR 70 Responders at Day 169
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 169
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | ACR 70 Responders at Day 169 | 84 Participants |
| MTX + Placebo DB | ACR 70 Responders at Day 169 | 14 Participants |
p-value: <0.00195% CI: [7, 19.5]Chi-squared, Corrected
Secondary
ACR 70 Responders at Day 365
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | ACR 70 Responders at Day 365 | 122 Participants |
| MTX + Placebo DB | ACR 70 Responders at Day 365 | 13 Participants |
p-value: <0.00195% CI: [15.6, 29.8]Chi-squared, Corrected
Secondary
ACR 70 Responders in the DB Period
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 15 | 4 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 29 | 8 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 57 | 27 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 85 | 54 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 113 | 57 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 141 | 75 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 169 | 84 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 225 | 103 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 281 | 106 Participants |
| ABA + MTX DB | ACR 70 Responders in the DB Period | Day 365 | 122 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 225 | 16 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 15 | 1 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 141 | 12 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 29 | 2 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 365 | 13 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 57 | 6 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 169 | 14 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 85 | 7 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 281 | 19 Participants |
| MTX + Placebo DB | ACR 70 Responders in the DB Period | Day 113 | 12 Participants |
Secondary
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 15 (n=401, 199) | 3.27 IU / mL | Standard Deviation 3.13 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 29 (n=410, 208) | 1.94 IU / mL | Standard Deviation 1.99 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 57 (n=416, 209) | 1.70 IU / mL | Standard Deviation 2.02 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 85 (n=412, 203) | 1.53 IU / mL | Standard Deviation 1.97 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 113 (n=417, 209) | 1.49 IU / mL | Standard Deviation 1.69 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 141 (n=414, 209) | 1.27 IU / mL | Standard Deviation 1.52 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 169 (n=420, 211) | 1.42 IU / mL | Standard Deviation 1.67 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 225 (n=414, 212) | 1.30 IU / mL | Standard Deviation 1.55 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 281 (n=412, 210) | 1.36 IU / mL | Standard Deviation 1.8 |
| ABA + MTX DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 1.27 IU / mL | Standard Deviation 1.63 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 225 (n=414, 212) | 2.46 IU / mL | Standard Deviation 2.7 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 15 (n=401, 199) | 2.65 IU / mL | Standard Deviation 2.34 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 141 (n=414, 209) | 2.48 IU / mL | Standard Deviation 2.61 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 29 (n=410, 208) | 2.65 IU / mL | Standard Deviation 2.48 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 2.41 IU / mL | Standard Deviation 2.58 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 57 (n=416, 209) | 2.36 IU / mL | Standard Deviation 2.34 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 169 (n=420, 211) | 2.56 IU / mL | Standard Deviation 2.43 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 85 (n=412, 203) | 2.53 IU / mL | Standard Deviation 2.39 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 281 (n=412, 210) | 2.60 IU / mL | Standard Deviation 3.09 |
| MTX + Placebo DB | ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period | Day 113 (n=417, 209) | 2.55 IU / mL | Standard Deviation 2.59 |
Secondary
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 15 Cohort (n=416, 210) | 16.40 joints | Standard Deviation 8.63 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 29 Cohort (n=419, 211) | 14.04 joints | Standard Deviation 9.26 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 57 Cohort (n=421, 210) | 11.02 joints | Standard Deviation 8.64 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 85 Cohort (n=417, 208) | 9.76 joints | Standard Deviation 8.99 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 113 Cohort (n=415, 210) | 8.73 joints | Standard Deviation 8.64 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 141 Cohort (n=420, 211) | 7.84 joints | Standard Deviation 8.1 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 169 Cohort (n=420, 211) | 7.54 joints | Standard Deviation 7.77 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 225 Cohort (n=419, 212) | 6.80 joints | Standard Deviation 7.57 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 281 Cohort (n=419, 211) | 6.50 joints | Standard Deviation 7.52 |
| ABA + MTX DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 365 Cohort (n=424, 212) | 6.31 joints | Standard Deviation 7.16 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 225 Cohort (n=419, 212) | 12.78 joints | Standard Deviation 11.06 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 15 Cohort (n=416, 210) | 18.49 joints | Standard Deviation 9.92 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 141 Cohort (n=420, 211) | 13.28 joints | Standard Deviation 10.7 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 29 Cohort (n=419, 211) | 16.03 joints | Standard Deviation 9.23 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 365 Cohort (n=424, 212) | 12.69 joints | Standard Deviation 10.84 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 57 Cohort (n=421, 210) | 14.77 joints | Standard Deviation 9.85 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 169 Cohort (n=420, 211) | 13.14 joints | Standard Deviation 11.05 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 85 Cohort (n=417, 208) | 14.56 joints | Standard Deviation 10.83 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 281 Cohort (n=419, 211) | 12.46 joints | Standard Deviation 10.98 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 113 Cohort (n=415, 210) | 13.93 joints | Standard Deviation 10.69 |
Secondary
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 15 Cohort (n=416, 210) | 25.19 Joints | Standard Deviation 14.62 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 29 Cohort (n=419, 211) | 21.14 Joints | Standard Deviation 14.69 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 57 Cohort (n=421, 210) | 16.70 Joints | Standard Deviation 14.06 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 85 Cohort (n=417, 208) | 14.84 Joints | Standard Deviation 13.98 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 113 Cohort (n=415, 210) | 13.55 Joints | Standard Deviation 13.35 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 141 Cohort (n=420, 211) | 12.59 Joints | Standard Deviation 13.39 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 169 Cohort (n=420, 211) | 11.69 Joints | Standard Deviation 12.37 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 225 Cohort (n=419, 212) | 10.42 Joints | Standard Deviation 12.04 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 281Cohort (n=419, 211) | 9.92 Joints | Standard Deviation 11.37 |
| ABA + MTX DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 365 Cohort (n=424, 212) | 9.96 Joints | Standard Deviation 11.87 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 225 Cohort (n=419, 212) | 18.22 Joints | Standard Deviation 15.46 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 15 Cohort (n=416, 210) | 27.93 Joints | Standard Deviation 14.27 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 141 Cohort (n=420, 211) | 19.78 Joints | Standard Deviation 15.74 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 29 Cohort (n=419, 211) | 24.11 Joints | Standard Deviation 14.97 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 365 Cohort (n=424, 212) | 18.31 Joints | Standard Deviation 15.72 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 57 Cohort (n=421, 210) | 21.41 Joints | Standard Deviation 14.15 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 169 Cohort (n=420, 211) | 18.70 Joints | Standard Deviation 15.42 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 85 Cohort (n=417, 208) | 20.58 Joints | Standard Deviation 15.61 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 281Cohort (n=419, 211) | 17.10 Joints | Standard Deviation 16.04 |
| MTX + Placebo DB | ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period | BL (Day 0) for Day 113 Cohort (n=415, 210) | 19.83 Joints | Standard Deviation 15.29 |
Secondary
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 15 (n=413, 210) | 50.90 Units on a Scale | Standard Deviation 22.42 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 45.26 Units on a Scale | Standard Deviation 22.72 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 57 (n=419, 209) | 39.78 Units on a Scale | Standard Deviation 23.02 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 85 (n=417, 207) | 35.07 Units on a Scale | Standard Deviation 23.37 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 113 (n=418, 210) | 33.98 Units on a Scale | Standard Deviation 22.59 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 33.52 Units on a Scale | Standard Deviation 24.06 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 32.37 Units on a Scale | Standard Deviation 23.26 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 210) | 30.63 Units on a Scale | Standard Deviation 22.48 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 211) | 29.98 Units on a Scale | Standard Deviation 23.25 |
| ABA + MTX DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 28.95 Units on a Scale | Standard Deviation 23.6 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 210) | 46.06 Units on a Scale | Standard Deviation 26.21 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 15 (n=413, 210) | 56.66 Units on a Scale | Standard Deviation 22.33 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 47.52 Units on a Scale | Standard Deviation 26.57 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 53.11 Units on a Scale | Standard Deviation 22.81 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 45.62 Units on a Scale | Standard Deviation 26.92 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 57 (n=419, 209) | 49.34 Units on a Scale | Standard Deviation 23.98 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 47.93 Units on a Scale | Standard Deviation 26.24 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 85 (n=417, 207) | 46.82 Units on a Scale | Standard Deviation 24.71 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 211) | 44.45 Units on a Scale | Standard Deviation 26.13 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period | Day 113 (n=418, 210) | 47.26 Units on a Scale | Standard Deviation 25.69 |
Secondary
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 15 (n=413, 210) | 52.39 Units on a Scale | Standard Deviation 22.85 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 47.03 Units on a Scale | Standard Deviation 23.84 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 57 (n=419, 209) | 40.34 Units on a Scale | Standard Deviation 24.29 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 85 (n=417, 207) | 35.97 Units on a Scale | Standard Deviation 24.01 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 113 (n=418, 210) | 34.31 Units on a Scale | Standard Deviation 23.61 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 33.93 Units on a Scale | Standard Deviation 25.47 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 32.69 Units on a Scale | Standard Deviation 24.32 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 211) | 31.39 Units on a Scale | Standard Deviation 24.01 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 210) | 31.06 Units on a Scale | Standard Deviation 24.58 |
| ABA + MTX DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 29.78 Units on a Scale | Standard Deviation 24.2 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 211) | 47.20 Units on a Scale | Standard Deviation 26.77 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 15 (n=413, 210) | 60.08 Units on a Scale | Standard Deviation 21.9 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 48.26 Units on a Scale | Standard Deviation 27.19 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 54.69 Units on a Scale | Standard Deviation 23.86 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 48.17 Units on a Scale | Standard Deviation 27.82 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 57 (n=419, 209) | 50.11 Units on a Scale | Standard Deviation 25.16 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 49.21 Units on a Scale | Standard Deviation 27.13 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 85 (n=417, 207) | 48.36 Units on a Scale | Standard Deviation 25.53 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 210) | 46.18 Units on a Scale | Standard Deviation 27.23 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period | Day 113 (n=418, 210) | 48.60 Units on a Scale | Standard Deviation 26.99 |
Secondary
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 57 (n=412, 205) | 1.29 Units on a Scale | Standard Deviation 0.65 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 141 (n=411, 207) | 1.13 Units on a Scale | Standard Deviation 0.71 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 29 (n=406, 207) | 1.41 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 169 (n=413, 207) | 1.11 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 225 (n=409, 207) | 1.06 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 85 (n=407, 203) | 1.18 Units on a Scale | Standard Deviation 0.68 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 281 (n=408, 207) | 1.05 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 15 (n=405, 206) | 1.51 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 365 (n=415, 208) | 1.04 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 113 (n=409, 206) | 1.16 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 365 (n=415, 208) | 1.34 Units on a Scale | Standard Deviation 0.7 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 15 (n=405, 206) | 1.58 Units on a Scale | Standard Deviation 0.56 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 29 (n=406, 207) | 1.47 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 57 (n=412, 205) | 1.42 Units on a Scale | Standard Deviation 0.63 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 85 (n=407, 203) | 1.32 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 113 (n=409, 206) | 1.35 Units on a Scale | Standard Deviation 0.68 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 141 (n=411, 207) | 1.35 Units on a Scale | Standard Deviation 0.7 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 225 (n=409, 207) | 1.35 Units on a Scale | Standard Deviation 0.7 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 281 (n=408, 207) | 1.31 Units on a Scale | Standard Deviation 0.68 |
| MTX + Placebo DB | ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period | Day 169 (n=413, 207) | 1.31 Units on a Scale | Standard Deviation 0.69 |
Secondary
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 210) | 23.33 Units on a Scale | Standard Deviation 19.09 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 15 (n=415, 209) | 52.79 Units on a Scale | Standard Deviation 19.24 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 45.24 Units on a Scale | Standard Deviation 20.58 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 57 (n=421, 210) | 35.89 Units on a Scale | Standard Deviation 19.84 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 85 (n=416, 208) | 31.07 Units on a Scale | Standard Deviation 20.12 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 113 (n=412, 209) | 29.01 Units on a Scale | Standard Deviation 20.4 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 26.71 Units on a Scale | Standard Deviation 20.38 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 25.44 Units on a Scale | Standard Deviation 19.65 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 212) | 24.34 Units on a Scale | Standard Deviation 19.27 |
| ABA + MTX DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 21.58 Units on a Scale | Standard Deviation 19.53 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 169 (n=421, 211) | 41.75 Units on a Scale | Standard Deviation 25.79 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 281 (n=419, 210) | 38.76 Units on a Scale | Standard Deviation 26.7 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 113 (n=412, 209) | 42.20 Units on a Scale | Standard Deviation 24.72 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 15 (n=415, 209) | 56.68 Units on a Scale | Standard Deviation 18.93 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 365 (n=424, 212) | 41.04 Units on a Scale | Standard Deviation 25.91 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 29 (n=418, 211) | 51.83 Units on a Scale | Standard Deviation 20.14 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 141 (n=420, 211) | 41.22 Units on a Scale | Standard Deviation 25.33 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 57 (n=421, 210) | 45.21 Units on a Scale | Standard Deviation 22.61 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 225 (n=418, 212) | 40.68 Units on a Scale | Standard Deviation 26.15 |
| MTX + Placebo DB | ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period | Day 85 (n=416, 208) | 42.59 Units on a Scale | Standard Deviation 23.87 |
Secondary
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Time frame: BL (Day 0), Day 169, Day 365
Population: Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 CRP Day 169 (n=418, 211) | -2.38 mg / mL | Standard Error 0.06 |
| ABA + MTX DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 ESR Day 169 (n=418, 211) | -2.48 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 CRP Day 365 (n=424, 212) | -2.71 mg / mL | Standard Error 0.06 |
| ABA + MTX DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 ESR Day 365 (n=424, 212) | -2.85 mg / mL | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 ESR Day 365 (n=424, 212) | -1.46 mg / mL | Standard Error 0.1 |
| MTX + Placebo DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 CRP Day 169 (n=418, 211) | -1.29 mg / mL | Standard Error 0.09 |
| MTX + Placebo DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 CRP Day 365 (n=424, 212) | -1.41 mg / mL | Standard Error 0.09 |
| MTX + Placebo DB | Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period | DAS-28 ESR Day 169 (n=418, 211) | -1.33 mg / mL | Standard Error 0.1 |
Secondary
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: Day 169
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Dressing and Grooming | -0.73 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Hygiene | -0.48 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Eating | -0.68 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Reaching | -0.64 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Arising | -0.69 Units on a Scale | Standard Error 0.03 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Gripping | -0.53 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Walking | -0.58 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Activities | -0.57 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | HAQ DI | -0.62 Units on a Scale | Standard Error 0.03 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Activities | -0.43 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | HAQ DI | -0.52 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Dressing and Grooming | -0.55 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Arising | -0.65 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Eating | -0.48 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Walking | -0.45 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Hygiene | -0.40 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Reaching | -0.52 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 | Gripping | -0.43 Units on a Scale | Standard Error 0.06 |
Secondary
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Arising | -0.75 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Hygiene | -0.53 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Dressing and Grooming | -0.78 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Reaching | -0.70 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Eating | -0.81 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Gripping | -0.65 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | HAQ DI | -0.68 Units on a Scale | Standard Error 0.03 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Activities | -0.66 Units on a Scale | Standard Error 0.44 |
| ABA + MTX DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Walking | -0.61 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Activities | -0.47 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Dressing and Grooming | -0.61 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Arising | -0.58 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Eating | -0.44 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Walking | -0.50 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Hygiene | -0.37 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Reaching | -0.59 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | Gripping | -0.44 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 | HAQ DI | -0.51 Units on a Scale | Standard Error 0.06 |
Secondary
Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period | Day 169 (n=416, 207) | 8.82 Units on a Scale | Standard Error 0.42 |
| ABA + MTX DB | Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period | Day 365 (n=417, 207) | 9.12 Units on a Scale | Standard Error 0.43 |
| MTX + Placebo DB | Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period | Day 169 (n=416, 207) | 4.77 Units on a Scale | Standard Error 0.59 |
| MTX + Placebo DB | Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period | Day 365 (n=417, 207) | 4.97 Units on a Scale | Standard Error 0.61 |
Comparison: Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.p-value: <0.00195% CI: [2.64, 5.57]ANCOVA
Comparison: Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.p-value: <0.00195% CI: [2.69, 5.62]ANCOVA
Secondary
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort JSN (n=233, 114) | 10.77 Units on a Scale | Standard Deviation 13.73 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 TS Change From BL (n=291, 131) | 0.80 Units on a Scale | Standard Deviation 1.99 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 JSN Change From BL (n=233, 114) | 0.90 Units on a Scale | Standard Deviation 2.54 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort Erosion (n=290, 130) | 17.40 Units on a Scale | Standard Deviation 15.41 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort TS (n=290, 128) | 28.12 Units on a Scale | Standard Deviation 28.35 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 Erosion Change From BL (n=291, 131) | 0.59 Units on a Scale | Standard Deviation 1.67 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort TS (n=233, 114) | 28.39 Units on a Scale | Standard Deviation 28.5 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort JSN (n=291, 131) | 10.65 Units on a Scale | Standard Deviation 13.8 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 TS Change From BL (n=233, 114) | 2.02 Units on a Scale | Standard Deviation 4.93 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 JSN Change From BL(n=291, 131) | 0.55 Units on a Scale | Standard Deviation 1.4 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort Erosion (n=233,114) | 17.62 Units on a Scale | Standard Deviation 15.62 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort TS (n=291, 131) | 28.05 Units on a Scale | Standard Deviation 28.41 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort Erosion (n=291, 131) | 17.65 Units on a Scale | Standard Deviation 15.81 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 TS Change From BL(n=291, 131) | 1.14 Units on a Scale | Standard Deviation 2.69 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 JSN Change From BL (n=290, 128) | 0.85 Units on a Scale | Standard Deviation 2.3 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort Erosion (n=293,130) | 17.66 Units on a Scale | Standard Deviation 15.78 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 Erosion Change From BL (n=291, 131) | 0.42 Units on a Scale | Standard Deviation 1.2 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 Erosion Change From BL (n=293, 130) | 0.92 Units on a Scale | Standard Deviation 2.6 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 Erosion Change From BL (n=233, 114) | 1.12 Units on a Scale | Standard Deviation 2.99 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort JSN (n=293, 130) | 10.84 Units on a Scale | Standard Deviation 13.97 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 JSN Change From BL (n=293, 130) | 0.73 Units on a Scale | Standard Deviation 2.02 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort TS (n=293, 130) | 28.50 Units on a Scale | Standard Deviation 28.94 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort JSN (n=291, 131) | 10.83 Units on a Scale | Standard Deviation 14.02 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 Total Score Change From BL (n=293, 130) | 1.65 Units on a Scale | Standard Deviation 4.2 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 TS Change From BL (n=290, 128) | 2.01 Units on a Scale | Standard Deviation 5 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort Erosion (n=290,128) | 17.46 Units on a Scale | Standard Deviation 15.46 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 JSN Change From BL(n=291, 131) | 0.38 Units on a Scale | Standard Deviation 1.05 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 Erosion Change From BL (n=290, 128) | 1.16 Units on a Scale | Standard Deviation 3.14 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort TS (n=291, 131) | 28.48 Units on a Scale | Standard Deviation 29.01 |
| ABA + MTX DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort JSN (n=290, 128) | 10.66 Units on a Scale | Standard Deviation 13.71 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort TS (n=291, 131) | 30.71 Units on a Scale | Standard Deviation 30.84 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort JSN (n=293, 130) | 12.02 Units on a Scale | Standard Deviation 14.53 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 JSN Change From BL (n=293, 130) | 1.31 Units on a Scale | Standard Deviation 3.4 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort JSN (n=233, 114) | 12.01 Units on a Scale | Standard Deviation 14.47 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort TS (n=233, 114) | 30.94 Units on a Scale | Standard Deviation 30.99 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort JSN (n=290, 128) | 12.12 Units on a Scale | Standard Deviation 14.64 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 JSN Change From BL (n=290, 128) | 1.51 Units on a Scale | Standard Deviation 3.73 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort TS (n=290, 128) | 31.06 Units on a Scale | Standard Deviation 31.16 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 TS Change From BL (n=290, 128) | 3.27 Units on a Scale | Standard Deviation 7.55 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1821 Cohort Erosion (n=233,114) | 18.93 Units on a Scale | Standard Deviation 17.37 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 Erosion Change From BL (n=233, 114) | 2.05 Units on a Scale | Standard Deviation 4.88 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 JSN Change From BL (n=233, 114) | 1.73 Units on a Scale | Standard Deviation 4.11 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1821 TS Change From BL (n=233, 114) | 3.78 Units on a Scale | Standard Deviation 8.46 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort Erosion (n=291, 131) | 18.69 Units on a Scale | Standard Deviation 17.12 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 Erosion Change From BL (n=291, 131) | 0.84 Units on a Scale | Standard Deviation 1.93 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 365 Cohort JSN (n=291, 131) | 12.02 Units on a Scale | Standard Deviation 14.53 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 JSN Change From BL(n=291, 131) | 0.64 Units on a Scale | Standard Deviation 1.67 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 365 TS Change From BL (n=291, 131) | 1.48 Units on a Scale | Standard Deviation 3.35 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort Erosion (n=290, 130) | 18.88 Units on a Scale | Standard Deviation 17.18 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 Erosion Change From BL (n=291, 131) | 1.14 Units on a Scale | Standard Deviation 2.74 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort JSN (n=291, 131) | 12.21 Units on a Scale | Standard Deviation 14.56 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 JSN Change From BL(n=291, 131) | 1.05 Units on a Scale | Standard Deviation 2.79 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 729 Cohort TS (n=291, 131) | 31.09 Units on a Scale | Standard Deviation 30.93 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 729 TS Change From BL(n=291, 131) | 2.19 Units on a Scale | Standard Deviation 5.22 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort Erosion (n=293,130) | 18.69 Units on a Scale | Standard Deviation 17.12 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 Erosion Change From BL (n=293, 130) | 1.48 Units on a Scale | Standard Deviation 3.65 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1093 Cohort TS (n=293, 130) | 30.71 Units on a Scale | Standard Deviation 30.84 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1093 Total Score Change From BL (n=293, 130) | 2.79 Units on a Scale | Standard Deviation 6.6 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | BL (Day 0) for Day 1457 Cohort Erosion (n=290,128) | 18.94 Units on a Scale | Standard Deviation 17.3 |
| MTX + Placebo DB | BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period | Day 1457 Erosion Change From BL (n=290, 128) | 1.76 Units on a Scale | Standard Deviation 4.3 |
Secondary
BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period
This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
Time frame: BL (Day 365)
Population: All treated participants in the OL period (treatment groups represent treatment received in the DB period).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period | RF Negative | 42 Participants |
| ABA + MTX DB | BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period | RF Positive | 312 Participants |
| MTX + Placebo DB | BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period | RF Negative | 18 Participants |
| MTX + Placebo DB | BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period | RF Positive | 130 Participants |
Secondary
Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.
