Rheumatoid Arthritis
Conditions
Brief summary
This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.
Detailed description
All participants who completed the 12-month double-blind study period were eligible to continue in the open-label study. Participants received placebo, Abatacept 2 mg/kg, or Abatacept 10 mg/kg in the double-blind study. Participants receiving placebo in the double-blind study were switched 1:1 to continued treatment with placebo or Abatacept 2 mg/kg. Participants receiving Abatacept 2 mg/kg or Abatacept 10 mg/kg continued at the double-blind study dosage. After results from the double-blind period became available, all participants were switched to a weight-tiered 10 mg/kg dose of Abatacept. Open label study design: Single group assignment, Single arm, Open label,
Interventions
IV, 10 mg/Kg, monthly, for the duration of the trial
DRUGPlacebo
Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Double blind study phase: 1. Males or females (not nursing and not pregnant), at least 18 years of age. Women of child bearing potential (WOCBP) are eligible if they are practicing effective contraceptive measures 2. Subjects must meet the criteria of the American Rheumatism Association (1987) for the diagnosis of rheumatoid arthritis and the American College of Rheumatology (1991) functional classes I, II, or III 3. Subjects have been taking Methotrexate (10-30 mg weekly) for at least 6 months, and at a stable dose for 28 days prior to treatment 4. Washout/drug stabilization requirements (except Methotrexate) \[Informed consent must be signed before making any changes in RA therapy if those changes are solely for the purpose of this study\]. * Leflunomide or Infliximab have already been discontinued at least 60 days prior to enrollment (prior to signing of informed consent) and a total of 90 days prior to treatment. All other Disease Modifying Anti-Rheumatic Drugs (DMARDs) (except Methotrexate) have been withdrawn at least 28 days prior to treatment * Oral corticosteroid treatment has been reduced to the equivalent of 10 mg or less prednisone daily and stabilized for at least 28 days prior to enrollment 5. Eligibility of subjects for the study is based on their disease activity and anti-rheumatic treatment at the initial visit: * Methotrexate monotherapy: Subject is receiving only Methotrexate, steroids, Non-steroidal anti-inflammatory drugs (NSAIDs) and will not require washout * Combination therapy: Subject is receiving Methotrexate in combination with another DMARD(s) and will require washout At entry, Methotrexate monotherapy must have a disease activity: * 10 or more swollen joints (66 joint count) * 12 or more tender joints (68 joint count) * C reactive protein (CRP) ≥.1 mg/dL (10 mg/L) at Screening visit At entry, combination therapy must have a disease activity (if subject does not satisfy the above): * 6 or more swollen joints (66 joint count) * 8 or more tender joints (68 joint count) * No restriction on C-reactive protein (CRP) In addition All subjects who were on combination therapy at entry must undergo a 28 day washout period of DMARDs other than Methotrexate. After the washout/drug stabilization and prior to randomization such subjects must have: * 10 or more swollen joints (66 joint count) * 12 or more tender joints (68 joint count) * C reactive protein (CRP) ≥ 1 mg/dL (10 mg/L) 6. Subject is willing to participate in the study and willing to sign the informed consent Open label study phase: * Participants that have completed the initial short term portion (double blind) of the study
Exclusion criteria
Double blind study phase: 1. Subjects who have at any time received treatment with BMS-188667 (Abatacept) 2. Subjects who within 30 days of the Day 1 visit have received treatment with any investigational drug 3. Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules) 4. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. Concomitant medical conditions that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study 5. Mammogram requiring further investigation or biopsies leading to the diagnosis of a clinically significant abnormality. Complete evaluation of lesion is required before initiation of dosing 6. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection) 7. Subjects who have a history of clinically significant drug or alcohol abuse, or admit to consumption of more than 1 alcoholic drink per day 8. Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection, or hepatitis B or C infection 9. Subjects with any serious or chronic infections such as pneumonia, pyelo-nephritis, renal infection, chest infection with bronchiectasis, or sinusitis in the previous 3 months 10. Subjects with active tuberculosis requiring treatment within the previous 3 years 11. Subjects with any opportunistic infections such as herpes zoster or cytomegalovirus (CMV) within the previous 2 months 12. Subjects with severe asthma defined as \> 3 emergency room admissions in the last year or \> 3 treatments with oral steroids for asthma in the last year 13. A history of either angioedema or anaphylaxis that was associated with a reaction to a drug 14. Subjects with the following laboratory values: * Hemoglobin \< 8.5 g/dL * White blood cells \< 3000/mm3 * Platelets \< 100,000/mm3 * Serum creatinine \> 2 times upper limit of normal * Serum Alanine aminotransferase (ALAT) or Aspartate aminotransferase (ASAT) \> 2 times upper limit of normal * Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study Open label study phase: * Participants must continue to meet inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period | Day 180 | ACR 20 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. |
| Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Day 360 to Day 3,060 | The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics. |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Day 360 to Day 3060 | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug. |
| Number of Participants With AEs of Special Interest in OL Period | Day 360 to Day 3060 | 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 were 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. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion. |
| Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800 | Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6. |
| Mean Change From Baseline (BL) in IgA Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5. |
| Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800 | Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8. |
| Mean Change From Baseline (BL) in IgG Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7. |
| Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline (Day 0) and Days 360, 720,1080,1440, and 1800 | Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10. |
| Mean Change From Baseline (BL) in IgM in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9. |
| Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Day 360 to Day 3060 | — |
| Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | Day 360 to Day 3060 | — |
| Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Day 360 to Day 3060 | — |
| Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | Day 360 to Day 3060 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period) | — |
| Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline, Days 30, 90, 180, 270, 360 | — |
| Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Baseline, Days 30, 90, 180, 270, 360 | Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion. |
| Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Baseline, Days 30, 90, 180, 270, 360 | Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion. |
| Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Baseline, Day 180, Day 360 | — |
| Number of ACR 20 Responders in OL Period | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | ACR 20 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits. |
| Number of ACR 50 Responders in the OL Period | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | ACR 50 response requires a participant 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, participant global assessment of disease, participant 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. |
| Number of ACR 70 Responders in the OL Period | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, 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 With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units. |
| Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. |
| Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point. |
| Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. |
| Mean Change From Baseline in sIL2-r Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. |
| Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060 | Serum evaluations were carried out to evaluate participant serum CRP concentrations at 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 Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060 | Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. |
| Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50. |
| Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49. |
| Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL. |
| Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51. |
| Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54. |
| Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53. |
| Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56. |
| Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55. |
| Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline, Days 30, 90, 180, 270, 360 | — |
| Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57. |
| Mean BL General Health Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60. |
| Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59. |
| Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62. |
| Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61. |
| Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64. |
| Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63. |
| Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66. |
| Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65. |
| Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68. |
| Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67. |
| Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58. |
| Number of ACR 20 Responders in DB Period | Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360 | ACR 20 response requires a participant 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, participant global assessment of disease, participant 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. |
| Number of ACR 50 Responders in DB Period | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | ACR 50 response requires a participant 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, participant global assessment of disease, participant 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. |
| Number of ACR 70 Responders in DB Period | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | ACR 70 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, 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. |
| ACR Numeric Values (ACR-N) | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. |
| ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Baseline and Day 180; Baseline and Day 360 | The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N. |
| Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Baseline, Day 180 | Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\]) |
| Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Baseline, Day 360 | Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\]) |
| Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | Baseline, Day 180, Day 360 | SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. |
| Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Baseline, Day 180, Day 360 | A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100. |
| Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | Day 180, Day 360 | — |
| Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | From the start of study through the end of the double-blind period (at 12 months) | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug. |
| Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | From the start of study up to 60 days post the end of the 12-month double-blind period | — |
| Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | From the start of study up to 60 days post the end of the 12-month double-blind period | — |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Ireland, Netherlands, South Africa, United Kingdom, United States
Participant flow
Pre-assignment details
Of 524 subjects who were enrolled in this study, 185 were not randomized (1 reason unknown; 2 adverse event; 9 withdrawal of consent; 160 failure to meet inclusion and/or exclusion criteria; 1 death; 12 for other reasons).