Time frame: BL (Day 0), Day 365
Population: This analysis was not completed.
Secondary
Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365
The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\>5.1); low (≤3.2); remission (\<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365, Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 169 Cohort (n=366, 179) | 6.82 Units on a Scale | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 169 Cohort (n=366, 179) | 4.34 Units on a Scale | Standard Deviation 1.38 |
| ABA + MTX DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 365 Cohort (n=375, 183) | 6.82 Units on a Scale | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 365 Cohort (n=375, 183) | 3.97 Units on a Scale | Standard Deviation 1.4 |
| MTX + Placebo DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 365 Cohort (n=375, 183) | 5.36 Units on a Scale | Standard Deviation 1.32 |
| MTX + Placebo DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 169 Cohort (n=366, 179) | 6.84 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 365 Cohort (n=375, 183) | 6.83 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 | BL (Day 0) for Day 169 Cohort (n=366, 179) | 5.50 Units on a Scale | Standard Deviation 1.35 |
p-value: <0.00195% CI: [-1.38, -0.91]ANCOVA
p-value: <0.00195% CI: [-1.63, -1.16]ANCOVA
Secondary
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 32.95 Units on a Scale | Standard Deviation 7.36 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 134) | 32.81 Units on a Scale | Standard Deviation 7.5 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 32.80 Units on a Scale | Standard Deviation 7.27 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 32.57 Units on a Scale | Standard Deviation 7.37 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 33.00 Units on a Scale | Standard Deviation 7.3 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 32.73 Units on a Scale | Standard Deviation 7.35 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 32.80 Units on a Scale | Standard Deviation 7.33 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 32.78 Units on a Scale | Standard Deviation 7.36 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 33.05 Units on a Scale | Standard Deviation 7.36 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 32.85 Units on a Scale | Standard Deviation 7.44 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 32.79 Units on a Scale | Standard Deviation 7.28 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 32.94 Units on a Scale | Standard Deviation 7.38 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 31.49 Units on a Scale | Standard Deviation 6.81 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 138) | 32.88 Units on a Scale | Standard Deviation 7.3 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 33.13 Units on a Scale | Standard Deviation 7.37 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 32.84 Units on a Scale | Standard Deviation 7.34 |
| ABA + MTX DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 31.98 Units on a Scale | Standard Deviation 7.2 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 33.13 Units on a Scale | Standard Deviation 7.71 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 33.47 Units on a Scale | Standard Deviation 7.56 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 33.27 Units on a Scale | Standard Deviation 7.49 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 33.49 Units on a Scale | Standard Deviation 7.59 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 33.44 Units on a Scale | Standard Deviation 7.57 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 33.53 Units on a Scale | Standard Deviation 7.65 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 33.29 Units on a Scale | Standard Deviation 7.67 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 33.29 Units on a Scale | Standard Deviation 7.74 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 33.43 Units on a Scale | Standard Deviation 7.53 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 134) | 33.31 Units on a Scale | Standard Deviation 7.77 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 31.83 Units on a Scale | Standard Deviation 6.61 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 33.48 Units on a Scale | Standard Deviation 7.74 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 33.20 Units on a Scale | Standard Deviation 7.52 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 33.56 Units on a Scale | Standard Deviation 7.71 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 32.81 Units on a Scale | Standard Deviation 7.66 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 31.40 Units on a Scale | Standard Deviation 5.91 |
| MTX + Placebo DB | Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 138) | 33.29 Units on a Scale | Standard Deviation 7.71 |
Secondary
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) CRP for Day 169 Cohort (n=418, 211) | 6.37 mg / mL | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) CRP for Day 365 Cohort (n=424, 212) | 6.38 mg / mL | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) ESR for Day 169 Cohort (n=418, 211) | 6.82 mg / mL | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) ESR for Day 365 Cohort (n=424, 212) | 6.82 mg / mL | Standard Deviation 0.87 |
| MTX + Placebo DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) ESR for Day 169 Cohort (n=418, 211) | 6.84 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) CRP for Day 169 Cohort (n=418, 211) | 6.36 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) ESR for Day 365 Cohort (n=424, 212) | 6.83 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period | BL (Day 0) CRP for Day 365 Cohort (n=424, 212) | 6.35 mg / mL | Standard Deviation 0.82 |
Secondary
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 57 Cohort (n=362, 153) | 6.36 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 729 Cohort (n=333, 145) | 6.37 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 225 Cohort (n=361, 155) | 6.35 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 813 Cohort (n=313, 140) | 6.39 mg / mL | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 113 Cohort (n=362, 149) | 6.35 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 897 Cohort (n=301, 133) | 6.38 mg / mL | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 281 Cohort (n=359, 156) | 6.35 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 981 Cohort (n=294, 131) | 6.39 mg / mL | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 29 Cohort (n=357, 154) | 6.36 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=296, 127) | 6.37 mg / mL | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 365 Cohort (n=365, 156) | 6.36 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=156, 70) | 6.43 mg / mL | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 141 Cohort (n=361, 155) | 6.34 mg / mL | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=267, 117) | 6.39 mg / mL | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 449 Cohort (n=352, 147) | 6.37 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=281, 126) | 6.40 mg / mL | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 85 Cohort (n=362, 149) | 6.35 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=269, 121) | 6.39 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 533 Cohort (n=338, 147) | 6.38 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=267, 122) | 6.39 mg / mL | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 169 Cohort (n=366, 156) | 6.35 mg / mL | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 53) | 6.53 mg / mL | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 617 Cohort (n=329, 150) | 6.37 mg / mL | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=82, 36) | 6.41 mg / mL | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 15 Cohort (n=352, 150) | 6.36 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=82, 36) | 6.38 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 15 Cohort (n=352, 150) | 6.32 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 29 Cohort (n=357, 154) | 6.35 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 57 Cohort (n=362, 153) | 6.35 mg / mL | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 85 Cohort (n=362, 149) | 6.33 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 113 Cohort (n=362, 149) | 6.34 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 141 Cohort (n=361, 155) | 6.33 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 169 Cohort (n=366, 156) | 6.34 mg / mL | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 225 Cohort (n=361, 155) | 6.33 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 281 Cohort (n=359, 156) | 6.33 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 365 Cohort (n=365, 156) | 6.33 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 449 Cohort (n=352, 147) | 6.34 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 533 Cohort (n=338, 147) | 6.35 mg / mL | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 617 Cohort (n=329, 150) | 6.35 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 729 Cohort (n=333, 145) | 6.36 mg / mL | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 813 Cohort (n=313, 140) | 6.37 mg / mL | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 897 Cohort (n=301, 133) | 6.37 mg / mL | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 981 Cohort (n=294, 131) | 6.37 mg / mL | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=296, 127) | 6.37 mg / mL | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=156, 70) | 6.38 mg / mL | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=267, 117) | 6.34 mg / mL | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=281, 126) | 6.35 mg / mL | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=269, 121) | 6.40 mg / mL | Standard Deviation 0.77 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=267, 122) | 6.33 mg / mL | Standard Deviation 0.76 |
| MTX + Placebo DB | Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 53) | 6.49 mg / mL | Standard Deviation 0.75 |
Secondary
Mean BL DAS-28 ESR Over Time in the OL Period
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=287, 130) | 6.83 IU / mL | Standard Deviation 0.88 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 729 Cohort (n=315, 139) | 6.82 IU / mL | Standard Deviation 0.88 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=241, 110) | 6.86 IU / mL | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 533 Cohort (n=332, 146) | 6.83 IU / mL | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=271, 121) | 6.82 IU / mL | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 813 Cohort (n=303, 134) | 6.82 IU / mL | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=269, 117) | 6.87 IU / mL | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 365 Cohort (n=352, 148) | 6.82 IU / mL | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=260, 118) | 6.86 IU / mL | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 897 Cohort (n=296, 128) | 6.83 IU / mL | Standard Deviation 0.88 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=259, 114) | 6.85 IU / mL | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 617 Cohort (n=325, 148) | 6.85 IU / mL | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=108, 47) | 6.95 IU / mL | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 981 Cohort (n=282, 119) | 6.82 IU / mL | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=76, 31) | 6.90 IU / mL | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 449 Cohort (n=345, 145) | 6.82 IU / mL | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=76, 31) | 6.97 IU / mL | Standard Deviation 0.92 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 449 Cohort (n=345, 145) | 6.89 IU / mL | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 533 Cohort (n=332, 146) | 6.88 IU / mL | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 617 Cohort (n=325, 148) | 6.86 IU / mL | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 729 Cohort (n=315, 139) | 6.87 IU / mL | Standard Deviation 0.88 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 813 Cohort (n=303, 134) | 6.90 IU / mL | Standard Deviation 0.88 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 897 Cohort (n=296, 128) | 6.85 IU / mL | Standard Deviation 0.9 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 981 Cohort (n=282, 119) | 6.88 IU / mL | Standard Deviation 0.88 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=287, 130) | 6.87 IU / mL | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=241, 110) | 6.89 IU / mL | Standard Deviation 0.92 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=271, 121) | 6.86 IU / mL | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=269, 117) | 6.88 IU / mL | Standard Deviation 0.87 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=260, 118) | 6.86 IU / mL | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=259, 114) | 6.87 IU / mL | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=108, 47) | 7.04 IU / mL | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL DAS-28 ESR Over Time in the OL Period | BL (Day 0) for Day 365 Cohort (n=352, 148) | 6.88 IU / mL | Standard Deviation 0.85 |
Secondary
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) E-Selectin for D169 Cohort (n= 256,126) | 85.89 ng / mL | Standard Error 72.62 |
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) SICAM-1 for D169 Cohort (n=264, 130) | 444.0 ng / mL | Standard Error 398.1 |
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) MMP3 for D169 Cohort (n=362, 183) | 83.37 ng / mL | Standard Error 81.53 |
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) E-Selectin fpr D365 Cohort (n=162, 74) | 85.91 ng / mL | Standard Error 71.66 |
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) SICAM-1 for D365 Cohort (n=235, 114) | 467.2 ng / mL | Standard Error 578.5 |
| ABA + MTX DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) MMP3 for D365 Cohort (n=232, 112) | 79.56 ng / mL | Standard Error 78.35 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) SICAM-1 for D365 Cohort (n=235, 114) | 449.5 ng / mL | Standard Error 356 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) E-Selectin for D169 Cohort (n= 256,126) | 85.53 ng / mL | Standard Error 68.42 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) E-Selectin fpr D365 Cohort (n=162, 74) | 88.39 ng / mL | Standard Error 75.09 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) SICAM-1 for D169 Cohort (n=264, 130) | 426.8 ng / mL | Standard Error 323.5 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) MMP3 for D365 Cohort (n=232, 112) | 64.02 ng / mL | Standard Error 59.05 |
| MTX + Placebo DB | Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period | BL (Day 0) MMP3 for D169 Cohort (n=362, 183) | 77.22 ng / mL | Standard Error 73.72 |
Secondary
Mean BL ESR and CRP Levels in the OL Period
Mean baseline values are reported for each cohort at each time point.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 2,185 (n=83, 38) | 34.73 IU / mL | Standard Deviation 36.05 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,093 (n=283, 123) | 43.57 IU / mL | Standard Deviation 23.34 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,457 (n=270, 111) | 43.49 IU / mL | Standard Deviation 23.71 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,093 (n=306, 131) | 31.96 IU / mL | Standard Deviation 30.35 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 365 (n=373, 160) | 32.48 IU / mL | Standard Deviation 31.41 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,821 (n=257, 109) | 43.03 IU / mL | Standard Deviation 22.86 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,821 (n=275, 124) | 31.41 IU / mL | Standard Deviation 29.3 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 729 (n=307, 132) | 43.74 IU / mL | Standard Deviation 23.44 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,989 (n=114, 49) | 42.61 IU / mL | Standard Deviation 24 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,457 (n=295, 132) | 32.13 IU / mL | Standard Deviation 30.14 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,989 (n=128, 61) | 33.22 IU / mL | Standard Deviation 34.65 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 729 (n=348, 153) | 32.12 IU / mL | Standard Deviation 30.99 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 2,185 (n=76, 29) | 45.04 IU / mL | Standard Deviation 23.46 |
| ABA + MTX DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 365 (n=343, 141) | 43.56 IU / mL | Standard Deviation 22.98 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 2,185 (n=83, 38) | 22.08 IU / mL | Standard Deviation 15.69 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,457 (n=270, 111) | 42.87 IU / mL | Standard Deviation 24.27 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,457 (n=295, 132) | 23.20 IU / mL | Standard Deviation 19.22 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 2,185 (n=76, 29) | 39.17 IU / mL | Standard Deviation 21.3 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 365 (n=343, 141) | 43.61 IU / mL | Standard Deviation 25.25 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 365 (n=373, 160) | 24.72 IU / mL | Standard Deviation 20.74 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 729 (n=307, 132) | 41.37 IU / mL | Standard Deviation 24.15 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 729 (n=348, 153) | 23.46 IU / mL | Standard Deviation 19.65 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,093 (n=283, 123) | 42.41 IU / mL | Standard Deviation 25.25 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,093 (n=306, 131) | 24.09 IU / mL | Standard Deviation 19.85 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,821 (n=257, 109) | 41.83 IU / mL | Standard Deviation 24.01 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,821 (n=275, 124) | 22.14 IU / mL | Standard Deviation 18.34 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | ESR Day 1,989 (n=114, 49) | 38.78 IU / mL | Standard Deviation 19.64 |
| MTX + Placebo DB | Mean BL ESR and CRP Levels in the OL Period | CRP Day 1,989 (n=128, 61) | 20.39 IU / mL | Standard Deviation 14.43 |
Secondary
Mean BL Fatigue in the OL Period
Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=275, 124) | 63.18 Units on a Scale | Standard Deviation 23.78 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 449 Cohort (n=358, 156) | 63.59 Units on a Scale | Standard Deviation 23.51 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 813 Cohort (n=318, 141) | 63.77 Units on a Scale | Standard Deviation 22.77 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=271, 123) | 64.05 Units on a Scale | Standard Deviation 22.73 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 63.38 Units on a Scale | Standard Deviation 23.37 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=141, 59) | 65.64 Units on a Scale | Standard Deviation 21.44 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=283, 129) | 63.66 Units on a Scale | Standard Deviation 23.51 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=263, 125) | 62.48 Units on a Scale | Standard Deviation 23.84 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=115, 53) | 64.36 Units on a Scale | Standard Deviation 23.88 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=81, 37) | 64.77 Units on a Scale | Standard Deviation 22.45 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 63.52 Units on a Scale | Standard Deviation 23.23 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 533 Cohort (n=353, 157) | 63.25 Units on a Scale | Standard Deviation 23.57 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 617 Cohort (n=339, 150) | 63.19 Units on a Scale | Standard Deviation 23.48 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 729 Cohort (n=329, 143) | 63.53 Units on a Scale | Standard Deviation 23.15 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 897 Cohort (n=316, 139) | 63.61 Units on a Scale | Standard Deviation 23.11 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 63.58 Units on a Scale | Standard Deviation 22.99 |
| ABA + MTX DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=307, 138) | 63.33 Units on a Scale | Standard Deviation 23.18 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 65.37 Units on a Scale | Standard Deviation 22.96 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=81, 37) | 70.17 Units on a Scale | Standard Deviation 19.01 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 729 Cohort (n=329, 143) | 64.59 Units on a Scale | Standard Deviation 23.73 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=275, 124) | 66.34 Units on a Scale | Standard Deviation 22.48 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=307, 138) | 65.47 Units on a Scale | Standard Deviation 23.34 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 813 Cohort (n=318, 141) | 64.81 Units on a Scale | Standard Deviation 23.59 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=271, 123) | 65.18 Units on a Scale | Standard Deviation 23.11 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 449 Cohort (n=358, 156) | 65.28 Units on a Scale | Standard Deviation 23.24 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 65.56 Units on a Scale | Standard Deviation 23.19 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 65.51 Units on a Scale | Standard Deviation 23.43 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=141, 59) | 69.00 Units on a Scale | Standard Deviation 20.57 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 533 Cohort (n=353, 157) | 65.78 Units on a Scale | Standard Deviation 22.89 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=283, 129) | 65.50 Units on a Scale | Standard Deviation 23 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 897 Cohort (n=316, 139) | 65.36 Units on a Scale | Standard Deviation 23.29 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=263, 125) | 65.00 Units on a Scale | Standard Deviation 23.15 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 617 Cohort (n=339, 150) | 64.73 Units on a Scale | Standard Deviation 23.42 |
| MTX + Placebo DB | Mean BL Fatigue in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=115, 53) | 67.45 Units on a Scale | Standard Deviation 22.16 |
Secondary
Mean BL General Health Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 35.43 Units on a Scale | Standard Error 8.41 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 35.33 Units on a Scale | Standard Error 8.45 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 35.34 Units on a Scale | Standard Error 8.4 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 35.41 Units on a Scale | Standard Error 8.38 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 35.47 Units on a Scale | Standard Error 8.46 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 35.72 Units on a Scale | Standard Error 8.5 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 35.67 Units on a Scale | Standard Error 8.46 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 35.69 Units on a Scale | Standard Error 8.52 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 35.50 Units on a Scale | Standard Error 8.38 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 135) | 35.65 Units on a Scale | Standard Error 8.38 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 35.88 Units on a Scale | Standard Error 8.68 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 35.56 Units on a Scale | Standard Error 8.48 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 35.67 Units on a Scale | Standard Error 8.33 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 35.61 Units on a Scale | Standard Error 8.46 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=119, 55) | 34.87 Units on a Scale | Standard Error 8.65 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 34.29 Units on a Scale | Standard Error 9.03 |
| ABA + MTX DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 35.59 Units on a Scale | Standard Error 8.45 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 35.32 Units on a Scale | Standard Error 7.8 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 35.27 Units on a Scale | Standard Error 7.73 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 135) | 35.31 Units on a Scale | Standard Error 7.88 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 35.28 Units on a Scale | Standard Error 7.8 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=119, 55) | 34.94 Units on a Scale | Standard Error 8.67 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 35.17 Units on a Scale | Standard Error 7.73 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 33.78 Units on a Scale | Standard Error 7.96 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 35.43 Units on a Scale | Standard Error 7.85 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 35.16 Units on a Scale | Standard Error 7.61 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 35.19 Units on a Scale | Standard Error 7.62 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 35.21 Units on a Scale | Standard Error 7.72 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 35.22 Units on a Scale | Standard Error 7.78 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 35.23 Units on a Scale | Standard Error 7.91 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 35.38 Units on a Scale | Standard Error 7.79 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 33.71 Units on a Scale | Standard Error 8.26 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 35.56 Units on a Scale | Standard Error 7.83 |
| MTX + Placebo DB | Mean BL General Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 35.54 Units on a Scale | Standard Error 7.87 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 365
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Hygiene (n=370, 160) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Walking (n=372, 158) | 1.40 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=372, 160) | 1.47 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Reaching (n=370, 160) | 1.94 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Arising (n=372, 160) | 1.42 Units on a Scale | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Gripping (n=371, 160) | 1.80 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | HAQ DI (n=369, 160) | 1.68 Units on a Scale | Standard Deviation 0.63 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Activities (n=369, 160) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Eating (n=372, 160) | 1.63 Units on a Scale | Standard Deviation 0.97 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Activities (n=369, 160) | 1.86 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Hygiene (n=370, 160) | 1.91 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | HAQ DI (n=369, 160) | 1.70 Units on a Scale | Standard Deviation 0.58 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Arising (n=372, 160) | 1.46 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Eating (n=372, 160) | 1.68 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Walking (n=372, 158) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Reaching (n=370, 160) | 1.97 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Gripping (n=371, 160) | 1.90 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=372, 160) | 1.49 Units on a Scale | Standard Deviation 0.73 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 449
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Walking (n=367, 155) | 1.40 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Activities (n=367, 157) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Hygiene (n=367, 157) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | HAQ DI (n=366, 157) | 1.69 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Reaching (n= 367, 157) | 1.94 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Arising (n=367, 157) | 1.42 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Gripping (n=368, 157) | 1.81 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=367, 157) | 1.48 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Eating (n=367, 157) | 1.64 Units on a Scale | Standard Deviation 0.97 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Activities (n=367, 157) | 1.87 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Arising (n=367, 157) | 1.46 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | HAQ DI (n=366, 157) | 1.71 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Eating (n=367, 157) | 1.67 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Walking (n=367, 155) | 1.37 Units on a Scale | Standard Deviation 0.76 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Hygiene (n=367, 157) | 1.92 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Reaching (n= 367, 157) | 1.97 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Gripping (n=368, 157) | 1.90 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=367, 157) | 1.49 Units on a Scale | Standard Deviation 0.73 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 533
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Reaching (n=354, 157) | 1.95 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | HAQ DI (n=354, 157) | 1.69 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=355, 156) | 1.47 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Arising (n=355, 157) | 1.42 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Eating (n=355, 156) | 1.64 Units on a Scale | Standard Deviation 0.98 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Walking (n=351, 156) | 1.40 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Hygiene (n=354, 157) | 1.94 Units on a Scale | Standard Deviation 0.91 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Gripping (n=354, 157) | 1.81 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Activities (n=354, 157) | 1.88 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Activities (n=354, 157) | 1.87 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Walking (n=351, 156) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | HAQ DI (n=354, 157) | 1.71 Units on a Scale | Standard Deviation 0.58 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Gripping (n=354, 157) | 1.91 Units on a Scale | Standard Deviation 0.66 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=355, 156) | 1.49 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Hygiene (n=354, 157) | 1.92 Units on a Scale | Standard Deviation 0.88 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Arising (n=355, 157) | 1.45 Units on a Scale | Standard Deviation 0.078 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Reaching (n=354, 157) | 1.97 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period | Eating (n=355, 156) | 1.67 Units on a Scale | Standard Deviation 0.84 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,093
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=310, 138) | 1.47 Units on a Scale | Standard Error 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Hygiene (n=310, 137) | 1.94 Units on a Scale | Standard Error 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Eating (n=309, 138) | 1.62 Units on a Scale | Standard Error 0.98 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Reaching (n=310, 137) | 1.96 Units on a Scale | Standard Error 0.87 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Arising (n=309, 138) | 1.41 Units on a Scale | Standard Error 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Gripping (n=310, 137) | 1.79 Units on a Scale | Standard Error 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Walking (n=308, 137) | 1.41 Units on a Scale | Standard Error 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Activities (n=310, 137) | 1.87 Units on a Scale | Standard Error 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | HAQ DI (n=308, 137) | 1.69 Units on a Scale | Standard Error 0.64 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Activities (n=310, 137) | 1.85 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | HAQ DI (n=308, 137) | 1.72 Units on a Scale | Standard Error 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=310, 138) | 1.51 Units on a Scale | Standard Error 0.75 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Arising (n=309, 138) | 1.45 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Eating (n=309, 138) | 1.69 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Walking (n=308, 137) | 1.36 Units on a Scale | Standard Error 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Hygiene (n=310, 137) | 1.92 Units on a Scale | Standard Error 0.9 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Reaching (n=310, 137) | 1.99 Units on a Scale | Standard Error 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period | Gripping (n=310, 137) | 1.92 Units on a Scale | Standard Error 0.68 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,177