Participants by arm
| Arm | Count |
|---|---|
| Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | 115 |
| Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | 105 |
| Double-Blind (DB) Placebo + Methotrexate Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | 119 |
| Total | 339 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Period | Adverse Event | 5 | 9 | 11 | 0 |
| Double-Blind Period | Death | 0 | 1 | 0 | 0 |
| Double-Blind Period | Lack of Efficacy | 13 | 17 | 30 | 0 |
| Double-Blind Period | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Double-Blind Period | Other Reason | 1 | 0 | 1 | 0 |
| Double-Blind Period | Withdrawal by Subject | 5 | 2 | 6 | 0 |
| Open-Label Period | Administrative Reason By Sponsor | 0 | 0 | 0 | 9 |
| Open-Label Period | Adverse Event | 0 | 0 | 0 | 46 |
| Open-Label Period | Death | 0 | 0 | 0 | 7 |
| Open-Label Period | Lack of Efficacy | 0 | 0 | 0 | 26 |
| Open-Label Period | Lost to Follow-up | 0 | 0 | 0 | 3 |
| Open-Label Period | Other Reasons | 0 | 0 | 0 | 15 |
| Open-Label Period | Withdrawal by Subject | 0 | 0 | 0 | 31 |
Baseline characteristics
| Characteristic | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Total | Double-Blind (DB) Placebo + Methotrexate | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate |
|---|---|---|---|---|
| Age Continuous | 55.8 years STANDARD_DEVIATION 12.5 | 55.0 years STANDARD_DEVIATION 11.9 | 54.7 years STANDARD_DEVIATION 12 | 54.4 years STANDARD_DEVIATION 11.3 |
| C-Reactive Protein (CRP) Serum Level | 2.9 mg/dL STANDARD_DEVIATION 2.8 | 3.1 mg/dL STANDARD_DEVIATION 2.9 | 3.2 mg/dL STANDARD_DEVIATION 3.2 | 3.2 mg/dL STANDARD_DEVIATION 2.5 |
| Duration of Participant Rheumatoid Arthritis (RA) | 9.7 Years STANDARD_DEVIATION 9.8 | 9.4 Years STANDARD_DEVIATION 8.8 | 8.9 Years STANDARD_DEVIATION 8.3 | 9.7 Years STANDARD_DEVIATION 8.1 |
| Number of Swollen Joints | 21.3 Joints STANDARD_DEVIATION 8.4 | 21.1 Joints STANDARD_DEVIATION 8.7 | 21.8 Joints STANDARD_DEVIATION 8.8 | 20.2 Joints STANDARD_DEVIATION 8.9 |
| Number of Tender Joints | 30.8 Joints STANDARD_DEVIATION 12.2 | 29.4 Joints STANDARD_DEVIATION 12.4 | 29.2 Joints STANDARD_DEVIATION 13 | 28.2 Joints STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Black | 6 Participants | 9 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 35 Participants | 12 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 100 Participants | 295 Participants | 104 Participants | 91 Participants |
| Rheumatoid Factor Status Negative | 14 Participants | 56 Participants | 27 Participants | 15 Participants |
| Rheumatoid Factor Status Positive | 99 Participants | 279 Participants | 90 Participants | 90 Participants |
| Sex: Female, Male Female | 86 Participants | 231 Participants | 79 Participants | 66 Participants |
| Sex: Female, Male Male | 29 Participants | 108 Participants | 40 Participants | 39 Participants |
| Weight | 77.8 Kg STANDARD_DEVIATION 18.6 | 78.8 Kg STANDARD_DEVIATION 19.2 | 79.9 Kg STANDARD_DEVIATION 17.6 | 78.7 Kg STANDARD_DEVIATION 21.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 96 / 115 | 98 / 105 | 200 / 219 | 108 / 119 |
| serious Total, serious adverse events | 17 / 115 | 19 / 105 | 117 / 219 | 21 / 119 |
Outcome results
Primary
Baseline Immunoglobulin G (IgG) Over Time in OL Period
Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 38, 34) | 1152.63 mg/dL | Standard Deviation 305.01 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 360 cohort (n=75, 59, 60) | 1130.31 mg/dL | Standard Deviation 295.28 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1080 cohort (n=60, 45, 45) | 1145.15 mg/dL | Standard Deviation 305.51 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 720 cohort (n=72, 53, 53) | 1138.58 mg/dL | Standard Deviation 303.24 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1440 cohort (n=55, 37, 37) | 1154.58 mg/dL | Standard Deviation 315 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 720 cohort (n=72, 53, 53) | 1093.23 mg/dL | Standard Deviation 318.24 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 38, 34) | 1092.76 mg/dL | Standard Deviation 260.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1440 cohort (n=55, 37, 37) | 1095.49 mg/dL | Standard Deviation 261.86 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 360 cohort (n=75, 59, 60) | 1086.05 mg/dL | Standard Deviation 263.41 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1080 cohort (n=60, 45, 45) | 1053.91 mg/dL | Standard Deviation 264.53 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 38, 34) | 1137.21 mg/dL | Standard Deviation 368.39 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 360 cohort (n=75, 59, 60) | 1079.00 mg/dL | Standard Deviation 345.72 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 720 cohort (n=72, 53, 53) | 1076.40 mg/dL | Standard Deviation 333.08 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1440 cohort (n=55, 37, 37) | 1135.43 mg/dL | Standard Deviation 381.72 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin G (IgG) Over Time in OL Period | Baseline for Day 1080 cohort (n=60, 45, 45) | 1136.27 mg/dL | Standard Deviation 372.58 |
Primary
Baseline Immunoglobulin M (IgM) Over Time in OL Period
Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.
Time frame: Baseline (Day 0) and Days 360, 720,1080,1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 141.69 mg/dL | Standard Deviation 77.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 144.75 mg/dL | Standard Deviation 78.89 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 147.76 mg/dL | Standard Deviation 76.05 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 147.76 mg/dL | Standard Deviation 76.31 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1800 cohort (n=45, 33, 32) | 133.22 mg/dL | Standard Deviation 61.79 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 127.36 mg/dL | Standard Deviation 68.06 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 134.29 mg/dL | Standard Deviation 66.81 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 137.79 mg/dL | Standard Deviation 69.93 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 136.22 mg/dL | Standard Deviation 70.9 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1800 cohort (n=45, 33, 32) | 124.15 mg/dL | Standard Deviation 67.07 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1800 cohort (n=45, 33, 32) | 124.63 mg/dL | Standard Deviation 58.69 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 133.51 mg/dL | Standard Deviation 58.04 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 125.10 mg/dL | Standard Deviation 52.12 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 129.04 mg/dL | Standard Deviation 54.79 |
| DB Placebo + Methotrexate | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 123.25 mg/dL | Standard Deviation 52.79 |
Primary
Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period
Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.