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=274, 125) | 1.47 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Hygiene (n=275, 124) | 1.94 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Eating (n=274, 125) | 1.68 Units on a Scale | Standard Deviation 0.97 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Reaching (n=275, 125) | 1.96 Units on a Scale | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Arising (n=274, 125) | 1.39 Units on a Scale | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Gripping (n=275, 125) | 1.83 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Walking (n=272, 122) | 1.37 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Activities (n=275, 125) | 1.87 Units on a Scale | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | HAQ DI (n=274, 125) | 1.69 Units on a Scale | Standard Deviation 0.63 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Activities (n=275, 125) | 1.85 Units on a Scale | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | HAQ DI (n=274, 125) | 1.71 Units on a Scale | Standard Deviation 0.61 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=274, 125) | 1.53 Units on a Scale | Standard Deviation 0.77 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Arising (n=274, 125) | 1.45 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Eating (n=274, 125) | 1.70 Units on a Scale | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Walking (n=272, 122) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Hygiene (n=275, 124) | 1.90 Units on a Scale | Standard Deviation 0.91 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Reaching (n=275, 125) | 1.99 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period | Gripping (n=275, 125) | 1.91 Units on a Scale | Standard Deviation 0.68 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,261
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=292, 135) | 1.47 Units on a Scale | Standard Error 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Hygiene (n=292, 134) | 1.96 Units on a Scale | Standard Error 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Eating (n=292, 135) | 1.64 Units on a Scale | Standard Error 1 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Reaching (n=292, 134) | 1.97 Units on a Scale | Standard Error 0.87 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Arising (n=292, 135) | 1.42 Units on a Scale | Standard Error 0.85 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Gripping (n=292, 134) | 1.79 Units on a Scale | Standard Error 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Walking (n=290, 134) | 1.40 Units on a Scale | Standard Error 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Activities (n=292, 133) | 1.87 Units on a Scale | Standard Error 0.81 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | HAQ DI (n=292, 134) | 1.69 Units on a Scale | Standard Error 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Activities (n=292, 133) | 1.83 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | HAQ DI (n=292, 134) | 1.70 Units on a Scale | Standard Error 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=292, 135) | 1.51 Units on a Scale | Standard Error 0.75 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Arising (n=292, 135) | 1.44 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Eating (n=292, 135) | 1.69 Units on a Scale | Standard Error 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Walking (n=290, 134) | 1.36 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Hygiene (n=292, 134) | 1.92 Units on a Scale | Standard Error 0.9 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Reaching (n=292, 134) | 1.97 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period | Gripping (n=292, 134) | 1.91 Units on a Scale | Standard Error 0.68 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,345
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | HAQ DI (n=152, 62) | 1.65 Units on a Scale | Standard Deviation 0.63 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Walking (n=151, 62) | 1.32 Units on a Scale | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Hygiene (n=152, 62) | 1.82 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Arising (n=152, 62) | 1.34 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Reaching (n=152, 62) | 1.98 Units on a Scale | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=152, 62) | 1.45 Units on a Scale | Standard Deviation 0.73 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Gripping (n=152, 62) | 1.77 Units on a Scale | Standard Deviation 0.74 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Eating (n=152, 62) | 1.63 Units on a Scale | Standard Deviation 0.97 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Activities (n=152, 62) | 1.88 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Eating (n=152, 62) | 1.69 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Activities (n=152, 62) | 1.79 Units on a Scale | Standard Deviation 0.77 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | HAQ DI (n=152, 62) | 1.73 Units on a Scale | Standard Deviation 0.58 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=152, 62) | 1.50 Units on a Scale | Standard Deviation 0.7 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Arising (n=152, 62) | 1.44 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Walking (n=151, 62) | 1.35 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Hygiene (n=152, 62) | 2.05 Units on a Scale | Standard Deviation 0.86 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Reaching (n=152, 62) | 2.06 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period | Gripping (n=152, 62) | 1.94 Units on a Scale | Standard Deviation 0.6 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,457
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=289, 129) | 1.48 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Hygiene (n=289, 129) | 1.95 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Eating (n=289, 129) | 1.64 Units on a Scale | Standard Deviation 1 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Reaching (n=289, 129) | 1.97 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Arising (n=289, 129) | 1.43 Units on a Scale | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Gripping (n=289, 129) | 1.80 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Walking (n=287, 126) | 1.42 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Activities (n=289, 129) | 1.88 Units on a Scale | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | HAQ DI (n=289, 129) | 1.70 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Activities (n=289, 129) | 1.84 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | HAQ DI (n=289, 129) | 1.71 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=289, 129) | 1.51 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Arising (n=289, 129) | 1.44 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Eating (n=289, 129) | 1.70 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Walking (n=287, 126) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Hygiene (n=289, 129) | 1.91 Units on a Scale | Standard Deviation 0.91 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Reaching (n=289, 129) | 1.99 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period | Gripping (n=289, 129) | 1.91 Units on a Scale | Standard Deviation 0.69 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,625
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Walking (n=279, 125) | 1.43 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Arising (n=280, 126) | 1.42 Units on a Scale | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Hygiene (n=280, 126) | 1.94 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Reaching (n=280, 126) | 1.96 Units on a Scale | Standard Deviation 0.85 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=280, 126) | 1.46 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Gripping (n=280, 126) | 1.80 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Eating (n=280, 126) | 1.63 Units on a Scale | Standard Deviation 0.99 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Activities (n=280, 126) | 1.88 Units on a Scale | Standard Deviation 0.8 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | HAQ DI (n=280, 126) | 1.69 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Activities (n=280, 126) | 1.87 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | HAQ DI (n=280, 126) | 1.72 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=280, 126) | 1.52 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Arising (n=280, 126) | 1.45 Units on a Scale | Standard Deviation 0.75 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Eating (n=280, 126) | 1.69 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Walking (n=279, 125) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Reaching (n=280, 126) | 2.00 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Gripping (n=280, 126) | 1.93 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period | Hygiene (n=280, 126) | 1.93 Units on a Scale | Standard Deviation 0.89 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=273, 125) | 1.47 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Hygiene (n=273, 125) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Eating (n=273, 124) | 1.63 Units on a Scale | Standard Deviation 1 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Reaching (n=273, 125) | 1.97 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Arising (n=273, 125) | 1.41 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Gripping (n=273, 125) | 1.79 Units on a Scale | Standard Deviation 0.78 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Walking (n=271, 122) | 1.43 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Activities (n=273, 125) | 1.88 Units on a Scale | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | HAQ DI (n=273, 125) | 1.69 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Activities (n=273, 125) | 1.82 Units on a Scale | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | HAQ DI (n=273, 125) | 1.69 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=273, 125) | 1.49 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Arising (n=273, 125) | 1.42 Units on a Scale | Standard Deviation 0.76 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Eating (n=273, 124) | 1.67 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Walking (n=271, 122) | 1.34 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Hygiene (n=273, 125) | 1.88 Units on a Scale | Standard Deviation 0.91 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Reaching (n=273, 125) | 1.97 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period | Gripping (n=273, 125) | 1.90 Units on a Scale | Standard Deviation 0.7 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,989
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Walking (n=117, 54) | 1.45 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Arising (n=119, 55) | 1.36 Units on a Scale | Standard Deviation 0.78 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Hygiene (n=119, 55) | 1.87 Units on a Scale | Standard Deviation 0.94 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Reaching (n=119, 55) | 2.08 Units on a Scale | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=119, 55) | 1.51 Units on a Scale | Standard Deviation 0.72 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Gripping (n=119, 55) | 1.85 Units on a Scale | Standard Deviation 0.74 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Eating (n=119, 55) | 1.66 Units on a Scale | Standard Deviation 0.99 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Activities (n=119, 55) | 1.97 Units on a Scale | Standard Deviation 0.81 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | HAQ DI (n=119, 55) | 1.72 Units on a Scale | Standard Deviation 0.61 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Activities (n=119, 55) | 1.84 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | HAQ DI (n=119, 55) | 1.67 Units on a Scale | Standard Deviation 0.62 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=119, 55) | 1.49 Units on a Scale | Standard Deviation 0.69 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Arising (n=119, 55) | 1.38 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Eating (n=119, 55) | 1.62 Units on a Scale | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Walking (n=117, 54) | 1.30 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Reaching (n=119, 55) | 1.98 Units on a Scale | Standard Deviation 0.76 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Gripping (n=119, 55) | 1.87 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period | Hygiene (n=119, 55) | 1.89 Units on a Scale | Standard Deviation 0.92 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Activities (n=85, 38) | 2.04 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | HAQ DI (n=85, 38) | 1.73 Units on a Scale | Standard Deviation 0.55 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=85, 37) | 1.54 Units on a Scale | Standard Deviation 0.7 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Arising (n=85, 38) | 1.36 Units on a Scale | Standard Deviation 0.72 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Eating (n=85, 38) | 1.64 Units on a Scale | Standard Deviation 0.96 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Walking (n=84, 38) | 1.39 Units on a Scale | Standard Deviation 0.73 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Hygiene (n=85, 38) | 1.86 Units on a Scale | Standard Deviation 0.91 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Reaching (n=85, 38) | 2.11 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Gripping (n=85, 38) | 1.86 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Reaching (n=85, 38) | 2.03 Units on a Scale | Standard Deviation 0.68 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Walking (n=84, 38) | 1.37 Units on a Scale | Standard Deviation 0.71 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | HAQ DI (n=85, 38) | 1.69 Units on a Scale | Standard Deviation 0.49 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Activities (n=85, 38) | 1.84 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=85, 37) | 1.54 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Hygiene (n=85, 38) | 1.97 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Arising (n=85, 38) | 1.37 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Gripping (n=85, 38) | 1.84 Units on a Scale | Standard Deviation 0.55 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period | Eating (n=85, 38) | 1.58 Units on a Scale | Standard Deviation 0.79 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 617
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Hygiene (n=348, 155) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Walking (n=348, 154) | 1.40 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=348, 155) | 1.47 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Reaching (n=348, 155) | 1.96 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | HAQ DI (n=348, 154) | 1.69 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Gripping (n=348, 154) | 1.82 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Arising (n=348, 155) | 1.42 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Activities (n=348, 155) | 1.88 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Eating (n=348, 155) | 1.64 Units on a Scale | Standard Deviation 0.97 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Activities (n=348, 155) | 1.87 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Hygiene (n=348, 155) | 1.92 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | HAQ DI (n=348, 154) | 1.71 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=348, 155) | 1.50 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Eating (n=348, 155) | 1.68 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Walking (n=348, 154) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Reaching (n=348, 155) | 1.97 Units on a Scale | Standard Deviation 0.81 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Gripping (n=348, 154) | 1.91 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period | Arising (n=348, 155) | 1.46 Units on a Scale | Standard Deviation 0.79 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 729
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Walking (n=338, 147) | 1.41 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Arising (n=338, 148) | 1.41 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Hygiene (n=338, 148) | 1.93 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=337, 148) | 1.48 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Reaching (n=336, 148) | 1.95 Units on a Scale | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Gripping (n=338, 148) | 1.81 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Eating (n= 337, 148) | 1.63 Units on a Scale | Standard Deviation 0.98 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Activities (n=338, 148) | 1.86 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | HAQ DI (n=337, 148) | 1.69 Units on a Scale | Standard Deviation 0.64 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Activities (n=338, 148) | 1.89 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | HAQ DI (n=337, 148) | 1.72 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=337, 148) | 1.51 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Arising (n=338, 148) | 1.45 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Eating (n= 337, 148) | 1.72 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Walking (n=338, 147) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Hygiene (n=338, 148) | 1.93 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Gripping (n=338, 148) | 1.92 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period | Reaching (n=336, 148) | 1.97 Units on a Scale | Standard Deviation 0.81 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 813
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Gripping (n=325, 146) | 1.81 Units on a Scale | Standard Deviation 0.77 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Walking (n=324, 146) | 1.42 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=325, 147) | 1.48 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Hygiene (n=325, 146) | 1.95 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | HAQ DI (n=325, 146) | 1.70 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Reaching (n=324, 146) | 1.97 Units on a Scale | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Eating (n=325, 147) | 1.65 Units on a Scale | Standard Deviation 0.98 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Activities (n=324, 146) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Arising (n=325, 147) | 1.42 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Activities (n=324, 146) | 1.87 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Arising (n=325, 147) | 1.46 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Reaching (n=324, 146) | 1.97 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | HAQ DI (n=325, 146) | 1.72 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=325, 147) | 1.51 Units on a Scale | Standard Deviation 0.74 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Eating (n=325, 147) | 1.70 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Walking (n=324, 146) | 1.38 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Hygiene (n=325, 146) | 1.94 Units on a Scale | Standard Deviation 0.9 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period | Gripping (n=325, 146) | 1.92 Units on a Scale | Standard Deviation 0.66 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 897
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | HAQ DI (n=318, 140) | 1.69 Units on a Scale | Standard Deviation 0.64 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=319, 140) | 1.47 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Arising (n=319, 140) | 1.43 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Eating (n=319, 140) | 1.63 Units on a Scale | Standard Deviation 0.99 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Walking (n=319, 138) | 1.41 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Hygiene (n=319, 140) | 1.95 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Reaching (n=319, 140) | 1.96 Units on a Scale | Standard Deviation 0.87 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Gripping (n=319, 140) | 1.80 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Activities (n=319, 140) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Gripping (n=319, 140) | 1.92 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Hygiene (n=319, 140) | 1.94 Units on a Scale | Standard Deviation 0.9 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=319, 140) | 1.52 Units on a Scale | Standard Deviation 0.75 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | HAQ DI (n=318, 140) | 1.72 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Arising (n=319, 140) | 1.46 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Reaching (n=319, 140) | 2.01 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Eating (n=319, 140) | 1.71 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Activities (n=319, 140) | 1.87 Units on a Scale | Standard Deviation 0.85 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period | Walking (n=319, 138) | 1.38 Units on a Scale | Standard Deviation 0.79 |
Secondary
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 981
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=312, 137) | 1.47 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Hygiene (n=312, 137) | 1.94 Units on a Scale | Standard Deviation 0.89 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Eating (n=312, 137) | 1.63 Units on a Scale | Standard Deviation 0.99 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Reaching (n=312, 137) | 1.97 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Arising (n=312, 137) | 1.42 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Gripping (n=312, 137) | 1.80 Units on a Scale | Standard Deviation 0.78 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Walking (n=308, 136) | 1.41 Units on a Scale | Standard Deviation 0.84 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Activities (n=312, 137) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | HAQ DI (n=312, 137) | 1.69 Units on a Scale | Standard Deviation 0.65 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Activities (n=312, 137) | 1.85 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | HAQ DI (n=312, 137) | 1.72 Units on a Scale | Standard Deviation 0.6 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Dressing and Grooming (n=312, 137) | 1.52 Units on a Scale | Standard Deviation 0.75 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Arising (n=312, 137) | 1.45 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Eating (n=312, 137) | 1.70 Units on a Scale | Standard Deviation 0.83 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Walking (n=308, 136) | 1.37 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Hygiene (n=312, 137) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Reaching (n=312, 137) | 1.99 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period | Gripping (n=312, 137) | 1.92 Units on a Scale | Standard Deviation 0.68 |
Secondary
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | HAQ DI Day 169 (n=373, 159) | 1.68 Units on a Scale | Standard Deviation 0.63 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | HAQ DI Day 365 (n=369, 160) | 1.68 Units on a Scale | Standard Deviation 0.63 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Dressing and Grooming Day 169 (n=374, 159) | 1.48 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Dressing and Grooming Day 365 (n=372, 160) | 1.47 Units on a Scale | Standard Deviation 0.75 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Arising Day 169 (n=373, 159) | 1.42 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Arising Day 365 (n=372, 160) | 1.42 Units on a Scale | Standard Deviation 0.82 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Eating Day 169 (n=374, 159) | 1.63 Units on a Scale | Standard Deviation 0.97 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Eating Day 365 (n=372, 160) | 1.63 Units on a Scale | Standard Deviation 0.97 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Walking Day 169 (n=373, 158) | 1.40 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Walking Day 365 (n=372, 158) | 1.40 Units on a Scale | Standard Deviation 0.83 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Hygiene Day 169 (n=373, 159) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Hygiene Day 365 (n=370, 160) | 1.93 Units on a Scale | Standard Deviation 0.9 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Reaching Day 169 (n=373, 159) | 1.94 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Reaching Day 365 (n=370, 160) | 1.94 Units on a Scale | Standard Deviation 0.86 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Gripping Day 169 (n=374, 159) | 1.80 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Gripping Day 365 (n=371, 160) | 1.80 Units on a Scale | Standard Deviation 0.76 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Activities Day 169 (n=373, 159) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| ABA + MTX DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Activities Day 365 (n=369, 160) | 1.87 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Reaching Day 365 (n=370, 160) | 1.97 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | HAQ DI Day 169 (n=373, 159) | 1.70 Units on a Scale | Standard Deviation 0.59 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Walking Day 365 (n=372, 158) | 1.37 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | HAQ DI Day 365 (n=369, 160) | 1.70 Units on a Scale | Standard Deviation 0.58 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Activities Day 365 (n=369, 160) | 1.86 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Dressing and Grooming Day 169 (n=374, 159) | 1.48 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Hygiene Day 169 (n=373, 159) | 1.91 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Dressing and Grooming Day 365 (n=372, 160) | 1.49 Units on a Scale | Standard Deviation 0.73 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Gripping Day 169 (n=374, 159) | 1.90 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Arising Day 169 (n=373, 159) | 1.45 Units on a Scale | Standard Deviation 0.79 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Hygiene Day 365 (n=370, 160) | 1.91 Units on a Scale | Standard Deviation 0.89 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Arising Day 365 (n=372, 160) | 1.46 Units on a Scale | Standard Deviation 0.78 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Activities Day 169 (n=373, 159) | 1.86 Units on a Scale | Standard Deviation 0.82 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Eating Day 169 (n=374, 159) | 1.67 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Reaching Day 169 (n=373, 159) | 1.97 Units on a Scale | Standard Deviation 0.8 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Eating Day 365 (n=372, 160) | 1.68 Units on a Scale | Standard Deviation 0.84 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Gripping Day 365 (n=371, 160) | 1.90 Units on a Scale | Standard Deviation 0.67 |
| MTX + Placebo DB | Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 | Walking Day 169 (n=373, 158) | 1.36 Units on a Scale | Standard Deviation 0.78 |
Secondary
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) IL-6 for Day 169 Cohort (n=357, 175) | 36.35 pg / mL | Standard Deviation 43.53 |
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) SIL-2R for Day 365 Cohort (n=235, 106) | 1674 pg / mL | Standard Deviation 835.1 |
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) SIL-2R for Day 169 Cohort (n=370, 171) | 1776 pg / mL | Standard Deviation 946.5 |
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) TNF-Alpha for D169 Cohort (n=354,172) | 5.94 pg / mL | Standard Deviation 7.9 |
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) IL-6 for Day 365 Cohort (n=247, 121) | 35.27 pg / mL | Standard Deviation 49.06 |
| ABA + MTX DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) TNF-Alpha for D365 Cohort (n=246, 119) | 5.55 pg / mL | Standard Deviation 7.84 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) IL-6 for Day 365 Cohort (n=247, 121) | 37.89 pg / mL | Standard Deviation 49.61 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) IL-6 for Day 169 Cohort (n=357, 175) | 39.90 pg / mL | Standard Deviation 54.43 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) TNF-Alpha for D169 Cohort (n=354,172) | 7.86 pg / mL | Standard Deviation 29.41 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) SIL-2R for Day 365 Cohort (n=235, 106) | 1601 pg / mL | Standard Deviation 1076 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) TNF-Alpha for D365 Cohort (n=246, 119) | 5.46 pg / mL | Standard Deviation 8.63 |
| MTX + Placebo DB | Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | BL (Day 0) SIL-2R for Day 169 Cohort (n=370, 171) | 1603 pg / mL | Standard Deviation 933.1 |
Secondary
Mean BL Limitations on Activities of Daily Living in the OL Period
Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 365 Cohort (n=360, 153) | 13.80 Days | Standard Deviation 10.98 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 449 Cohort (n=348, 150) | 13.82 Days | Standard Deviation 10.92 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 533 Cohort (n=338, 148) | 13.91 Days | Standard Deviation 11.06 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=133, 57) | 15.71 Days | Standard Deviation 11.2 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 617 Cohort (n=332, 140) | 14.01 Days | Standard Deviation 11.1 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 729 Cohort (n=316, 138) | 13.96 Days | Standard Deviation 11.11 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 813 Cohort (n=306, 133) | 14.31 Days | Standard Deviation 11.14 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 897 Cohort (n=302, 131) | 14.08 Days | Standard Deviation 11.14 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 981 Cohort (n=300, 129) | 14.13 Days | Standard Deviation 11.19 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=292, 130) | 14.34 Days | Standard Deviation 11.15 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=259, 118) | 14.53 Days | Standard Deviation 11.17 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=231, 105) | 15.00 Days | Standard Deviation 11.01 |
| ABA + MTX DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=196, 84) | 15.36 Days | Standard Deviation 11.16 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=259, 118) | 13.80 Days | Standard Deviation 13.28 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 813 Cohort (n=306, 133) | 13.38 Days | Standard Deviation 12.88 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 449 Cohort (n=348, 150) | 13.19 Days | Standard Deviation 12.65 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=292, 130) | 13.79 Days | Standard Deviation 12.95 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 533 Cohort (n=338, 148) | 13.55 Days | Standard Deviation 12.7 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=231, 105) | 13.81 Days | Standard Deviation 13.16 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 897 Cohort (n=302, 131) | 13.81 Days | Standard Deviation 12.91 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=133, 57) | 15.05 Days | Standard Deviation 11.29 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 365 Cohort (n=360, 153) | 13.21 Days | Standard Deviation 12.64 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=196, 84) | 14.87 Days | Standard Deviation 13.96 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 617 Cohort (n=332, 140) | 13.23 Days | Standard Deviation 12.72 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 981 Cohort (n=300, 129) | 13.70 Days | Standard Deviation 13.03 |
| MTX + Placebo DB | Mean BL Limitations on Activities of Daily Living in the OL Period | BL (Day 0) for Day 729 Cohort (n=316, 138) | 13.52 Days | Standard Deviation 12.78 |
Secondary