Time frame: Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 287.09 mg/dL | Standard Deviation 136.5 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 287.27 mg/dL | Standard Deviation 140.22 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 308.09 mg/dL | Standard Deviation 152.27 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 290.25 mg/dL | Standard Deviation 146.27 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1800 cohort (n=50, 38, 34) | 292.78 mg/dL | Standard Deviation 146.91 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 321.02 mg/dL | Standard Deviation 153.81 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 341.54 mg/dL | Standard Deviation 148.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 338.58 mg/dL | Standard Deviation 151.76 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 327.27 mg/dL | Standard Deviation 162.13 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1800 cohort (n=50, 38, 34) | 327.34 mg/dL | Standard Deviation 163.27 |
| DB Placebo + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1800 cohort (n=50, 38, 34) | 244.71 mg/dL | Standard Deviation 118.03 |
| DB Placebo + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1440 cohort (n=54, 37, 37) | 250.11 mg/dL | Standard Deviation 127.88 |
| DB Placebo + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 360 cohort (n=74, 59, 60) | 264.22 mg/dL | Standard Deviation 133.9 |
| DB Placebo + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 1080 cohort (n=59, 45, 45) | 266.89 mg/dL | Standard Deviation 143.48 |
| DB Placebo + Methotrexate | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Baseline for Day 720 cohort (n=71, 53, 53) | 256.64 mg/dL | Standard Deviation 132.78 |
Primary
Mean Change From Baseline (BL) in IgA Over Time in OL Period
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | -30.52 mg/dL | Standard Error 9.75 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | -33.10 mg/dL | Standard Error 13.08 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 360 (n=74, 59, 60) | -38.24 mg/dL | Standard Error 5.95 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 720 (n=71, 53, 53) | -28.20 mg/dL | Standard Error 8.61 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1800 (n=50, 38, 34) | -20.06 mg/dL | Standard Error 26.97 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | -52.87 mg/dL | Standard Error 12.86 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 360 (n=74, 59, 60) | -25.66 mg/dL | Standard Error 7.83 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 720 (n=71, 53, 53) | -45.06 mg/dL | Standard Error 9.27 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | -52.49 mg/dL | Standard Error 16.32 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1800 (n=50, 38, 34) | -65.95 mg/dL | Standard Error 16.26 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1800 (n=50, 38, 34) | -25.68 mg/dL | Standard Error 12.18 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | -4.41 mg/dL | Standard Error 12.28 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 360 (n=74, 59, 60) | 5.00 mg/dL | Standard Error 6.72 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | -15.87 mg/dL | Standard Error 11.18 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Change from BL at Day 720 (n=71, 53, 53) | -20.89 mg/dL | Standard Error 7.73 |
Primary
Mean Change From Baseline (BL) in IgG Over Time in OL Period
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1440 (n=55, 37, 37) | -228.11 mg/dL | Standard Error 28.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1080 (n=60, 45, 45) | -199.58 mg/dL | Standard Error 33.68 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 360 (n=75, 59, 60) | -181.92 mg/dL | Standard Error 19.78 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 720 (n=72, 53, 53) | -183.04 mg/dL | Standard Error 28.58 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1800 (n=51, 38, 34) | -217.43 mg/dL | Standard Error 39.52 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1080 (n=60, 45, 45) | -229.91 mg/dL | Standard Error 26.75 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 360 (n=75, 59, 60) | -110.71 mg/dL | Standard Error 21.46 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 720 (n=72, 53, 53) | -168.55 mg/dL | Standard Error 31.82 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1440 (n=55, 37, 37) | -279.14 mg/dL | Standard Error 33.43 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1800 (n=51, 38, 34) | -206.21 mg/dL | Standard Error 39.1 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1800 (n=51, 38, 34) | -187.94 mg/dL | Standard Error 44.4 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1440 (n=55, 37, 37) | -147.46 mg/dL | Standard Error 45.84 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 360 (n=75, 59, 60) | -15.12 mg/dL | Standard Error 21.71 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 1080 (n=60, 45, 45) | -150.40 mg/dL | Standard Error 33.97 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Change from BL at Day 720 (n=72, 53, 53) | -137.06 mg/dL | Standard Error 31.62 |
Primary
Mean Change From Baseline (BL) in IgM in OL Period
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | 2.52 mg/dL | Standard Error 7.07 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | 0.37 mg/dL | Standard Error 6.69 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 360 (n=74, 59, 60) | -5.81 mg/dL | Standard Error 3.49 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 720 (n=71, 53, 53) | 12.68 mg/dL | Standard Error 7.32 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1,800 (n=45, 33, 32) | 7.84 mg/dL | Standard Error 6.89 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | 1.93 mg/dL | Standard Error 6.61 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 360 (n=74, 59, 60) | 3.22 mg/dL | Standard Error 4.36 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 720 (n=71, 53, 53) | 0.11 mg/dL | Standard Error 4.76 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | 0.68 mg/dL | Standard Error 8.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1,800 (n=45, 33, 32) | 9.06 mg/dL | Standard Error 7.55 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1,800 (n=45, 33, 32) | 6.72 mg/dL | Standard Error 8.8 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1440 (n=54, 37, 37) | 14.46 mg/dL | Standard Error 9.52 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 360 (n=74, 59, 60) | 11.17 mg/dL | Standard Error 3.89 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 1080 (n=59, 45, 45) | 27.93 mg/dL | Standard Error 11.62 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in IgM in OL Period | Change from BL at Day 720 (n=71, 53, 53) | 6.45 mg/dL | Standard Error 6.11 |
Primary
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | AEs | 211 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Related AEs | 144 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Discontinued Due to AEs | 44 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | SAEs | 117 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Related SAEs | 37 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Discontinued Due to SAEs | 33 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | Deaths | 8 Participants |
Primary
Number of Participants With AEs of Special Interest in 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 were 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. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With AEs of Special Interest in OL Period | Peri-Infusional AEs | 47 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With AEs of Special Interest in OL Period | Infections/Infestations | 179 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With AEs of Special Interest in OL Period | Malignant Neoplasms | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With AEs of Special Interest in OL Period | Autoimmune Disorders | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With AEs of Special Interest in OL Period | Acute Infusional AEs | 20 Participants |
Primary
Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | High Serum Chloride (>106 mEq/L; n=217) | 3 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Low Serum Sodium (<135 mEq/L; n=217) | 4 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | High Serum Sodium (>145 mEq/L; n=217) | 10 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Low Serum Potassium (<3.5 mEq/L; n=217) | 8 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | High Serum Potassium (>5.0 mEq/L; n=217) | 10 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Low Serum Chloride (<97 mEq/L; n=217) | 8 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Low Total Calcium (<8.6 mg/dL; n=217) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | High Total Calcium (>10.2 mg/dL; n=217) | 3 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | Low Inorganic Phosphorus (<2.7 mg/dL; n=217) | 5 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | High Inorganic Phosphorus (> 4.5 mg/dL; n=217) | 11 Participants |
Primary
Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | Low Serum Glucose (< 70 mg/dL; n=217) | 33 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Serum Glucose (> 110 mg/dL; n=217) | 30 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | Low Fasting Serum Glucose (< 70 mg/dL; n=1) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Fasting Serum Glucose (> 110 mg/dL; n=1) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | Low Total Protein (< 6.2 grams/dL; n=217) | 12 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Total Protein (>8.3 grams/dL; n=217) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | Low Albumin (<3.5 grams/dL; n=217) | 7 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Uric Acid (>7.6 mg/dL; n=217) | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Urine Protein (> trace; n=217) | 29 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Urine Glucose (> trace; n=217) | 32 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Urine Blood (> trace; n=217) | 47 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Urine White Blood Cell Count (> trace; n=162) | 74 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | High Urine Red Blood Cell Count (> trace; n=162) | 51 Participants |
Primary
Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Hemoglobin (> 13.0 grams/dL; n=216) | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Hematocrit (< 35%; n=216) | 11 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Platelet Count (<145*10^9 cells/L; n=214) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Platelet Count (>400*10^9 cells/L; n=214) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Leukocytes (<3.60 *10^3 cells/µL; n=216) | 12 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Leukocytes (>10.30*10^3 cells/µL; n=216) | 49 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Neutrophils + Bands (<2.0*10^3 c/uL; n=217) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | Low Absolute Lymphocytes(<1.0*10^3cells/µL; n=217) | 48 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Absolute Lymphocytes(>3.5*10^3cells/µL;n=217) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Absolute Monocytes (>720*10^3cells/µL; n=217) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Absolute Basophils(>0.2*10^3 cells/µL; n=217) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | High Absolute Eosinophils(>0.4*10^3cells/µL;n=217) | 21 Participants |