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=362, 156) | 41.20 Units on a Scale | Standard Deviation 11.29 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 124) | 41.28 Units on a Scale | Standard Deviation 11.47 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 145) | 41.23 Units on a Scale | Standard Deviation 11.34 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 41.29 Units on a Scale | Standard Deviation 11.45 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 153) | 41.23 Units on a Scale | Standard Deviation 11.28 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 42.11 Units on a Scale | Standard Deviation 11.81 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 41.36 Units on a Scale | Standard Deviation 11.41 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=288, 128) | 41.35 Units on a Scale | Standard Deviation 11.45 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 41.28 Units on a Scale | Standard Deviation 11.2 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=278, 125) | 41.25 Units on a Scale | Standard Deviation 11.6 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 41.40 Units on a Scale | Standard Deviation 11.39 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 41.39 Units on a Scale | Standard Deviation 11.6 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 146) | 41.21 Units on a Scale | Standard Deviation 11.28 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 41.73 Units on a Scale | Standard Deviation 11.58 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=308, 137) | 41.40 Units on a Scale | Standard Deviation 11.25 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 42.00 Units on a Scale | Standard Deviation 11.97 |
| ABA + MTX DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=370, 157) | 41.40 Units on a Scale | Standard Deviation 11.35 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 37.55 Units on a Scale | Standard Deviation 9.95 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=370, 157) | 40.56 Units on a Scale | Standard Deviation 11.18 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=362, 156) | 40.47 Units on a Scale | Standard Deviation 11.11 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 40.53 Units on a Scale | Standard Deviation 11.25 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 153) | 40.67 Units on a Scale | Standard Deviation 11.26 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 146) | 40.24 Units on a Scale | Standard Deviation 11.11 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 145) | 40.19 Units on a Scale | Standard Deviation 11.2 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 40.28 Units on a Scale | Standard Deviation 11.33 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 40.32 Units on a Scale | Standard Deviation 11.45 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=308, 137) | 40.33 Units on a Scale | Standard Deviation 11.41 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 124) | 40.19 Units on a Scale | Standard Deviation 11.06 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 40.26 Units on a Scale | Standard Deviation 11.5 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 39.99 Units on a Scale | Standard Deviation 10.83 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=288, 128) | 40.06 Units on a Scale | Standard Deviation 11.35 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=278, 125) | 40.16 Units on a Scale | Standard Deviation 11.44 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 40.03 Units on a Scale | Standard Deviation 11.23 |
| MTX + Placebo DB | Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 39.61 Units on a Scale | Standard Deviation 9.98 |
Secondary
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 38.75 Units on a Scale | Standard Error 11.56 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 39.06 Units on a Scale | Standard Error 11.58 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 159) | 39.08 Units on a Scale | Standard Error 11.55 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 39.16 Units on a Scale | Standard Error 11.47 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 146) | 38.85 Units on a Scale | Standard Error 11.57 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 38.81 Units on a Scale | Standard Error 11.56 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 125) | 38.88 Units on a Scale | Standard Error 11.54 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 39.91 Units on a Scale | Standard Error 11.46 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 38.76 Units on a Scale | Standard Error 11.46 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 38.88 Units on a Scale | Standard Error 11.66 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 38.89 Units on a Scale | Standard Error 11.44 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 39.06 Units on a Scale | Standard Error 11.72 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 38.83 Units on a Scale | Standard Error 11.62 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 38.95 Units on a Scale | Standard Error 10.99 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 38.96 Units on a Scale | Standard Error 11.66 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 39.32 Units on a Scale | Standard Error 12.04 |
| ABA + MTX DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 156) | 38.87 Units on a Scale | Standard Error 11.46 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 37.40 Units on a Scale | Standard Error 10.09 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 156) | 39.33 Units on a Scale | Standard Error 11.14 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 39.49 Units on a Scale | Standard Error 11.14 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 125) | 38.67 Units on a Scale | Standard Error 11.22 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 38.93 Units on a Scale | Standard Error 11.42 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 159) | 39.43 Units on a Scale | Standard Error 11.09 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 39.40 Units on a Scale | Standard Error 11.18 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 39.05 Units on a Scale | Standard Error 11.18 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 146) | 39.01 Units on a Scale | Standard Error 11.19 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 39.03 Units on a Scale | Standard Error 11.35 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 39.09 Units on a Scale | Standard Error 11.46 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 39.08 Units on a Scale | Standard Error 11.42 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 39.15 Units on a Scale | Standard Error 11.49 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 39.33 Units on a Scale | Standard Error 11.21 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 38.97 Units on a Scale | Standard Error 11.46 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 38.95 Units on a Scale | Standard Error 11.44 |
| MTX + Placebo DB | Mean BL Mental Health Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 39.90 Units on a Scale | Standard Error 10.63 |
Secondary
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 30.64 Units on a Scale | Standard Deviation 6.86 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=308, 137) | 30.51 Units on a Scale | Standard Deviation 6.67 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 153) | 30.70 Units on a Scale | Standard Deviation 6.81 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 124) | 30.58 Units on a Scale | Standard Deviation 6.78 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=362, 156) | 30.55 Units on a Scale | Standard Deviation 6.78 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 30.40 Units on a Scale | Standard Deviation 6.32 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 146) | 30.75 Units on a Scale | Standard Deviation 6.78 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=288, 128) | 30.51 Units on a Scale | Standard Deviation 6.76 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=370, 157) | 30.69 Units on a Scale | Standard Deviation 6.84 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=278, 125) | 30.70 Units on a Scale | Standard Deviation 6.78 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 145) | 30.58 Units on a Scale | Standard Deviation 6.66 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 30.54 Units on a Scale | Standard Deviation 6.81 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 155) | 30.64 Units on a Scale | Standard Deviation 6.79 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 29.80 Units on a Scale | Standard Deviation 6.72 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 30.52 Units on a Scale | Standard Deviation 6.69 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 28.80 Units on a Scale | Standard Deviation 5.77 |
| ABA + MTX DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 30.49 Units on a Scale | Standard Deviation 6.64 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 29.74 Units on a Scale | Standard Deviation 5.72 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 30.98 Units on a Scale | Standard Deviation 7.46 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 31.02 Units on a Scale | Standard Deviation 7.47 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=370, 157) | 30.94 Units on a Scale | Standard Deviation 7.32 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=362, 156) | 30.95 Units on a Scale | Standard Deviation 7.34 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 155) | 30.86 Units on a Scale | Standard Deviation 7.34 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 153) | 30.88 Units on a Scale | Standard Deviation 7.37 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 146) | 30.88 Units on a Scale | Standard Deviation 7.25 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 145) | 31.00 Units on a Scale | Standard Deviation 7.29 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 30.87 Units on a Scale | Standard Deviation 7.41 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=308, 137) | 30.93 Units on a Scale | Standard Deviation 7.45 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 124) | 30.87 Units on a Scale | Standard Deviation 7.19 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 29.37 Units on a Scale | Standard Deviation 7.07 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=288, 128) | 31.23 Units on a Scale | Standard Deviation 7.46 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=278, 125) | 30.90 Units on a Scale | Standard Deviation 7.3 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 31.27 Units on a Scale | Standard Deviation 7.42 |
| MTX + Placebo DB | Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 30.66 Units on a Scale | Standard Deviation 7.61 |
Secondary
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 28.70 Units on a Scale | Standard Error 8.97 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 28.79 Units on a Scale | Standard Error 9.12 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 28.62 Units on a Scale | Standard Error 9.06 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 28.63 Units on a Scale | Standard Error 9.13 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 28.71 Units on a Scale | Standard Error 9.13 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort(n=338, 148) | 28.68 Units on a Scale | Standard Error 9.2 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 28.41 Units on a Scale | Standard Error 8.97 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 28.36 Units on a Scale | Standard Error 8.99 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 28.43 Units on a Scale | Standard Error 9.01 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=310, 138) | 28.43 Units on a Scale | Standard Error 8.98 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 28.70 Units on a Scale | Standard Error 8.95 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 135) | 28.62 Units on a Scale | Standard Error 9.12 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 28.35 Units on a Scale | Standard Error 9.11 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 28.68 Units on a Scale | Standard Error 9.1 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 28.50 Units on a Scale | Standard Error 9.07 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 27.78 Units on a Scale | Standard Error 8.86 |
| ABA + MTX DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 26.94 Units on a Scale | Standard Error 7.79 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 26.25 Units on a Scale | Standard Error 7.45 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=310, 138) | 28.10 Units on a Scale | Standard Error 9.11 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 28.09 Units on a Scale | Standard Error 8.88 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 27.98 Units on a Scale | Standard Error 8.87 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 28.07 Units on a Scale | Standard Error 8.95 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 27.91 Units on a Scale | Standard Error 8.85 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 28.05 Units on a Scale | Standard Error 8.91 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 27.75 Units on a Scale | Standard Error 9.35 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 28.02 Units on a Scale | Standard Error 8.91 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 135) | 28.17 Units on a Scale | Standard Error 9.13 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort(n=338, 148) | 28.01 Units on a Scale | Standard Error 8.93 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 26.49 Units on a Scale | Standard Error 8.34 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 28.01 Units on a Scale | Standard Error 9.01 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 28.50 Units on a Scale | Standard Error 9.03 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 27.93 Units on a Scale | Standard Error 9.11 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 28.24 Units on a Scale | Standard Error 9.03 |
| MTX + Placebo DB | Mean BL Physical Function Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 28.10 Units on a Scale | Standard Error 9.15 |
Secondary
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 35.46 Units on a Scale | Standard Error 13.4 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 35.43 Units on a Scale | Standard Error 13.5 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 124) | 35.46 Units on a Scale | Standard Error 13.34 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 35.61 Units on a Scale | Standard Error 13.67 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 35.26 Units on a Scale | Standard Error 13.76 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 146) | 35.38 Units on a Scale | Standard Error 13.42 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n= 370, 158) | 35.78 Units on a Scale | Standard Error 13.63 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 35.42 Units on a Scale | Standard Error 13.36 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 35.61 Units on a Scale | Standard Error 13.57 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 36.00 Units on a Scale | Standard Error 13.78 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 35.66 Units on a Scale | Standard Error 13.55 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 137) | 35.40 Units on a Scale | Standard Error 13.36 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 133) | 35.61 Units on a Scale | Standard Error 13.44 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 128) | 35.36 Units on a Scale | Standard Error 13.44 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 35.49 Units on a Scale | Standard Error 13.49 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 125) | 35.33 Units on a Scale | Standard Error 13.39 |
| ABA + MTX DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=365, 157) | 35.71 Units on a Scale | Standard Error 13.61 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 54) | 30.76 Units on a Scale | Standard Error 11.58 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=365, 157) | 33.26 Units on a Scale | Standard Error 12.44 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 33.52 Units on a Scale | Standard Error 12.6 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 33.34 Units on a Scale | Standard Error 12.45 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 146) | 33.26 Units on a Scale | Standard Error 12.52 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 139) | 33.13 Units on a Scale | Standard Error 12.6 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 136) | 33.19 Units on a Scale | Standard Error 12.65 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 137) | 33.27 Units on a Scale | Standard Error 12.64 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 124) | 33.42 Units on a Scale | Standard Error 12.57 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=291, 133) | 33.00 Units on a Scale | Standard Error 12.51 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=146, 60) | 32.69 Units on a Scale | Standard Error 12.39 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 125) | 32.92 Units on a Scale | Standard Error 12.48 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 124) | 32.74 Units on a Scale | Standard Error 12.14 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 29.28 Units on a Scale | Standard Error 10.32 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n= 370, 158) | 33.40 Units on a Scale | Standard Error 12.53 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 33.39 Units on a Scale | Standard Error 12.61 |
| MTX + Placebo DB | Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 128) | 32.79 Units on a Scale | Standard Error 12.31 |
Secondary
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 32.12 Units on a Scale | Standard Deviation 7.86 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 31.83 Units on a Scale | Standard Deviation 7.56 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 31.90 Units on a Scale | Standard Deviation 7.13 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 31.88 Units on a Scale | Standard Deviation 7.64 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 31.82 Units on a Scale | Standard Deviation 7.57 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 31.93 Units on a Scale | Standard Deviation 7.65 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 31.87 Units on a Scale | Standard Deviation 7.71 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 31.91 Units on a Scale | Standard Deviation 7.56 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 31.79 Units on a Scale | Standard Deviation 7.72 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 32.04 Units on a Scale | Standard Deviation 7.81 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 31.83 Units on a Scale | Standard Deviation 7.52 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=372, 160) | 32.06 Units on a Scale | Standard Deviation 7.78 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 32.02 Units on a Scale | Standard Deviation 7.78 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 31.84 Units on a Scale | Standard Deviation 7.55 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 138) | 31.82 Units on a Scale | Standard Deviation 7.52 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 31.88 Units on a Scale | Standard Deviation 7.6 |
| ABA + MTX DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 30.98 Units on a Scale | Standard Deviation 6.88 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 31.88 Units on a Scale | Standard Deviation 7.22 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=367, 157) | 32.02 Units on a Scale | Standard Deviation 7.4 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 32.11 Units on a Scale | Standard Deviation 7.39 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 32.14 Units on a Scale | Standard Deviation 7.41 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 31.79 Units on a Scale | Standard Deviation 6.83 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 31.91 Units on a Scale | Standard Deviation 7.14 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 32.01 Units on a Scale | Standard Deviation 7.27 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 32.05 Units on a Scale | Standard Deviation 7.32 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=372, 160) | 32.08 Units on a Scale | Standard Deviation 7.34 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 61) | 31.66 Units on a Scale | Standard Deviation 6.53 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 32.08 Units on a Scale | Standard Deviation 7.34 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=279, 126) | 31.96 Units on a Scale | Standard Deviation 7.25 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 31.71 Units on a Scale | Standard Deviation 6.95 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 31.43 Units on a Scale | Standard Deviation 6.92 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=84, 38) | 30.56 Units on a Scale | Standard Deviation 5.05 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=309, 138) | 32.02 Units on a Scale | Standard Deviation 7.31 |
| MTX + Placebo DB | Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 32.09 Units on a Scale | Standard Deviation 7.38 |
Secondary
Mean BL Sleep Quality in the OL Period
Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 42.42 Units on a Scale | Standard Deviation 19.96 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 449 Cohort (n=358, 156) | 42.77 Units on a Scale | Standard Deviation 20.07 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 617 Cohort (n=339, 150) | 42.51 Units on a Scale | Standard Deviation 20.19 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 729 Cohort (n=329, 143) | 42.28 Units on a Scale | Standard Deviation 20.01 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 813 Cohort (n=318, 141) | 42.63 Units on a Scale | Standard Deviation 20.07 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 897 Cohort (n=316, 139) | 42.60 Units on a Scale | Standard Deviation 20.31 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 42.51 Units on a Scale | Standard Deviation 20.25 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=307, 138) | 42.69 Units on a Scale | Standard Deviation 20.36 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=270, 124) | 43.08 Units on a Scale | Standard Deviation 20.28 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=272, 122) | 42.70 Units on a Scale | Standard Deviation 20.46 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=263, 125) | 42.04 Units on a Scale | Standard Deviation 20.53 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=81, 37) | 42.70 Units on a Scale | Standard Deviation 22.06 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 533 Cohort (n=353, 157) | 42.62 Units on a Scale | Standard Deviation 20.11 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 42.87 Units on a Scale | Standard Deviation 20.4 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=141, 59) | 41.78 Units on a Scale | Standard Deviation 21.79 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=275, 124) | 42.93 Units on a Scale | Standard Deviation 20.82 |
| ABA + MTX DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=115, 53) | 43.15 Units on a Scale | Standard Deviation 22.33 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=270, 124) | 43.51 Units on a Scale | Standard Deviation 19.52 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=275, 124) | 44.14 Units on a Scale | Standard Deviation 19.74 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 449 Cohort (n=358, 156) | 43.22 Units on a Scale | Standard Deviation 19.64 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 533 Cohort (n=353, 157) | 43.24 Units on a Scale | Standard Deviation 19.39 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 43.53 Units on a Scale | Standard Deviation 19.59 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 617 Cohort (n=339, 150) | 43.24 Units on a Scale | Standard Deviation 19.9 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=272, 122) | 44.51 Units on a Scale | Standard Deviation 20 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 729 Cohort (n=329, 143) | 43.97 Units on a Scale | Standard Deviation 19.75 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=289, 133) | 43.76 Units on a Scale | Standard Deviation 19.83 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 813 Cohort (n=318, 141) | 43.58 Units on a Scale | Standard Deviation 19.7 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=263, 125) | 43.59 Units on a Scale | Standard Deviation 20 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 897 Cohort (n=316, 139) | 43.65 Units on a Scale | Standard Deviation 19.83 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=115, 53) | 47.62 Units on a Scale | Standard Deviation 20.33 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 43.58 Units on a Scale | Standard Deviation 19.78 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=141, 59) | 48.39 Units on a Scale | Standard Deviation 20.23 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=307, 138) | 43.78 Units on a Scale | Standard Deviation 19.84 |
| MTX + Placebo DB | Mean BL Sleep Quality in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=81, 37) | 51.43 Units on a Scale | Standard Deviation 19.75 |
Secondary
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 35.58 Units on a Scale | Standard Deviation 10.1 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 157) | 35.42 Units on a Scale | Standard Deviation 10.13 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 35.52 Units on a Scale | Standard Deviation 10.18 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 35.46 Units on a Scale | Standard Deviation 10.14 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 35.70 Units on a Scale | Standard Deviation 10.24 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 35.47 Units on a Scale | Standard Deviation 10.17 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 35.48 Units on a Scale | Standard Deviation 10.24 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 35.56 Units on a Scale | Standard Deviation 10.28 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 34.66 Units on a Scale | Standard Deviation 10.43 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 35.47 Units on a Scale | Standard Deviation 10.2 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 35.46 Units on a Scale | Standard Deviation 10.17 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 35.60 Units on a Scale | Standard Deviation 10.07 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 35.52 Units on a Scale | Standard Deviation 10.1 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 35.65 Units on a Scale | Standard Deviation 10.53 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 35.44 Units on a Scale | Standard Deviation 10.45 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 35.56 Units on a Scale | Standard Deviation 10.42 |
| ABA + MTX DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 34.50 Units on a Scale | Standard Deviation 10.41 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 33.75 Units on a Scale | Standard Deviation 8.92 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 34.73 Units on a Scale | Standard Deviation 9.9 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 157) | 34.91 Units on a Scale | Standard Deviation 9.75 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 31.85 Units on a Scale | Standard Deviation 8.21 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 157) | 34.94 Units on a Scale | Standard Deviation 9.8 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 160) | 34.98 Units on a Scale | Standard Deviation 9.72 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 156) | 35.01 Units on a Scale | Standard Deviation 9.8 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 34.68 Units on a Scale | Standard Deviation 9.86 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 148) | 34.51 Units on a Scale | Standard Deviation 9.61 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 34.65 Units on a Scale | Standard Deviation 9.82 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=324, 147) | 34.57 Units on a Scale | Standard Deviation 9.73 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=275, 125) | 34.51 Units on a Scale | Standard Deviation 9.6 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 33.24 Units on a Scale | Standard Deviation 9.09 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 34.82 Units on a Scale | Standard Deviation 9.93 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 34.67 Units on a Scale | Standard Deviation 9.9 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=289, 129) | 34.83 Units on a Scale | Standard Deviation 9.82 |
| MTX + Placebo DB | Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 34.86 Units on a Scale | Standard Deviation 9.52 |
Secondary
Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 169 (n=370, 171) | 1776.0 mg / mL | Standard Deviation 946.5 |
| ABA + MTX DB | Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 365 (n=235, 106) | 1674.0 mg / mL | Standard Deviation 835.1 |
| MTX + Placebo DB | Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 365 (n=235, 106) | 1601.0 mg / mL | Standard Deviation 1076 |
| MTX + Placebo DB | Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 169 (n=370, 171) | 1603.0 mg / mL | Standard Deviation 933.1 |
Secondary
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 40.77 Units on a Scale | Standard Deviation 9.02 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 40.84 Units on a Scale | Standard Deviation 9.18 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 40.85 Units on a Scale | Standard Deviation 9 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 40.85 Units on a Scale | Standard Deviation 9.07 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 42.19 Units on a Scale | Standard Deviation 8.85 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 40.74 Units on a Scale | Standard Deviation 9.11 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 41.16 Units on a Scale | Standard Deviation 9.08 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 125) | 40.69 Units on a Scale | Standard Deviation 9.23 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 159) | 40.93 Units on a Scale | Standard Deviation 9.14 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 156) | 40.77 Units on a Scale | Standard Deviation 9.11 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 40.68 Units on a Scale | Standard Deviation 8.99 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 146) | 40.60 Units on a Scale | Standard Deviation 9.06 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 41.30 Units on a Scale | Standard Deviation 9.39 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 40.79 Units on a Scale | Standard Deviation 9.11 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 40.78 Units on a Scale | Standard Deviation 9.15 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 40.79 Units on a Scale | Standard Deviation 9.21 |
| ABA + MTX DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 40.82 Units on a Scale | Standard Deviation 9.27 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,457 Cohort (n=290, 129) | 41.47 Units on a Scale | Standard Deviation 8.17 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 533 Cohort (n=355, 156) | 41.21 Units on a Scale | Standard Deviation 8.4 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 729 Cohort (n=338, 147) | 41.19 Units on a Scale | Standard Deviation 8.34 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 897 Cohort (n=320, 140) | 41.34 Units on a Scale | Standard Deviation 8.45 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,093 Cohort (n=312, 138) | 41.33 Units on a Scale | Standard Deviation 8.5 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,177 Cohort (n=273, 125) | 41.23 Units on a Scale | Standard Deviation 8.42 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,261 Cohort (n=292, 134) | 41.31 Units on a Scale | Standard Deviation 8.57 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,345 Cohort (n=147, 62) | 40.64 Units on a Scale | Standard Deviation 7.84 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 365 Cohort (n=373, 159) | 41.29 Units on a Scale | Standard Deviation 8.35 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,625 Cohort (n=280, 126) | 41.23 Units on a Scale | Standard Deviation 8.29 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,821 Cohort (n=273, 125) | 41.47 Units on a Scale | Standard Deviation 8.36 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 1,989 Cohort (n=118, 55) | 41.72 Units on a Scale | Standard Deviation 8.01 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 2,185 Cohort (n=85, 38) | 39.88 Units on a Scale | Standard Deviation 8.31 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 449 Cohort (n=368, 156) | 41.21 Units on a Scale | Standard Deviation 8.38 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 617 Cohort (n=348, 155) | 41.40 Units on a Scale | Standard Deviation 8.37 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 813 Cohort (n=323, 146) | 41.27 Units on a Scale | Standard Deviation 8.46 |
| MTX + Placebo DB | Mean BL Vitality Component of the SF-36 by Visit in the OL Period | BL (Day 0) for Day 981 Cohort (n=312, 137) | 41.43 Units on a Scale | Standard Deviation 8.45 |
Secondary
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 12.08 Units on a Scale | Standard Error 0.51 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 11.94 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 12.52 Units on a Scale | Standard Error 0.56 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 12.84 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 13.13 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 12.44 Units on a Scale | Standard Error 0.59 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 12.86 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,093 (n=309, 138) | 13.34 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 13.21 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 12.44 Units on a Scale | Standard Error 0.98 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 13.13 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 12.56 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 10.44 Units on a Scale | Standard Error 1.18 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 12.38 Units on a Scale | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,261 (n=291, 134) | 12.83 Units on a Scale | Standard Error 0.68 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 12.89 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 13.45 Units on a Scale | Standard Error 0.98 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 13.44 Units on a Scale | Standard Error 1.02 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 7.98 Units on a Scale | Standard Error 0.76 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 11.78 Units on a Scale | Standard Error 0.82 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,261 (n=291, 134) | 13.31 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 12.53 Units on a Scale | Standard Error 0.86 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 11.97 Units on a Scale | Standard Error 0.9 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 13.40 Units on a Scale | Standard Error 1.42 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 12.06 Units on a Scale | Standard Error 0.88 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 14.28 Units on a Scale | Standard Error 1.47 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 12.25 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 13.36 Units on a Scale | Standard Error 0.89 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 11.84 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 11.74 Units on a Scale | Standard Error 0.97 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 12.87 Units on a Scale | Standard Error 0.87 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 12.65 Units on a Scale | Standard Error 0.95 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,093 (n=309, 138) | 12.93 Units on a Scale | Standard Error 0.91 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 13.19 Units on a Scale | Standard Error 1.41 |
Secondary
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 7.07 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 6.94 Units on a Scale | Standard Error 0.46 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 6.82 Units on a Scale | Standard Error 0.47 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 7.22 Units on a Scale | Standard Error 0.45 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 7.31 Units on a Scale | Standard Error 0.46 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 6.89 Units on a Scale | Standard Error 0.49 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 6.86 Units on a Scale | Standard Error 0.52 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 7.31 Units on a Scale | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 7.24 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 7.48 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,261 (n=291, 135) | 7.18 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 6.19 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 7.27 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 7.50 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,989 (n=119, 55) | 6.55 Units on a Scale | Standard Error 0.81 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 5.93 Units on a Scale | Standard Error 1.02 |
| ABA + MTX DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 6.88 Units on a Scale | Standard Error 0.46 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 7.53 Units on a Scale | Standard Error 0.81 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 5.43 Units on a Scale | Standard Error 0.58 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 8.55 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 7.32 Units on a Scale | Standard Error 0.71 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 8.24 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 7.88 Units on a Scale | Standard Error 0.68 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,261 (n=291, 135) | 8.17 Units on a Scale | Standard Error 0.83 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 7.87 Units on a Scale | Standard Error 0.7 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,989 (n=119, 55) | 7.05 Units on a Scale | Standard Error 1.14 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 7.90 Units on a Scale | Standard Error 0.68 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 8.32 Units on a Scale | Standard Error 0.86 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 7.63 Units on a Scale | Standard Error 0.69 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 8.45 Units on a Scale | Standard Error 1.36 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 8.10 Units on a Scale | Standard Error 0.81 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 8.45 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 8.76 Units on a Scale | Standard Error 1.38 |
| MTX + Placebo DB | Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 8.36 Units on a Scale | Standard Error 0.82 |
Secondary
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 533 (n=355, 156) | 7.30 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 981 (n=312, 136) | 6.82 Units on a Scale | Standard Error 0.69 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 365 (n=370, 157) | 7.29 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,093 (n=308, 137) | 7.79 Units on a Scale | Standard Error 0.69 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 617 (n=348, 153) | 7.15 Units on a Scale | Standard Error 0.64 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,177 (n=273, 124) | 6.93 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,457 (n=288, 128) | 6.82 Units on a Scale | Standard Error 0.74 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,261 (n=289, 133) | 7.33 Units on a Scale | Standard Error 0.74 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 729 (n=338, 146) | 7.31 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,625 (n=278, 125) | 6.60 Units on a Scale | Standard Error 0.74 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 449 (n=362, 156) | 6.84 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 6.75 Units on a Scale | Standard Error 0.75 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 813 (n=323, 145) | 6.98 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 5.53 Units on a Scale | Standard Error 1.14 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 6.37 Units on a Scale | Standard Error 1 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 5.28 Units on a Scale | Standard Error 1.28 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 897 (n=320, 139) | 7.26 Units on a Scale | Standard Error 0.69 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 9.91 Units on a Scale | Standard Error 1.72 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,457 (n=288, 128) | 7.19 Units on a Scale | Standard Error 1.12 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 365 (n=370, 157) | 6.41 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 449 (n=362, 156) | 7.73 Units on a Scale | Standard Error 0.97 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 533 (n=355, 156) | 7.20 Units on a Scale | Standard Error 0.96 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 617 (n=348, 153) | 6.88 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 729 (n=338, 146) | 8.07 Units on a Scale | Standard Error 1.01 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 813 (n=323, 145) | 7.15 Units on a Scale | Standard Error 1.01 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 897 (n=320, 139) | 8.54 Units on a Scale | Standard Error 1.02 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 981 (n=312, 136) | 7.76 Units on a Scale | Standard Error 1.02 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,093 (n=308, 137) | 6.09 Units on a Scale | Standard Error 1.04 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,177 (n=273, 124) | 7.65 Units on a Scale | Standard Error 1.09 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 7.42 Units on a Scale | Standard Error 1.43 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,625 (n=278, 125) | 6.99 Units on a Scale | Standard Error 1.15 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 9.08 Units on a Scale | Standard Error 1.1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 8.74 Units on a Scale | Standard Error 1.6 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period | Day 1,261 (n=289, 133) | 7.04 Units on a Scale | Standard Error 1.05 |
Secondary
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 7.13 Units on a Scale | Standard Error 0.65 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 7.72 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 7.49 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 6.80 Units on a Scale | Standard Error 0.93 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 813 (n=323, 146) | 7.26 Units on a Scale | Standard Error 0.66 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 7.85 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 6.96 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,177 (n=273, 125) | 7.67 Units on a Scale | Standard Error 0.68 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 7.60 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 8.18 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 5.92 Units on a Scale | Standard Error 1.22 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 7.65 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 7.75 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 365 (n=373, 159) | 7.02 Units on a Scale | Standard Error 0.59 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 7.39 Units on a Scale | Standard Error 0.71 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 449 (n=368, 156) | 7.27 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 6.58 Units on a Scale | Standard Error 1.08 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 449 (n=368, 156) | 6.45 Units on a Scale | Standard Error 0.89 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 6.03 Units on a Scale | Standard Error 0.93 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 813 (n=323, 146) | 5.72 Units on a Scale | Standard Error 0.93 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 6.97 Units on a Scale | Standard Error 1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 6.51 Units on a Scale | Standard Error 1.01 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 6.65 Units on a Scale | Standard Error 1.57 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 7.10 Units on a Scale | Standard Error 1.6 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 365 (n=373, 159) | 5.31 Units on a Scale | Standard Error 0.78 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 6.49 Units on a Scale | Standard Error 0.88 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 7.38 Units on a Scale | Standard Error 0.96 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 7.29 Units on a Scale | Standard Error 0.96 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 5.81 Units on a Scale | Standard Error 0.99 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,177 (n=273, 125) | 7.02 Units on a Scale | Standard Error 1.07 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 6.14 Units on a Scale | Standard Error 1.03 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 7.01 Units on a Scale | Standard Error 1.25 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 7.13 Units on a Scale | Standard Error 1.1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 6.56 Units on a Scale | Standard Error 1.09 |
Secondary
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 365 (n=370, 157) | 9.70 Units on a Scale | Standard Error 0.5 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,093 (n=308, 137) | 10.83 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 729 (n=338, 146) | 10.71 Units on a Scale | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,177 (n=273, 124) | 11.02 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 533 (n=355, 155) | 10.27 Units on a Scale | Standard Error 0.51 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,261 (n=289, 133) | 10.40 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 9.81 Units on a Scale | Standard Error 0.87 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 813 (n=323, 145) | 10.79 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,457 (n=288, 128) | 11.12 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 449 (n=362, 156) | 10.51 Units on a Scale | Standard Error 0.5 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,625 (n=278, 125) | 10.76 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 897 (n=320, 139) | 10.30 Units on a Scale | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 10.81 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 617 (n=348, 153) | 10.46 Units on a Scale | Standard Error 0.52 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 11.69 Units on a Scale | Standard Error 0.93 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 981 (n=312, 136) | 11.05 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 9.69 Units on a Scale | Standard Error 0.99 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 981 (n=312, 136) | 10.78 Units on a Scale | Standard Error 0.87 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 11.39 Units on a Scale | Standard Error 1.71 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 365 (n=370, 157) | 6.61 Units on a Scale | Standard Error 0.74 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 449 (n=362, 156) | 9.91 Units on a Scale | Standard Error 0.78 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 533 (n=355, 155) | 10.53 Units on a Scale | Standard Error 0.86 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 617 (n=348, 153) | 10.74 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 729 (n=338, 146) | 10.36 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 813 (n=323, 145) | 10.41 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 897 (n=320, 139) | 9.87 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,261 (n=289, 133) | 11.34 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,093 (n=308, 137) | 11.07 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,177 (n=273, 124) | 11.20 Units on a Scale | Standard Error 1.01 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 10.81 Units on a Scale | Standard Error 1.55 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,457 (n=288, 128) | 10.68 Units on a Scale | Standard Error 0.97 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,625 (n=278, 125) | 11.05 Units on a Scale | Standard Error 0.9 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 10.09 Units on a Scale | Standard Error 0.91 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 9.65 Units on a Scale | Standard Error 1.47 |
Secondary
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 10.17 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 9.95 Units on a Scale | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 9.74 Units on a Scale | Standard Error 0.71 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 10.23 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 8.61 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,093 (n=310, 138) | 9.40 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 9.18 Units on a Scale | Standard Error 1 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 9.44 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,261 (n=292, 135) | 9.95 Units on a Scale | Standard Error 0.68 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 10.55 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 9.43 Units on a Scale | Standard Error 0.59 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 9.43 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 9.48 Units on a Scale | Standard Error 0.75 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 9.51 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 11.35 Units on a Scale | Standard Error 1.17 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 10.06 Units on a Scale | Standard Error 1.22 |
| ABA + MTX DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 9.80 Units on a Scale | Standard Error 0.72 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 10.90 Units on a Scale | Standard Error 2.25 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 9.80 Units on a Scale | Standard Error 0.98 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 9.68 Units on a Scale | Standard Error 1.13 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 9.22 Units on a Scale | Standard Error 1.92 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 6.44 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 9.13 Units on a Scale | Standard Error 0.93 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 9.63 Units on a Scale | Standard Error 1.03 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 9.71 Units on a Scale | Standard Error 1.06 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 9.39 Units on a Scale | Standard Error 1.07 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 10.45 Units on a Scale | Standard Error 1.1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,093 (n=310, 138) | 10.35 Units on a Scale | Standard Error 1.15 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 10.57 Units on a Scale | Standard Error 1.17 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,261 (n=292, 135) | 9.92 Units on a Scale | Standard Error 1.14 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 10.75 Units on a Scale | Standard Error 1.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 10.03 Units on a Scale | Standard Error 1.15 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 9.08 Units on a Scale | Standard Error 1.1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 9.46 Units on a Scale | Standard Error 0.97 |
Secondary
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 365 (n= 370, 158) | 8.97 Units on a Scale | Standard Error 0.81 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 8.44 Units on a Scale | Standard Error 0.88 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 897 (n=320, 139) | 8.48 Units on a Scale | Standard Error 0.9 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,093 (n=309, 137) | 9.31 Units on a Scale | Standard Error 0.94 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,261 (n=291, 133) | 8.43 Units on a Scale | Standard Error 1 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,625 (n=279, 125) | 7.91 Units on a Scale | Standard Error 1.02 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 7.39 Units on a Scale | Standard Error 0.71 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 7.81 Units on a Scale | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 7.06 Units on a Scale | Standard Error 1.69 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 449 (n=365, 157) | 8.02 Units on a Scale | Standard Error 0.86 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 8.60 Units on a Scale | Standard Error 0.88 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 8.96 Units on a Scale | Standard Error 0.86 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 813 (n=324, 146) | 8.71 Units on a Scale | Standard Error 0.89 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 981 (n=312, 136) | 8.61 Units on a Scale | Standard Error 0.92 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,177 (n=275, 124) | 8.35 Units on a Scale | Standard Error 1.01 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 7.22 Units on a Scale | Standard Error 1.35 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,457 (n=289, 128) | 7.51 Units on a Scale | Standard Error 0.98 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 365 (n= 370, 158) | 8.60 Units on a Scale | Standard Error 1.25 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 813 (n=324, 146) | 11.04 Units on a Scale | Standard Error 1.37 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 449 (n=365, 157) | 10.80 Units on a Scale | Standard Error 1.28 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 897 (n=320, 139) | 11.67 Units on a Scale | Standard Error 1.41 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 981 (n=312, 136) | 11.70 Units on a Scale | Standard Error 1.42 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 10.13 Units on a Scale | Standard Error 1.3 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,177 (n=275, 124) | 11.17 Units on a Scale | Standard Error 1.48 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,261 (n=291, 133) | 10.53 Units on a Scale | Standard Error 1.42 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,457 (n=289, 128) | 10.70 Units on a Scale | Standard Error 1.46 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 10.47 Units on a Scale | Standard Error 1.34 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,625 (n=279, 125) | 9.44 Units on a Scale | Standard Error 1.53 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,093 (n=309, 137) | 9.46 Units on a Scale | Standard Error 1.41 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,821 (n=273, 124) | 6.56 Units on a Scale | Standard Error 1.09 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 10.89 Units on a Scale | Standard Error 1.34 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,989 (n=118, 54) | 12.49 Units on a Scale | Standard Error 2.18 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 1,345 (n=146, 60) | 11.41 Units on a Scale | Standard Error 2.23 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 16.08 Units on a Scale | Standard Error 2.17 |
Secondary
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 365 (n=372, 160) | 10.10 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 10.66 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 11.18 Units on a Scale | Standard Error 0.7 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 10.93 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 11.33 Units on a Scale | Standard Error 0.72 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 10.56 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 10.13 Units on a Scale | Standard Error 0.74 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 10.96 Units on a Scale | Standard Error 0.76 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,093 (n=309, 138) | 11.82 Units on a Scale | Standard Error 0.76 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 11.32 Units on a Scale | Standard Error 0.82 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 10.25 Units on a Scale | Standard Error 0.82 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 9.09 Units on a Scale | Standard Error 1.13 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 10.57 Units on a Scale | Standard Error 0.79 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 10.11 Units on a Scale | Standard Error 0.8 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 11.25 Units on a Scale | Standard Error 0.84 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 10.79 Units on a Scale | Standard Error 1.31 |
| ABA + MTX DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 9.04 Units on a Scale | Standard Error 1.41 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,625 (n=279, 126) | 11.10 Units on a Scale | Standard Error 1.1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 365 (n=372, 160) | 7.59 Units on a Scale | Standard Error 0.96 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 11.09 Units on a Scale | Standard Error 1.18 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 449 (n=367, 157) | 10.89 Units on a Scale | Standard Error 1.04 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 10.96 Units on a Scale | Standard Error 1.06 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 10.98 Units on a Scale | Standard Error 1.02 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 11.61 Units on a Scale | Standard Error 1.08 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 11.61 Units on a Scale | Standard Error 1.05 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 10.62 Units on a Scale | Standard Error 1.15 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 11.50 Units on a Scale | Standard Error 1.04 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,345 (n=147, 61) | 10.32 Units on a Scale | Standard Error 1.67 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 10.57 Units on a Scale | Standard Error 1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 2,185 (n=84, 38) | 12.84 Units on a Scale | Standard Error 1.96 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 11.39 Units on a Scale | Standard Error 1.13 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 10.88 Units on a Scale | Standard Error 1.07 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 10.42 Units on a Scale | Standard Error 1.71 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period | Day 1,093 (n=309, 138) | 9.72 Units on a Scale | Standard Error 1.04 |
Secondary
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 9.01 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 449 (n=368, 157) | 9.74 Units on a Scale | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 9.88 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 9.48 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 9.80 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 9.96 Units on a Scale | Standard Error 0.67 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 10.16 Units on a Scale | Standard Error 0.68 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 9.01 Units on a Scale | Standard Error 1.11 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 10.16 Units on a Scale | Standard Error 0.72 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 9.67 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 8.93 Units on a Scale | Standard Error 0.75 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 7.98 Units on a Scale | Standard Error 1.31 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 9.99 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 9.71 Units on a Scale | Standard Error 0.66 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 9.28 Units on a Scale | Standard Error 0.71 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 9.54 Units on a Scale | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 9.34 Units on a Scale | Standard Error 1.17 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 9.05 Units on a Scale | Standard Error 0.99 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 8.61 Units on a Scale | Standard Error 0.98 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 449 (n=368, 157) | 9.47 Units on a Scale | Standard Error 0.91 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 10.17 Units on a Scale | Standard Error 1.37 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 533 (n=355, 157) | 9.44 Units on a Scale | Standard Error 0.92 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 9.92 Units on a Scale | Standard Error 0.99 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 10.57 Units on a Scale | Standard Error 1.4 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 813 (n=324, 147) | 8.97 Units on a Scale | Standard Error 0.92 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 365 (n=373, 160) | 7.12 Units on a Scale | Standard Error 0.77 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 9.81 Units on a Scale | Standard Error 0.99 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 9.51 Units on a Scale | Standard Error 1 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 617 (n=348, 156) | 8.66 Units on a Scale | Standard Error 0.92 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,177 (n=275, 125) | 9.64 Units on a Scale | Standard Error 1.06 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 8.84 Units on a Scale | Standard Error 1.42 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 729 (n=338, 148) | 9.90 Units on a Scale | Standard Error 0.94 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,457 (n=289, 129) | 9.26 Units on a Scale | Standard Error 1.01 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 8.16 Units on a Scale | Standard Error 0.91 |
Secondary
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 365 (n=373, 159) | 8.58 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 8.69 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 8.69 Units on a Scale | Standard Error 0.57 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 8.98 Units on a Scale | Standard Error 0.56 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,177 (n=273, 125) | 9.08 Units on a Scale | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 8.39 Units on a Scale | Standard Error 0.64 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 8.29 Units on a Scale | Standard Error 0.91 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 8.96 Units on a Scale | Standard Error 0.66 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 7.60 Units on a Scale | Standard Error 0.99 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 449 (n=368, 156) | 8.29 Units on a Scale | Standard Error 0.55 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 8.68 Units on a Scale | Standard Error 0.52 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 8.61 Units on a Scale | Standard Error 0.53 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 813 (n=323, 146) | 8.99 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 8.85 Units on a Scale | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 9.19 Units on a Scale | Standard Error 0.62 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 8.77 Units on a Scale | Standard Error 0.64 |
| ABA + MTX DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 7.06 Units on a Scale | Standard Error 1.11 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,261 (n=292, 134) | 8.14 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 365 (n=373, 159) | 6.04 Units on a Scale | Standard Error 0.68 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 449 (n=368, 156) | 8.70 Units on a Scale | Standard Error 0.76 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 729 (n=338, 147) | 8.41 Units on a Scale | Standard Error 0.8 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 813 (n=323, 146) | 8.22 Units on a Scale | Standard Error 0.83 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,345 (n=147, 62) | 6.39 Units on a Scale | Standard Error 1.25 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 897 (n=320, 140) | 8.53 Units on a Scale | Standard Error 0.81 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 533 (n=355, 156) | 8.09 Units on a Scale | Standard Error 0.81 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,093 (n=312, 138) | 7.53 Units on a Scale | Standard Error 0.82 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,989 (n=118, 55) | 7.99 Units on a Scale | Standard Error 1.26 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,177 (n=273, 125) | 8.08 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 617 (n=348, 155) | 8.46 Units on a Scale | Standard Error 0.79 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,457 (n=290, 129) | 7.57 Units on a Scale | Standard Error 0.87 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,625 (n=280, 126) | 8.20 Units on a Scale | Standard Error 0.85 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 2,185 (n=85, 38) | 9.61 Units on a Scale | Standard Error 1.28 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 1,821 (n=273, 125) | 7.42 Units on a Scale | Standard Error 0.84 |
| MTX + Placebo DB | Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period | Day 981 (n=312, 137) | 7.52 Units on a Scale | Standard Error 0.83 |
Secondary
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Change from baseline in participant were calculated at all study visits in the DB and OL periods.
Time frame: BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 57 (n=362, 153) | -1.80 mg / mL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 729 (n=333, 145) | -3.10 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 225 (n=361, 155) | -2.72 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 813 (n=313, 140) | -3.09 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 113 (n=362, 149) | -2.30 mg / mL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 897 (n=301, 133) | -3.06 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 281 (n=359, 156) | -2.81 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 981 (n=294, 131) | -3.21 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 29 (n=357, 154) | -1.27 mg / mL | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,093 (n=296, 127) | -3.21 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 365 (n=365, 156) | -2.83 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,177 (n=156, 70) | -3.27 mg / mL | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 141 (n=361, 155) | -2.46 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,261 (n=267, 117) | -3.22 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 449 (n=352, 147) | -2.91 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,457 (n=281, 126) | -3.29 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 85 (n=362, 149) | -2.12 mg / mL | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,625 (n=269, 121) | -3.23 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 533 (n=338, 147) | -3.01 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,821 (n=267, 122) | -3.14 mg / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 169 (n=366, 156) | -2.48 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,989 (n=118, 53) | -3.39 mg / mL | Standard Error 0.12 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 617 (n=329, 150) | -3.00 mg / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 2,185 (n=82, 36) | -3.04 mg / mL | Standard Error 0.16 |
| ABA + MTX DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 15 (n=352, 150) | -0.83 mg / mL | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 2,185 (n=82, 36) | -3.30 mg / mL | Standard Error 0.23 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 15 (n=352, 150) | -0.47 mg / mL | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 29 (n=357, 154) | -0.87 mg / mL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 57 (n=362, 153) | -1.17 mg / mL | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 85 (n=362, 149) | -1.37 mg / mL | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 113 (n=362, 149) | -1.47 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 141 (n=361, 155) | -1.52 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 169 (n=366, 156) | -1.57 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 225 (n=361, 155) | -1.70 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 281 (n=359, 156) | -1.87 mg / mL | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 365 (n=365, 156) | -1.68 mg / mL | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 449 (n=352, 147) | -2.68 mg / mL | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 533 (n=338, 147) | -2.79 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 617 (n=329, 150) | -2.92 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 729 (n=333, 145) | -3.02 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 813 (n=313, 140) | -3.05 mg / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 897 (n=301, 133) | -3.11 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 981 (n=294, 131) | -3.14 mg / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,093 (n=296, 127) | -3.15 mg / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,177 (n=156, 70) | -3.21 mg / mL | Standard Error 0.16 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,261 (n=267, 117) | -3.15 mg / mL | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,457 (n=281, 126) | -3.23 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,625 (n=269, 121) | -3.34 mg / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,821 (n=267, 122) | -3.26 mg / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period | Day 1,989 (n=118, 53) | -3.31 mg / mL | Standard Error 0.19 |
Secondary
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 981 (n=282, 119) | -3.26 IU / mL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 365 (n=352, 148) | -2.96 IU / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,177 (n=241, 110) | -3.33 IU / mL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 729 (n=315, 139) | -3.27 IU / mL | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,261 (n=271, 121) | -3.25 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 533 (n=332, 146) | -3.14 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,457 (n=269, 117) | -3.32 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 813 (n=303, 134) | -3.13 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,625 (n=260, 118) | -3.30 IU / mL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 449 (n=345, 145) | -3.04 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,821 (n=259, 114) | -3.22 IU / mL | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 897 (n=296, 128) | -3.11 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,989 (n=108, 47) | -3.41 IU / mL | Standard Error 0.13 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,093 (n=287, 130) | -3.23 IU / mL | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 2,185 (n=76, 31) | -3.25 IU / mL | Standard Error 0.17 |
| ABA + MTX DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 617 (n=325, 148) | -3.17 IU / mL | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 2,185 (n=76, 31) | -3.66 IU / mL | Standard Error 0.33 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 365 (n=352, 148) | -1.76 IU / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 449 (n=345, 145) | -2.87 IU / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 533 (n=332, 146) | -2.95 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 617 (n=325, 148) | -3.02 IU / mL | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 729 (n=315, 139) | -3.20 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 813 (n=303, 134) | -3.18 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 897 (n=296, 128) | -3.10 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,093 (n=287, 130) | -3.22 IU / mL | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,177 (n=241, 110) | -3.29 IU / mL | Standard Error 0.15 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,261 (n=271, 121) | -3.18 IU / mL | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,457 (n=269, 117) | -3.23 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,625 (n=260, 118) | -3.27 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,821 (n=259, 114) | -3.34 IU / mL | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 1,989 (n=108, 47) | -3.42 IU / mL | Standard Error 0.23 |
| MTX + Placebo DB | Mean Change From BL in DAS-28 ESR Over Time in the OL Period | Day 981 (n=282, 119) | -3.19 IU / mL | Standard Error 0.14 |
Secondary
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | E-Selectin Day 169 (n= 256, 126) | -13.8 ng / mL | Standard Error 3.28 |
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | MMP3 Day 169 (n=362, 183) | -37.2 ng / mL | Standard Error 2.85 |
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | MMP3 Day 365 (n=232, 112) | -41.0 ng / mL | Standard Error 4.09 |
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | E-Selectin Day 365 (n=162, 74) | -15.4 ng / mL | Standard Error 4.37 |
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | SICAM-1 Day 169 (n=264, 130) | -65.0 ng / mL | Standard Error 9.87 |
| ABA + MTX DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | SICAM-1 Day 365 (n=235, 114) | -80.0 ng / mL | Standard Error 27.2 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | SICAM-1 Day 169 (n=264, 130) | -42.0 ng / mL | Standard Error 17.02 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | MMP3 Day 365 (n=232, 112) | -12.1 ng / mL | Standard Error 5.01 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | E-Selectin Day 169 (n= 256, 126) | -6.52 ng / mL | Standard Error 4.44 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | SICAM-1 Day 365 (n=235, 114) | -43.7 ng / mL | Standard Error 16.25 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | MMP3 Day 169 (n=362, 183) | -8.03 ng / mL | Standard Error 3.88 |
| MTX + Placebo DB | Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period | E-Selectin Day 365 (n=162, 74) | -9.94 ng / mL | Standard Error 5.73 |
Secondary
Mean Change From BL in ESR in the OL Period
Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.
Time frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 1,093 (n=283, 123) | -17.2 IU / mL | Standard Error 1.55 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 1,821 (n=257, 109) | -17.7 IU / mL | Standard Error 1.46 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 729 (n=307, 132) | -19.3 IU / mL | Standard Error 1.29 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 1,989 (n=114, 49) | -17.3 IU / mL | Standard Error 2.33 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 1,457 (n=270, 111) | -17.7 IU / mL | Standard Error 1.41 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 2,185 (n=76, 29) | -22.1 IU / mL | Standard Error 2.92 |
| ABA + MTX DB | Mean Change From BL in ESR in the OL Period | Day 365 (n=343, 141) | -17.9 IU / mL | Standard Error 1.21 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 2,185 (n=76, 29) | -21.0 IU / mL | Standard Error 4.45 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 365 (n=343, 141) | -6.85 IU / mL | Standard Error 1.74 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 729 (n=307, 132) | -16.3 IU / mL | Standard Error 1.91 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 1,093 (n=283, 123) | -16.6 IU / mL | Standard Error 2.15 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 1,457 (n=270, 111) | -16.3 IU / mL | Standard Error 2.33 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 1,821 (n=257, 109) | -16.6 IU / mL | Standard Error 2.26 |
| MTX + Placebo DB | Mean Change From BL in ESR in the OL Period | Day 1,989 (n=114, 49) | -13.3 IU / mL | Standard Error 3.12 |
Secondary
Mean Change From BL in Fatigue in the OL Period
The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 365 (n=373, 160) | -28.0 Units on a Scale | Standard Error 1.49 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 729 (n=329, 143) | -31.2 Units on a Scale | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 813 (n=318, 141) | -29.9 Units on a Scale | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 897 (n=316, 139) | -29.7 Units on a Scale | Standard Error 1.66 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,093 (n=307, 138) | -32.8 Units on a Scale | Standard Error 1.61 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,625 (n=275, 124) | -30.9 Units on a Scale | Standard Error 1.69 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,821 (n=263, 125) | -30.3 Units on a Scale | Standard Error 1.82 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,989 (n=115, 53) | -33.6 Units on a Scale | Standard Error 2.8 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 2,185 (n=81, 37) | -29.4 Units on a Scale | Standard Error 3.22 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 449 (n=358, 156) | -28.5 Units on a Scale | Standard Error 1.55 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 533 (n=353, 157) | -29.4 Units on a Scale | Standard Error 1.51 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 617 (n=339, 150) | -30.4 Units on a Scale | Standard Error 1.6 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 981 (n=312, 137) | -30.5 Units on a Scale | Standard Error 1.69 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,177 (n=271, 123) | -32.2 Units on a Scale | Standard Error 1.83 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,261 (n=289, 133) | -30.3 Units on a Scale | Standard Error 1.7 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,345 (n=141, 59) | -33.9 Units on a Scale | Standard Error 2.42 |
| ABA + MTX DB | Mean Change From BL in Fatigue in the OL Period | Day 1,457 (n=283, 129) | -32.2 Units on a Scale | Standard Error 1.65 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,261 (n=289, 133) | -31.2 Units on a Scale | Standard Error 2.62 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 617 (n=339, 150) | -30.5 Units on a Scale | Standard Error 2.54 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 2,185 (n=81, 37) | -35.0 Units on a Scale | Standard Error 4.49 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 729 (n=329, 143) | -30.0 Units on a Scale | Standard Error 2.67 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 365 (n=373, 160) | -22.6 Units on a Scale | Standard Error 2.21 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 813 (n=318, 141) | -31.0 Units on a Scale | Standard Error 2.42 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,457 (n=283, 129) | -32.6 Units on a Scale | Standard Error 2.62 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 897 (n=316, 139) | -30.6 Units on a Scale | Standard Error 2.45 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 981 (n=312, 137) | -31.1 Units on a Scale | Standard Error 2.56 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 449 (n=358, 156) | -31.1 Units on a Scale | Standard Error 2.43 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,093 (n=307, 138) | -31.3 Units on a Scale | Standard Error 2.53 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,177 (n=271, 123) | -33.3 Units on a Scale | Standard Error 2.69 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,625 (n=275, 124) | -32.3 Units on a Scale | Standard Error 2.56 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 533 (n=353, 157) | -31.1 Units on a Scale | Standard Error 2.46 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,821 (n=263, 125) | -32.0 Units on a Scale | Standard Error 2.65 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,345 (n=141, 59) | -28.2 Units on a Scale | Standard Error 3.8 |
| MTX + Placebo DB | Mean Change From BL in Fatigue in the OL Period | Day 1,989 (n=115, 53) | -33.7 Units on a Scale | Standard Error 4.18 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,093
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Dressing and Grooming (n=310, 138) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Hygiene (n=310, 137) | -0.58 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Eating (n=309, 138) | -0.81 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Reaching (n=310, 137) | -0.79 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Arising (n=309, 138) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Gripping (n=310, 137) | -0.71 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Walking (n=308, 137) | -0.70 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Activities (n=310, 137) | -0.71 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | HAQ DI (n=308, 137) | -0.74 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Activities (n=310, 137) | -0.73 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | HAQ DI (n=308, 137) | -0.76 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Dressing and Grooming (n=310, 138) | -0.91 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Arising (n=309, 138) | -0.87 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Eating (n=309, 138) | -0.70 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Walking (n=308, 137) | -0.69 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Hygiene (n=310, 137) | -0.59 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Reaching (n=310, 137) | -0.81 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period | Gripping (n=310, 137) | -0.74 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,177
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Arising (n=274, 125) | -0.74 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Hygiene (n=275, 124) | -0.57 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Dressing and Grooming (n=274, 125) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Reaching (n=275, 125) | -0.82 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Eating (n=274, 125) | -0.92 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Gripping (n=275, 125) | -0.80 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Walking (n=272, 122) | -0.63 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Activities (n=275, 125) | -0.75 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | HAQ DI (n=274, 125) | -0.76 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Activities (n=275, 125) | -0.76 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | HAQ DI (n=274, 125) | -0.74 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Dressing and Grooming (n=274, 125) | -0.86 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Arising (n=274, 125) | -0.79 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Eating (n=274, 125) | -0.74 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Walking (n=272, 122) | -0.66 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Hygiene (n=275, 124) | -0.48 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Reaching (n=275, 125) | -0.84 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period | Gripping (n=275, 125) | -0.80 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,261
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Dressing and Grooming (n=292, 135) | -0.81 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Hygiene (n=292, 134) | -0.52 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Eating (n=292, 135) | -0.85 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Reaching (n=292, 134) | -0.83 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Arising (n=292, 135) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Gripping (n=292, 134) | -0.68 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Walking (n=290, 134) | -0.66 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Activities (n=292, 133) | -0.75 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | HAQ DI (n=292, 134) | -0.74 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Activities (n=292, 133) | -0.68 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | HAQ DI (n=292, 134) | -0.73 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Dressing and Grooming (n=292, 135) | -0.91 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Arising (n=292, 135) | -0.82 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Eating (n=292, 135) | -0.73 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Walking (n=290, 134) | -0.63 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Hygiene (n=292, 134) | -0.54 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Reaching (n=292, 134) | -0.80 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period | Gripping (n=292, 134) | -0.70 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,345
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Dressing and Grooming (n=152, 62) | -0.74 Units on a Scale | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Hygiene (n=152, 62) | -0.46 Units on a Scale | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Eating (n=152, 62) | -0.84 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Reaching (n=152, 62) | -0.84 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Arising (n=152, 62) | -0.68 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Gripping (n=152, 62) | -0.63 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Walking (n=151, 62) | -0.61 Units on a Scale | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Activities (n=152, 62) | -0.73 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | HAQ DI (n=152, 62) | -0.69 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Activities (n=152, 62) | -0.60 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | HAQ DI (n=152, 62) | -0.73 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Dressing and Grooming (n=152, 62) | -0.81 Units on a Scale | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Arising (n=152, 62) | -0.84 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Eating (n=152, 62) | -0.68 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Walking (n=151, 62) | -0.60 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Hygiene (n=152, 62) | -0.71 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Reaching (n=152, 62) | -0.76 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period | Gripping (n=152, 62) | -0.82 Units on a Scale | Standard Error 0.11 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,457
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Dressing and Grooming (n=289, 129) | -0.85 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Hygiene (n=289, 129) | -0.57 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Eating (n=289, 129) | -0.89 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Reaching (n=289, 129) | -0.84 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Arising (n=289, 129) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Gripping (n=289, 129) | -0.77 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Walking (n=287, 126) | -0.68 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Activities (n=289, 129) | -0.77 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | HAQ DI (n=289, 129) | -0.77 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Activities (n=289, 129) | -0.74 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | HAQ DI (n=289, 129) | -0.74 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Dressing and Grooming (n=289, 129) | -0.91 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Arising (n=289, 129) | -0.82 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Eating (n=289, 129) | -0.81 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Walking (n=287, 126) | -0.63 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Hygiene (n=289, 129) | -0.59 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Reaching (n=289, 129) | -0.76 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period | Gripping (n=289, 129) | -0.71 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,625
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Dressing and Grooming (n=280, 126) | -0.84 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Hygiene (n=280, 126) | -0.56 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Eating (n=280, 126) | -0.83 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Reaching (n=280, 126) | -0.83 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Arising (n=280, 126) | -0.79 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Gripping (n=280, 126) | -0.80 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Walking (n=279, 125) | -0.70 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Activities (n=280, 126) | -0.78 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | HAQ DI (n=280, 126) | -0.76 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Activities (n=280, 126) | -0.76 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | HAQ DI (n=280, 126) | -0.78 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Dressing and Grooming (n=280, 126) | -0.98 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Arising (n=280, 126) | -0.84 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Eating (n=280, 126) | -0.79 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Walking (n=279, 125) | -0.74 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Hygiene (n=280, 126) | -0.57 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Reaching (n=280, 126) | -0.81 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period | Gripping (n=280, 126) | -0.76 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Dressing and Grooming (n=273, 125) | -0.82 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Hygiene (n=273, 125) | -0.56 Units on a Scale | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Eating (n=273, 124) | -0.86 Units on a Scale | Standard Error 0.07 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Reaching (n=273, 125) | -0.83 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Arising (n=273, 125) | -0.83 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Gripping (n=273, 125) | -0.79 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Walking (n=271, 122) | -0.68 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Activities (n=273, 125) | -0.76 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | HAQ DI (n=273, 125) | -0.77 Units on a Scale | Standard Error 0.44 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Activities (n=273, 125) | -0.61 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | HAQ DI (n=273, 125) | -0.72 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Dressing and Grooming (n=273, 125) | -0.86 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Arising (n=273, 125) | -0.90 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Eating (n=273, 124) | -0.78 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Walking (n=271, 122) | -0.61 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Hygiene (n=273, 125) | -0.53 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Reaching (n=273, 125) | -0.74 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period | Gripping (n=273, 125) | -0.80 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 1,989
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Dressing and Grooming (n=119, 55) | -0.84 Units on a Scale | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Hygiene (n=119, 55) | -0.56 Units on a Scale | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Eating (n=119, 55) | -0.83 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Reaching (n=119, 55) | -0.89 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Arising (n=119, 55) | -0.86 Units on a Scale | Standard Error 0.08 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Gripping (n=119, 55) | -0.88 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Walking (n=117, 54) | -0.77 Units on a Scale | Standard Error 0.09 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Activities (n=119, 55) | -0.84 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | HAQ DI (n=119, 55) | -0.81 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Activities (n=119, 55) | -0.71 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | HAQ DI (n=119, 55) | -0.70 Units on a Scale | Standard Error 0.1 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Dressing and Grooming (n=119, 55) | -0.76 Units on a Scale | Standard Error 0.11 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Arising (n=119, 55) | -0.84 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Eating (n=119, 55) | -0.62 Units on a Scale | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Walking (n=117, 54) | -0.67 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Hygiene (n=119, 55) | -0.58 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Reaching (n=119, 55) | -0.75 Units on a Scale | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period | Gripping (n=119, 55) | -0.67 Units on a Scale | Standard Error 0.12 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Eating (n=85, 38) | -0.82 Units on a Scale | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Dressing and Grooming (n=85, 37) | -0.68 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Walking (n=84, 38) | -0.67 Units on a Scale | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Reaching (n=85, 38) | -0.88 Units on a Scale | Standard Error 0.12 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Hygiene (n=85, 38) | -0.55 Units on a Scale | Standard Error 0.13 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Gripping (n=85, 38) | -0.64 Units on a Scale | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Arising (n=85, 38) | -0.66 Units on a Scale | Standard Error 0.11 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Activities (n=85, 38) | -0.68 Units on a Scale | Standard Error 0.1 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | HAQ DI (n=85, 38) | -0.70 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Activities (n=85, 38) | -0.68 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Hygiene (n=85, 38) | -0.68 Units on a Scale | Standard Error 0.15 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Reaching (n=85, 38) | -0.66 Units on a Scale | Standard Error 0.17 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Dressing and Grooming (n=85, 37) | -0.78 Units on a Scale | Standard Error 0.13 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Arising (n=85, 38) | -0.82 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Eating (n=85, 38) | -0.74 Units on a Scale | Standard Error 0.16 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Walking (n=84, 38) | -0.58 Units on a Scale | Standard Error 0.14 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | Gripping (n=85, 38) | -0.47 Units on a Scale | Standard Error 0.12 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period | HAQ DI (n=85, 38) | -0.68 Units on a Scale | Standard Error 0.1 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 365
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Arising (n=372, 160) | -0.75 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Walking (n=372, 158) | -0.62 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Dressing and Grooming (n=372, 160) | -0.77 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Hygiene (n=370, 160) | -0.54 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Eating (n=372, 160) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Reaching (n=370, 160) | -0.71 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Gripping (n=371, 160) | -0.63 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Activities (n=369, 160) | -0.66 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | HAQ DI (n=369, 160) | -0.68 Units on a Scale | Standard Error 0.03 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Activities (n=369, 160) | -0.47 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | HAQ DI (n=369, 160) | -0.51 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Dressing and Grooming (n=372, 160) | -0.62 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Reaching (n=370, 160) | -0.60 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Gripping (n=371, 160) | -0.49 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Arising (n=372, 160) | -0.59 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Eating (n=372, 160) | -0.46 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Walking (n=372, 158) | -0.48 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period | Hygiene (n=370, 160) | -0.36 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 449
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | HAQ DI (n=366, 157) | -0.70 Units on a Scale | Standard Error 0.03 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Walking (n=367, 155) | -0.60 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Hygiene (n=367, 157) | -0.57 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Reaching (n= 367, 157) | -0.75 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Arising (n=367, 157) | -0.72 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Gripping (n=368, 157) | -0.67 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Eating (n=367, 157) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Activities (n=367, 157) | -0.70 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Dressing and Grooming (n=367, 157) | -0.78 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Activities (n=367, 157) | -0.65 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Dressing and Grooming (n=367, 157) | -0.85 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Hygiene (n=367, 157) | -0.59 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | HAQ DI (n=366, 157) | -0.71 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Arising (n=367, 157) | -0.86 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Eating (n=367, 157) | -0.63 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Walking (n=367, 155) | -0.61 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Reaching (n= 367, 157) | -0.76 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period | Gripping (n=368, 157) | -0.73 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 533
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | HAQ DI (n=354, 157) | -0.73 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Hygiene (n=354, 157) | -0.64 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Arising (n=355, 157) | -0.76 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Reaching (n=354, 157) | -0.77 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Eating (n=355, 156) | -0.83 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Gripping (n=354, 157) | -0.68 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Dressing and Grooming (n=355, 156) | -0.81 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Activities (n=354, 157) | -0.70 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Walking (n=351, 156) | -0.64 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Activities (n=354, 157) | -0.68 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | HAQ DI (n=354, 157) | -0.73 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Dressing and Grooming (n=355, 156) | -0.85 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Eating (n=355, 156) | -0.74 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Walking (n=351, 156) | -0.69 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Hygiene (n=354, 157) | -0.57 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Reaching (n=354, 157) | -0.57 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Gripping (n=354, 157) | -0.74 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period | Arising (n=355, 157) | -0.86 Units on a Scale | Standard Error 0.07 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 617
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Reaching (n=348, 155) | -0.81 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Eating (n=348, 155) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Dressing and Grooming (n=348, 155) | -0.76 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | HAQ DI (n=348, 154) | -0.73 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Hygiene (n=348, 155) | -0.56 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Gripping (n=348, 154) | -0.75 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Arising (n=348, 155) | -0.84 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Activities (n=348, 155) | -0.71 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Walking (n=348, 154) | -0.66 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Activities (n=348, 155) | -0.76 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Hygiene (n=348, 155) | -0.66 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Reaching (n=348, 155) | -0.80 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | HAQ DI (n=348, 154) | -0.74 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Dressing and Grooming (n=348, 155) | -0.82 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Arising (n=348, 155) | -0.81 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Eating (n=348, 155) | -0.75 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Walking (n=348, 154) | -0.67 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period | Gripping (n=348, 154) | -0.68 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 729
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | HAQ DI (n=337, 148) | -0.74 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Eating (n= 337, 148) | -0.81 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Activities (n=338, 148) | -0.72 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Walking (n=338, 147) | -0.68 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Dressing and Grooming (n=337, 148) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Hygiene (n=338, 148) | -0.53 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Reaching (n=336, 148) | -0.79 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Gripping (n=338, 148) | -0.75 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Arising (n=338, 148) | -0.80 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Gripping (n=338, 148) | -0.62 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Activities (n=338, 148) | -0.72 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | HAQ DI (n=337, 148) | -0.72 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Dressing and Grooming (n=337, 148) | -0.91 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Arising (n=338, 148) | -0.82 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Eating (n= 337, 148) | -0.72 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Walking (n=338, 147) | -0.63 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Reaching (n=336, 148) | -0.73 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period | Hygiene (n=338, 148) | -0.62 Units on a Scale | Standard Error 0.09 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 813
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | HAQ DI (n=325, 146) | -0.77 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Walking (n=324, 146) | -0.69 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Arising (n=325, 147) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Hygiene (n=325, 146) | -0.58 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Dressing and Grooming (n=325, 147) | -0.82 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Reaching (n=324, 146) | -0.85 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Eating (n=325, 147) | -0.88 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Gripping (n=325, 146) | -0.76 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Activities (n=324, 146) | -0.76 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Gripping (n=325, 146) | -0.77 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Activities (n=324, 146) | -0.71 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | HAQ DI (n=325, 146) | -0.71 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Dressing and Grooming (n=325, 147) | -0.87 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Arising (n=325, 147) | -0.78 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Eating (n=325, 147) | -0.72 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Walking (n=324, 146) | -0.66 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Hygiene (n=325, 146) | -0.53 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period | Reaching (n=324, 146) | -0.72 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 897
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Dressing and Grooming (n=319, 140) | -0.86 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Hygiene (n=319, 140) | -0.60 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Arising (n=319, 140) | -0.81 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Reaching (n=319, 140) | -0.82 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Eating (n=319, 140) | -0.88 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Gripping (n=319, 140) | -0.74 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | HAQ DI (n=318, 140) | -0.76 Units on a Scale | Standard Error 0.04 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Activities (n=319, 140) | -0.69 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Walking (n=319, 138) | -0.69 Units on a Scale | Standard Error 0.05 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Activities (n=319, 140) | -0.71 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Dressing and Grooming (n=319, 140) | -0.90 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Arising (n=319, 140) | -0.87 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Eating (n=319, 140) | -0.78 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Walking (n=319, 138) | -0.67 Units on a Scale | Standard Error 0.07 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Hygiene (n=319, 140) | -0.54 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Reaching (n=319, 140) | -0.74 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | Gripping (n=319, 140) | -0.74 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period | HAQ DI (n=318, 140) | -0.74 Units on a Scale | Standard Error 0.06 |
Secondary
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: BL (Day 0), Day 981
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Dressing and Grooming (n=312, 137) | -0.80 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Hygiene (n=312, 137) | -0.54 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Eating (n=312, 137) | -0.84 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Reaching (n=312, 137) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Arising (n=312, 137) | -0.82 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Gripping (n=312, 137) | -0.68 Units on a Scale | Standard Error 0.06 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Walking (n=308, 136) | -0.66 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Activities (n=312, 137) | -0.74 Units on a Scale | Standard Error 0.05 |
| ABA + MTX DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | HAQ DI (n=312, 137) | -0.74 Units on a Scale | Standard Error 0.04 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Activities (n=312, 137) | -0.64 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | HAQ DI (n=312, 137) | -0.69 Units on a Scale | Standard Error 0.06 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Dressing and Grooming (n=312, 137) | -0.86 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Arising (n=312, 137) | -0.77 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Eating (n=312, 137) | -0.64 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Walking (n=308, 136) | -0.63 Units on a Scale | Standard Error 0.08 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Hygiene (n=312, 137) | -0.49 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Reaching (n=312, 137) | -0.75 Units on a Scale | Standard Error 0.09 |
| MTX + Placebo DB | Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period | Gripping (n=312, 137) | -0.74 Units on a Scale | Standard Error 0.08 |
Secondary
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | IL-6 Day 169 (n=357, 175) | -21.0 pg / mL | Standard Error 2.24 |
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | SIL-2R Day 169 (n=370, 171) | -519.0 pg / mL | Standard Error 32.72 |
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | TNF-Alpha Day 169 (n=354, 172) | -0.82 pg / mL | Standard Error 0.72 |
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | IL-6 Day 365 (n=247, 121) | -23.4 pg / mL | Standard Error 3.08 |
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | SIL-2R Day 365(n=235, 106) | -562 pg / mL | Standard Error 40.82 |
| ABA + MTX DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | TNF-Alpha Day 365 (n=246, 119) | -0.22 pg / mL | Standard Error 1.04 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | SIL-2R Day 365(n=235, 106) | -290 pg / mL | Standard Error 87.97 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | IL-6 Day 169 (n=357, 175) | -5.81 pg / mL | Standard Error 3 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | IL-6 Day 365 (n=247, 121) | -1.82 pg / mL | Standard Error 5.23 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | SIL-2R Day 169 (n=370, 171) | -85.5 pg / mL | Standard Error 32.78 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | TNF-Alpha Day 365 (n=246, 119) | 1.22 pg / mL | Standard Error 2.42 |
| MTX + Placebo DB | Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period | TNF-Alpha Day 169 (n=354, 172) | 2.27 pg / mL | Standard Error 2.49 |
Secondary
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 981 (n=300, 129) | -9.48 Days | Standard Error 0.66 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,457 (n=196, 84) | -9.73 Days | Standard Error 0.94 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 617 (n=332, 140) | -9.49 Days | Standard Error 0.63 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,345 (n=133, 57) | -11.1 Days | Standard Error 1.02 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 365 (n=360, 153) | -9.04 Days | Standard Error 0.6 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,093 (n=292, 130) | -10.1 Days | Standard Error 0.69 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 449 (n=348, 150) | -8.75 Days | Standard Error 0.58 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 813 (n=306, 133) | -9.87 Days | Standard Error 0.64 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 533 (n=338, 148) | -9.21 Days | Standard Error 0.61 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 897 (n=302, 131) | -9.35 Days | Standard Error 0.65 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,177 (n=259, 118) | -10.6 Days | Standard Error 0.68 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,261 (n=231, 105) | -9.96 Days | Standard Error 0.73 |
| ABA + MTX DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 729 (n=316, 138) | -9.55 Days | Standard Error 0.62 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,261 (n=231, 105) | -8.30 Days | Standard Error 1.51 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 617 (n=332, 140) | -8.62 Days | Standard Error 1.18 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 729 (n=316, 138) | -8.18 Days | Standard Error 1.21 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 813 (n=306, 133) | -8.67 Days | Standard Error 1.19 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 981 (n=300, 129) | -8.68 Days | Standard Error 1.26 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,093 (n=292, 130) | -8.71 Days | Standard Error 1.25 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,177 (n=259, 118) | -8.39 Days | Standard Error 1.34 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,345 (n=133, 57) | -9.18 Days | Standard Error 1.61 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 1,457 (n=196, 84) | -10.3 Days | Standard Error 1.61 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 365 (n=360, 153) | -6.39 Days | Standard Error 1.04 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 449 (n=348, 150) | -8.60 Days | Standard Error 1.03 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 897 (n=302, 131) | -9.22 Days | Standard Error 1.28 |
| MTX + Placebo DB | Mean Change From BL in Limitations on Activities of Daily Living in the OL Period | Day 533 (n=338, 148) | -9.00 Days | Standard Error 1.12 |
Secondary
Mean Change From BL in RF in the DB Period
The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in RF in the DB Period | BL (Day 0) for Day 365 Cohort (n=281, 104) | -46.5 IU / mL | Standard Error 11.44 |
| ABA + MTX DB | Mean Change From BL in RF in the DB Period | BL (Day 0) for Day 169 Cohort (n=308, 126) | -49.8 IU / mL | Standard Error 10.9 |
| MTX + Placebo DB | Mean Change From BL in RF in the DB Period | BL (Day 0) for Day 169 Cohort (n=308, 126) | -18.6 IU / mL | Standard Error 10.28 |
| MTX + Placebo DB | Mean Change From BL in RF in the DB Period | BL (Day 0) for Day 365 Cohort (n=281, 104) | -5.83 IU / mL | Standard Error 22.38 |
Secondary
Mean Change From BL in Sleep Quality in the OL Period
The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
Time frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 365 (n=373, 160) | -10.8 Units on a Scale | Standard Error 0.91 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 449 (n=358, 156) | -11.0 Units on a Scale | Standard Error 0.97 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 533 (n=353, 157) | -11.4 Units on a Scale | Standard Error 0.92 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 617 (n=339, 150) | -10.6 Units on a Scale | Standard Error 0.92 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 729 (n=329, 143) | -10.9 Units on a Scale | Standard Error 0.99 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,177 (n=270, 124) | -11.9 Units on a Scale | Standard Error 1.19 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,261 (n=289, 133) | -12.2 Units on a Scale | Standard Error 1.16 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,457 (n=275, 124) | -11.7 Units on a Scale | Standard Error 1.16 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,821 (n=263, 125) | -10.8 Units on a Scale | Standard Error 1.23 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 2,185 (n=81, 37) | -8.76 Units on a Scale | Standard Error 2.03 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 813 (n=318, 141) | -10.9 Units on a Scale | Standard Error 1.07 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 897 (n=316, 139) | -12.2 Units on a Scale | Standard Error 1.04 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 981 (n=312, 137) | -11.4 Units on a Scale | Standard Error 1.05 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,093 (n=307, 138) | -11.9 Units on a Scale | Standard Error 1.09 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,345 (n=141, 59) | -11.6 Units on a Scale | Standard Error 1.68 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,625 (n=272, 122) | -11.2 Units on a Scale | Standard Error 1.19 |
| ABA + MTX DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,989 (n=115, 53) | -11.7 Units on a Scale | Standard Error 1.98 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 2,185 (n=81, 37) | -14.6 Units on a Scale | Standard Error 2.92 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 365 (n=373, 160) | -7.97 Units on a Scale | Standard Error 1.25 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 449 (n=358, 156) | -11.4 Units on a Scale | Standard Error 1.36 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 617 (n=339, 150) | -11.9 Units on a Scale | Standard Error 1.41 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 533 (n=353, 157) | -10.9 Units on a Scale | Standard Error 1.42 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 729 (n=329, 143) | -11.3 Units on a Scale | Standard Error 1.48 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,457 (n=275, 124) | -10.4 Units on a Scale | Standard Error 1.62 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,093 (n=307, 138) | -11.3 Units on a Scale | Standard Error 1.53 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 813 (n=318, 141) | -10.8 Units on a Scale | Standard Error 1.57 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,177 (n=270, 124) | -10.8 Units on a Scale | Standard Error 1.61 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,261 (n=289, 133) | -10.1 Units on a Scale | Standard Error 1.59 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,345 (n=141, 59) | -12.5 Units on a Scale | Standard Error 2.17 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 897 (n=316, 139) | -12.0 Units on a Scale | Standard Error 1.46 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,625 (n=272, 122) | -11.6 Units on a Scale | Standard Error 1.72 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,821 (n=263, 125) | -9.10 Units on a Scale | Standard Error 1.5 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 1,989 (n=115, 53) | -11.0 Units on a Scale | Standard Error 2.4 |
| MTX + Placebo DB | Mean Change From BL in Sleep Quality in the OL Period | Day 981 (n=312, 137) | -10.8 Units on a Scale | Standard Error 1.58 |
Secondary
Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.
Time frame: BL (Day 0), Day 169, Day 365
Population: All treated subjects in the DB period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 169 (n=370, 171) | -519.00 mg / mL | Standard Error 23.72 |
| ABA + MTX DB | Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 365 (n=235, 106) | -562.00 mg / mL | Standard Error 40.82 |
| MTX + Placebo DB | Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 169 (n=370, 171) | -85.50 mg / mL | Standard Error 32.78 |
| MTX + Placebo DB | Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period | Day 365 (n=235, 106) | -290.00 mg / mL | Standard Error 87.97 |
Secondary
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.
Time frame: BL (Day 0), Day 365
Population: All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Baseline Mean JSN | 22.79 Units on a Scale | Standard Deviation 20.16 |
| ABA + MTX DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Baseline Mean TS | 44.47 Units on a Scale | Standard Deviation 37.33 |
| ABA + MTX DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Mean Change From Baseline JSN Day 365 | 0.58 Units on a Scale | Standard Deviation 1.54 |
| ABA + MTX DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Mean Change From Baseline TS Day 365 | 1.21 Units on a Scale | Standard Deviation 2.94 |
| MTX + Placebo DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Mean Change From Baseline JSN Day 365 | 1.18 Units on a Scale | Standard Deviation 2.58 |
| MTX + Placebo DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Baseline Mean JSN | 23.02 Units on a Scale | Standard Deviation 20.36 |
| MTX + Placebo DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Mean Change From Baseline TS Day 365 | 2.32 Units on a Scale | Standard Deviation 5.04 |
| MTX + Placebo DB | Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) | Baseline Mean TS | 44.85 Units on a Scale | Standard Deviation 37.72 |
Secondary
Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.
Time frame: BL (Day 0)
Population: All randomized and treated participants in the DB period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Participant Physical Pain Assessment | 63.3 Units on a Scale | Standard Deviation 21.1 |
| ABA + MTX DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Participant Global Assessment | 62.7 Units on a Scale | Standard Deviation 21.2 |
| ABA + MTX DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Physician Global Assessment | 68.0 Units on a Scale | Standard Deviation 16 |
| MTX + Placebo DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Participant Physical Pain Assessment | 65.9 Units on a Scale | Standard Deviation 20.6 |
| MTX + Placebo DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Participant Global Assessment | 62.8 Units on a Scale | Standard Deviation 21.6 |
| MTX + Placebo DB | Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment | Physician Global Assessment | 67.4 Units on a Scale | Standard Deviation 17 |
Secondary
Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Time frame: BL (Day 0), Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) | BL (Day 0) for Day 169 Cohort (n= 416, 207) | 30.49 Units on a Scale | Standard Deviation 7.18 |
| ABA + MTX DB | Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) | BL (Day 0) for Day 365 Cohort (n=417, 207) | 30.51 Units on a Scale | Standard Deviation 7.17 |
| MTX + Placebo DB | Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) | BL (Day 0) for Day 169 Cohort (n= 416, 207) | 30.61 Units on a Scale | Standard Deviation 7.42 |
| MTX + Placebo DB | Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) | BL (Day 0) for Day 365 Cohort (n=417, 207) | 30.62 Units on a Scale | Standard Deviation 7.42 |
Secondary
Mean Number of Tender Joints and Swollen Joints at DB BL
Time frame: BL (Day 0)
Population: All randomized and treated participants in the DB period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABA + MTX DB | Mean Number of Tender Joints and Swollen Joints at DB BL | Swollen Joints | 21.4 Joints | Standard Deviation 8.8 |
| ABA + MTX DB | Mean Number of Tender Joints and Swollen Joints at DB BL | Tender Joints | 31.0 Joints | Standard Deviation 13.2 |
| MTX + Placebo DB | Mean Number of Tender Joints and Swollen Joints at DB BL | Tender Joints | 32.3 Joints | Standard Deviation 13.6 |
| MTX + Placebo DB | Mean Number of Tender Joints and Swollen Joints at DB BL | Swollen Joints | 22.1 Joints | Standard Deviation 8.8 |
Secondary
Number of ACR 20 Responders in the DB and OL Periods
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 29 (n = 368, n=158) | 145 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 617 (n = 347, n = 155) | 299 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 729 (n = 337, n = 147) | 296 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 169 (n = 371, n = 159) | 272 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 813 (n = 322, n = 143) | 273 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 85 (n = 367, n = 158) | 246 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 897 (n = 311, n = 136) | 260 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 225 (n = 369, n = 158) | 302 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 981 (n = 298, n = 133) | 243 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,093 (n = 303, n = 134) | 257 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 15 (n = 370, n = 158) | 95 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,177 (n = 265, n = 117) | 228 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 281 (n = 367, n = 159) | 299 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 131) | 251 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 113 (n = 367, n = 159) | 266 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,345 (n = 133, n = 53) | 108 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 365 (n = 373, n = 159) | 307 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 128) | 253 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 57 (n = 371, n = 159) | 218 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,625 (n = 273, n= 126) | 236 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,821 (n = 268, n = 123) | 224 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 449 (n = 363, n = 155) | 299 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,989 (n = 119, n = 54) | 103 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 141 (n = 368, n = 159) | 275 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 2,185 (n = 85, n = 37) | 72 Participants |
| ABA + MTX DB | Number of ACR 20 Responders in the DB and OL Periods | Day 533 (n = 353, n = 155) | 300 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 533 (n = 353, n = 155) | 127 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 981 (n = 298, n = 133) | 110 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,625 (n = 273, n= 126) | 112 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 15 (n = 370, n = 158) | 26 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 29 (n = 368, n=158) | 44 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 57 (n = 371, n = 159) | 66 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 85 (n = 367, n = 158) | 70 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 113 (n = 367, n = 159) | 79 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 141 (n = 368, n = 159) | 85 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 169 (n = 371, n = 159) | 79 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 225 (n = 369, n = 158) | 86 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 281 (n = 367, n = 159) | 92 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 365 (n = 373, n = 159) | 86 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 449 (n = 363, n = 155) | 122 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 617 (n = 347, n = 155) | 127 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 729 (n = 337, n = 147) | 122 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 813 (n = 322, n = 143) | 124 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 897 (n = 311, n = 136) | 117 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,093 (n = 303, n = 134) | 111 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,177 (n = 265, n = 117) | 101 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 131) | 107 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,345 (n = 133, n = 53) | 43 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 128) | 110 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,821 (n = 268, n = 123) | 106 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 1,989 (n = 119, n = 54) | 45 Participants |
| MTX + Placebo DB | Number of ACR 20 Responders in the DB and OL Periods | Day 2,185 (n = 85, n = 37) | 34 Participants |
Secondary
Number of ACR 50 Responders in the DB and OL Periods
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 729 (n = 338, n = 147) | 207 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 85 (n = 367, n = 158) | 128 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 813 (n = 321, n = 145) | 196 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 225 (n = 370, n = 159) | 188 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 897 (n = 314, n = 136) | 184 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 281 (n = 369, n = 159) | 193 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 981 (n = 302, n = 133) | 182 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 113 (n = 368, n = 159) | 142 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,093 (n = 306, n = 135) | 194 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 365 (n = 372, n = 160) | 202 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,177 (n = 266, n = 118) | 158 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 57 (n = 373, n = 159) | 82 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 130) | 176 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 449 (n = 366, n = 155) | 214 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,345 (n = 141, n = 56) | 83 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 141 (n = 371, n = 159) | 157 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 127) | 193 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 533 (n = 348, n = 156) | 213 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,625 (n = 274, n= 126) | 181 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 29 (n = 368, n=158) | 35 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,821 (n = 270, n = 123) | 165 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 617 (n = 346, n = 155) | 213 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,989 (n = 121, n = 55) | 78 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 169 (n = 373, n = 159) | 163 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 2,185 (n = 83, n = 37) | 46 Participants |
| ABA + MTX DB | Number of ACR 50 Responders in the DB and OL Periods | Day 15 (n = 371, n = 160) | 12 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 2,185 (n = 83, n = 37) | 22 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 15 (n = 371, n = 160) | 2 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 29 (n = 368, n=158) | 8 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 57 (n = 373, n = 159) | 15 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 85 (n = 367, n = 158) | 16 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 113 (n = 368, n = 159) | 25 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 141 (n = 371, n = 159) | 38 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 169 (n = 373, n = 159) | 35 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 225 (n = 370, n = 159) | 42 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 281 (n = 369, n = 159) | 38 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 365 (n = 372, n = 160) | 40 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 449 (n = 366, n = 155) | 70 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 533 (n = 348, n = 156) | 82 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 617 (n = 346, n = 155) | 87 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 729 (n = 338, n = 147) | 93 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 813 (n = 321, n = 145) | 85 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 897 (n = 314, n = 136) | 78 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 981 (n = 302, n = 133) | 79 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,093 (n = 306, n = 135) | 77 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,177 (n = 266, n = 118) | 64 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 130) | 76 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,345 (n = 141, n = 56) | 31 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 127) | 75 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,625 (n = 274, n= 126) | 84 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,821 (n = 270, n = 123) | 75 Participants |
| MTX + Placebo DB | Number of ACR 50 Responders in the DB and OL Periods | Day 1,989 (n = 121, n = 55) | 33 Participants |
Secondary
Number of ACR 70 Responders in the DB and OL Periods
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 29 (n = 369, n=159) | 8 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 533 (n = 350, n = 156) | 126 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 617 (n = 347, n = 154) | 116 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,093 (n = 309, n = 137) | 116 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,177 (n = 265, n = 122) | 94 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,625 (n = 278, n= 125) | 115 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 2,185 (n = 83, n = 37) | 32 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 15 (n = 371, n = 160) | 4 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 57 (n = 374, n = 159) | 27 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 85 (n = 370, n = 158) | 51 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 113 (n = 371, n = 159) | 56 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 141 (n = 371, n = 159) | 73 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 169 (n = 374, n = 159) | 83 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 225 (n = 369, n = 160) | 100 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 281 (n = 372, n = 160) | 104 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 365 (n = 374, n = 160) | 121 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 449 (n = 367, n = 157) | 122 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 729 (n = 340, n = 147) | 130 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 813 (n = 325, n = 146) | 117 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 897 (n = 314, n = 138) | 109 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 981 (n = 306, n = 134) | 116 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 132) | 105 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,345 (n = 139, n = 57) | 52 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 128) | 121 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,821 (n = 270, n = 125) | 107 Participants |
| ABA + MTX DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,989 (n = 119, n = 54) | 50 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,093 (n = 309, n = 137) | 44 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 281 (n = 372, n = 160) | 20 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 533 (n = 350, n = 156) | 47 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,177 (n = 265, n = 122) | 40 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 897 (n = 314, n = 138) | 40 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 365 (n = 374, n = 160) | 14 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,457 (n = 288, n = 128) | 47 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,625 (n = 278, n= 125) | 50 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 449 (n = 367, n = 157) | 33 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 617 (n = 347, n = 154) | 51 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 2,185 (n = 83, n = 37) | 14 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 15 (n = 371, n = 160) | 1 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,261 (n = 289, n = 132) | 45 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 29 (n = 369, n=159) | 2 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 729 (n = 340, n = 147) | 49 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 57 (n = 374, n = 159) | 6 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,989 (n = 119, n = 54) | 22 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 85 (n = 370, n = 158) | 7 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 813 (n = 325, n = 146) | 42 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 113 (n = 371, n = 159) | 10 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,345 (n = 139, n = 57) | 18 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 141 (n = 371, n = 159) | 12 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 1,821 (n = 270, n = 125) | 46 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 169 (n = 374, n = 159) | 14 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 981 (n = 306, n = 134) | 39 Participants |
| MTX + Placebo DB | Number of ACR 70 Responders in the DB and OL Periods | Day 225 (n = 369, n = 160) | 16 Participants |
Secondary
Number of New Tender Joints and Number of New Swollen Joints in the DB Period
Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.
Time frame: Day 169, Day 365
Population: These data were not summarized as it was determined that no meaningful information would be obtained.
Secondary
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 141 (n = 370, n = 159) | 238 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 2,185 (n = 85, n = 38) | 63 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 15 (n = 367, n = 160) | 115 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 29 (n = 365, n = 159) | 148 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 57 (n = 372, n = 157) | 199 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 85 (n = 366, n = 156) | 228 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 113 (n = 369, n = 159) | 239 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 169 (n = 373, n = 159) | 247 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 225 (n = 368, n = 159) | 252 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 281 (n = 368, n = 160) | 249 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 365 (n = 369, n = 160) | 265 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 449 (n = 366, n = 157) | 268 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 533 (n = 354, n = 157) | 259 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 617 (n = 348, n = 154) | 257 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 729 (n = 337, n = 148) | 248 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 813 (n = 325, n= 146) | 237 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 897 (n = 318, n = 140) | 232 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 981 (n = 312, n = 137) | 227 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,093 (n = 308, n = 137) | 225 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,177 (n = 274, n = 124) | 205 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,261 (n = 292, n = 134) | 214 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,345 (n = 152, n = 62) | 106 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,457 (n = 289, n = 129) | 218 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,625 (n =280, n = 126) | 210 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,821 (n = 271, n = 125) | 201 Participants |
| ABA + MTX DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,989 (n = 119, n = 55) | 90 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,177 (n = 274, n = 124) | 85 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 617 (n = 348, n = 154) | 107 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,821 (n = 271, n = 125) | 90 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 15 (n = 367, n = 160) | 46 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 729 (n = 337, n = 148) | 100 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 29 (n = 365, n = 159) | 57 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,261 (n = 292, n = 134) | 88 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 57 (n = 372, n = 157) | 73 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 813 (n = 325, n= 146) | 98 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 85 (n = 366, n = 156) | 76 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,625 (n =280, n = 126) | 92 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 113 (n = 369, n = 159) | 85 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,989 (n = 119, n = 55) | 35 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 141 (n = 370, n = 159) | 85 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 897 (n = 318, n = 140) | 99 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 169 (n = 373, n = 159) | 89 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,345 (n = 152, n = 62) | 40 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 225 (n = 368, n = 159) | 87 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 981 (n = 312, n = 137) | 91 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 281 (n = 368, n = 160) | 89 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 2,185 (n = 85, n = 38) | 26 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 365 (n = 369, n = 160) | 86 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,093 (n = 308, n = 137) | 94 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 449 (n = 366, n = 157) | 114 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 1,457 (n = 289, n = 129) | 94 Participants |
| MTX + Placebo DB | Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period | Day 533 (n = 354, n = 157) | 109 Participants |
Secondary
Number of Participants Achieving Major Clinical Response By Day 365
A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.
Time frame: Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Number of Participants Achieving Major Clinical Response By Day 365 | 60 Participants |
| MTX + Placebo DB | Number of Participants Achieving Major Clinical Response By Day 365 | 4 Participants |
p-value: <0.00195% CI: [7.3, 17.2]Chi-squared, Corrected
Secondary
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\> 5.1); low (≤ 3.2); remission (\< 2.6).
Time frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185
Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 15 (n = 355, n = 152) | 1 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 29 (n = 362, n =157) | 8 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 29 (n=362, 157) | 24 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 57 (n = 367, n = 156) | 19 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 57 (n=367, 156) | 44 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 85 (n = 366, n = 152) | 39 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 85 (n=366, 152) | 76 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 113 (n = 367, n = 159) | 39 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 113 (n=367, 159) | 89 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 141 (n = 366, n = 158) | 57 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 141 (n=366, 158) | 104 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 169 (n = 371, n = 159) | 63 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 169 (n=371, 159) | 117 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 225 (n = 366, n = 158) | 75 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 225 (n=366, 158) | 147 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 281 (n = 364, n = 159) | 89 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 281 (n=364, 159) | 150 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 365 (n = 370, n = 159) | 94 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 365 (n=370, 159) | 163 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 449 (n = 357, n = 150) | 100 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 449 (n=357, 150) | 162 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 533 (n = 343, n = 150) | 101 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,177 (n = 158, n = 71) | 55 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 15 (n=355, 152) | 5 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 553 (n=343, 150) | 158 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 617 (n = 334, n = 153) | 100 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 617 (n=334, 153) | 159 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 729 (n = 337, n = 148) | 97 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 729 (n=337, 148) | 175 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 813 (n = 317, n = 143) | 97 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 813 (n=317, 143) | 160 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 897 (n = 303, n = 135) | 91 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 897 (n=303, 135) | 152 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 981 (n = 297, n = 133) | 102 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 981 (n=297, 133) | 168 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,093 (n = 300, n = 129) | 112 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,093 (n=300, 129) | 160 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,177 (n=158, 71) | 84 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,261 (n = 267, n = 119) | 91 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,261 (n=267, 119) | 146 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,457 (n = 284, n = 129) | 111 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,457 (n=284, 129) | 161 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,625 (n = 272, n= 124) | 96 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,625 (n=272, 124) | 145 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,821 (n = 270, n = 124) | 89 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,821 (n=270, 124) | 147 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,989 (n=118, 54) | 43 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,989 (n=118, 54) | 65 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 2,185 (n=82, 37) | 25 Participants |
| ABA + MTX DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 2,185 (n=82, 37) | 41 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,177 (n=158, 71) | 42 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 15 (n=355, 152) | 1 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 617 (n = 334, n = 153) | 46 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 29 (n = 362, n =157) | 0 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 2,185 (n=82, 37) | 18 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 29 (n=362, 157) | 2 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 617 (n=334, 153) | 74 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 57 (n = 367, n = 156) | 1 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,261 (n = 267, n = 119) | 50 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 57 (n=367, 156) | 7 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 729 (n = 337, n = 148) | 45 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 85 (n = 366, n = 152) | 3 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,821 (n = 270, n = 124) | 47 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 729 (n=337, 148) | 77 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 113 (n = 367, n = 159) | 9 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,261 (n=267, 119) | 70 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 113 (n=367, 159) | 20 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 813 (n = 317, n = 143) | 46 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 141 (n = 366, n = 158) | 7 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,989 (n=118, 54) | 31 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 141 (n=366, 158) | 20 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 813 (n=317, 143) | 72 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 169 (n = 371, n = 159) | 6 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,457 (n = 284, n = 129) | 51 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 169 (n=371, 159) | 19 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 897 (n = 303, n = 135) | 48 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 225 (n = 366, n = 158) | 9 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,821 (n=270, 124) | 73 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 225 (n=366, 158) | 21 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 897 (n=303, 135) | 70 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 281 (n = 364, n = 159) | 14 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,457 (n=284, 129) | 79 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 281 (n=364, 159) | 33 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 981 (n = 297, n = 133) | 46 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 365 (n = 370, n = 159) | 4 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 2,185 (n=82, 37) | 22 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 365 (n=370, 159) | 19 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,625 (n = 272, n= 124) | 47 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 449 (n = 357, n = 150) | 32 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,093 (n = 300, n = 129) | 42 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 449 (n=357, 150) | 55 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,989 (n=118, 54) | 21 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 533 (n = 343, n = 150) | 42 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 981 (n=297, 133) | 72 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,093 (n=300, 129) | 77 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 15 (n = 355, n = 152) | 0 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Remission Day 1,177 (n = 158, n = 71) | 27 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 85 (n=366, 152) | 16 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 1,625 (n=272, 124) | 71 Participants |
| MTX + Placebo DB | Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time | Low Disease Activity Day 553 (n=343, 150) | 61 Participants |
Secondary
Number of Participants Discontinuing in the DB Period
Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.
Time frame: Day 1 to Day 169, Day 170 to Day 365
Population: All randomized and treated participants in the DB period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Discontinuing in the DB Period | Day 170 to Day 365 DC - All Causes | 16 Participants |
| ABA + MTX DB | Number of Participants Discontinuing in the DB Period | Day 1 to 169 Discontinuations (DC) - All Causes | 32 Participants |
| ABA + MTX DB | Number of Participants Discontinuing in the DB Period | Day 1 to 169 DC Due to Lack of Efficacy | 11 Participants |
| ABA + MTX DB | Number of Participants Discontinuing in the DB Period | Day 170 to Day 365 DC Due to Lack of Efficacy | 2 Participants |
| MTX + Placebo DB | Number of Participants Discontinuing in the DB Period | Day 170 to Day 365 DC Due to Lack of Efficacy | 7 Participants |
| MTX + Placebo DB | Number of Participants Discontinuing in the DB Period | Day 170 to Day 365 DC - All Causes | 12 Participants |
| MTX + Placebo DB | Number of Participants Discontinuing in the DB Period | Day 1 to 169 DC Due to Lack of Efficacy | 33 Participants |
| MTX + Placebo DB | Number of Participants Discontinuing in the DB Period | Day 1 to 169 Discontinuations (DC) - All Causes | 45 Participants |
Secondary
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
Time frame: Day 169, Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Tender Joints Day 169 | 43 Participants |
| ABA + MTX DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Tender Joints Day 365 | 67 Participants |
| ABA + MTX DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Swollen Joints Day 169 | 59 Participants |
| ABA + MTX DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Swollen Joints Day 365 | 78 Participants |
| MTX + Placebo DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Swollen Joints Day 365 | 9 Participants |
| MTX + Placebo DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Tender Joints Day 365 | 8 Participants |
| MTX + Placebo DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Tender Joints Day 169 | 9 Participants |
| MTX + Placebo DB | Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period | 100% Reduction in New Swollen Joints Day 169 | 14 Participants |
Secondary
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Time frame: Day 1 to Day 365
Population: All treated subjects in the DB period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Related SAEs | 15 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | AEs | 378 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | SAEs | 65 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Related AEs | 214 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Discontinuations Due to SAEs | 10 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Discontinued Due to AEs | 18 Participants |
| ABA + MTX DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Deaths | 1 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Discontinued Due to AEs | 4 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Deaths | 1 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | SAEs | 26 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Related SAEs | 1 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Discontinuations Due to SAEs | 3 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | AEs | 184 Participants |
| MTX + Placebo DB | Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period | Related AEs | 104 Participants |
Secondary
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Marked abnormality criteria were: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Time frame: Day 1 to Day 365
Population: All treated participants in the DB period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Leukocytes (LLN 4.0 x 10^3 c/uL) | 15 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Hemoglobin (LLN 11.5 g/dL) | 7 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Hematocrit (LLN 34%) | 4 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Platelet Count (LLN 140 x 10^3 c/uL) | 4 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | High Platelet Count (ULN 415 x 10^3 c/uL) | 1 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | High Leukocytes (ULN 10.5 x 10^3 c/uL) | 45 Participants |
| ABA + MTX DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Absolute Neutrophils (LLN 1.8 x 10^3 c/uL) | 10 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | High Leukocytes (ULN 10.5 x 10^3 c/uL) | 33 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | High Platelet Count (ULN 415 x 10^3 c/uL) | 0 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Hemoglobin (LLN 11.5 g/dL) | 4 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Leukocytes (LLN 4.0 x 10^3 c/uL) | 4 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Hematocrit (LLN 34%) | 3 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Absolute Neutrophils (LLN 1.8 x 10^3 c/uL) | 3 Participants |
| MTX + Placebo DB | Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period | Low Platelet Count (LLN 140 x 10^3 c/uL) | 1 Participants |
Secondary
Number of Participants With Immunogenicity to Abatacept in the DB Period
Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.
Time frame: Day 1 to Day 365
Population: Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Number of Participants With Immunogenicity to Abatacept in the DB Period | 6 Participants |
Secondary
Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
Marked abnormality criteria were: Aspartate Aminotransferase (AST) \>3 \* ULN or if BL \> ULN then use \>4 \*BL; Alanine Aminotransferase (ALT) \>3 \* ULN or if BL \> ULN then use \> 4 \* BL; Creatinine \> 1.5 \* BL.
Time frame: Day 1 to Day 365
Population: All treated participants in the DB period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High AST (ULN 40 U/L) | 4 Participants |
| ABA + MTX DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High ALT (ULN 55 U/L) | 7 Participants |
| ABA + MTX DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High Creatinine (ULN 1.5 mg/ dL) | 23 Participants |
| MTX + Placebo DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High Creatinine (ULN 1.5 mg/ dL) | 15 Participants |
| MTX + Placebo DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High AST (ULN 40 U/L) | 2 Participants |
| MTX + Placebo DB | Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period | High ALT (ULN 55 U/L) | 5 Participants |
Secondary
Participant RF Seroconversion in the OL Period
This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
Time frame: Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185
Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 729 (n=330, 143) | 8 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 365 (n=347, 146) | 2 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 365 (n=347, 146) | 31 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 729 (n=330, 143) | 31 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,093 (n=280, 119) | 6 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,093 (n=280, 119) | 27 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,457 (n=275, 118) | 5 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,457 (n=275, 118) | 27 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,821 (n=255, 115) | 4 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,821 (n=255, 115) | 25 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 2,185 (n=75, 31) | 3 Participants |
| ABA + MTX DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 2,185 (n=75, 31) | 7 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 2,185 (n=75, 31) | 3 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 729 (n=330, 143) | 1 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,457 (n=275, 118) | 4 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 365 (n=347, 146) | 3 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,821 (n=255, 115) | 9 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 365 (n=347, 146) | 2 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,457 (n=275, 118) | 8 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 729 (n=330, 143) | 10 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 2,185 (n=75, 31) | 2 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,093 (n=280, 119) | 3 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Positive Seroconversion Day 1,821 (n=255, 115) | 5 Participants |
| MTX + Placebo DB | Participant RF Seroconversion in the OL Period | Negative Seroconversion Day 1,093 (n=280, 119) | 7 Participants |
Secondary
Participants Experiencing AEs of Special Interest in the DB Period
AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
Time frame: Day 1 to Day 365
Population: All treated participants in the DB period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABA + MTX DB | Participants Experiencing AEs of Special Interest in the DB Period | Infections/Infestations | 50 Participants |
| ABA + MTX DB | Participants Experiencing AEs of Special Interest in the DB Period | Neoplasms | 14 Participants |
| ABA + MTX DB | Participants Experiencing AEs of Special Interest in the DB Period | Autoimmune Disorders | 13 Participants |
| ABA + MTX DB | Participants Experiencing AEs of Special Interest in the DB Period | Acute Infusional AEs | 38 Participants |
| MTX + Placebo DB | Participants Experiencing AEs of Special Interest in the DB Period | Acute Infusional AEs | 9 Participants |
| MTX + Placebo DB | Participants Experiencing AEs of Special Interest in the DB Period | Infections/Infestations | 12 Participants |
| MTX + Placebo DB | Participants Experiencing AEs of Special Interest in the DB Period | Autoimmune Disorders | 2 Participants |
| MTX + Placebo DB | Participants Experiencing AEs of Special Interest in the DB Period | Neoplasms | 9 Participants |
Secondary
Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period
All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.
Time frame: Day 1 to Day 365
Population: All randomized and treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period | 0 Participants |
| MTX + Placebo DB | Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period | 0 Participants |
Secondary
Participants in the DB Period Achieving an Extended Major Clinical Response
An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Time frame: Day 1 to Day 365
Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABA + MTX DB | Participants in the DB Period Achieving an Extended Major Clinical Response | 26 Participants |
| MTX + Placebo DB | Participants in the DB Period Achieving an Extended Major Clinical Response | 1 Participants |
p-value: 0.00295% CI: [2.4, 9]Chi-squared, Corrected