Primary
Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period
Time frame: Day 360 to Day 3060
Population: All treated OL participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Alkaline Phosphatase (>117 IU/L) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Aspartate Aminotransferase (>38 IU/L) | 6 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Alanine Aminotransferase (>30 IU/L) | 5 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High G-Glutamyl Transferase (>61 IU/L) | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Total Bilirubin (>1.1 mg/dL) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Blood Urea Nitrogen (>21.3 mg/dL) | 14 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | High Creatinine (>1.30 mg/dL) | 13 Participants |
Primary
Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period
ACR 20 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire 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 180
Population: Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period | 70 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period | 44 Participants |
| DB Placebo + Methotrexate | Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period | 42 Participants |
p-value: <0.00195% CI: [12.8, 38.4]Chi-squared
p-value: 0.3195% CI: [-6.2, 19.4]Chi-squared
Primary
Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period
The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.
Time frame: Day 360 to Day 3,060
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Etanercept | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Leflunamide | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Cyclosporine | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Nonsteroidal antiinfllammatory drugs | 78 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Hydroxychloroquine | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Gold Sodium Thiomalate | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Methotrexate | 84 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Corticosteroids (oral and/or injectable) | 72 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Adalimumab | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Azanthioprine | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Infliximab | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Sulfasalazine | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Chloroquine | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Gold Sodium Thiomalate | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Methotrexate | 68 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Corticosteroids (oral and/or injectable) | 57 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Nonsteroidal antiinfllammatory drugs | 63 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Azanthioprine | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Chloroquine | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Cyclosporine | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Hydroxychloroquine | 3 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Leflunamide | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Sulfasalazine | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Adalimumab | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Etanercept | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Infliximab | 1 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Leflunamide | 1 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Azanthioprine | 1 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Etanercept | 0 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Sulfasalazine | 1 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Nonsteroidal antiinfllammatory drugs | 64 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Methotrexate | 67 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Adalimumab | 0 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Gold Sodium Thiomalate | 0 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Cyclosporine | 0 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Corticosteroids (oral and/or injectable) | 56 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Hydroxychloroquine | 2 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Chloroquine | 1 Participants |
| DB Placebo + Methotrexate | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | Infliximab | 0 Participants |
Secondary
ACR-N Area Under The Curve (AUC) on Day 180 and Day 360
The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.
Time frame: Baseline and Day 180; Baseline and Day 360
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 180 | 5021.70 percentage*days | Standard Error 317.9 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 360 | 12035.1 percentage*days | Standard Error 711.7 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 180 | 3242.54 percentage*days | Standard Error 332.7 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 360 | 7447.87 percentage*days | Standard Error 744.8 |
| DB Placebo + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 180 | 2889.07 percentage*days | Standard Error 312.5 |
| DB Placebo + Methotrexate | ACR-N Area Under The Curve (AUC) on Day 180 and Day 360 | Day 360 | 6393.49 percentage*days | Standard Error 699.6 |
Comparison: Comparison at Day 180p-value: 0.000195% CI: [1067.32, 3197.94]ANOVA
Comparison: Comparison at Day 180p-value: 0.439395% CI: [-544.46, 1251.41]ANOVA
Comparison: Comparison at Day 360p-value: 0.000195% CI: [2823.46, 8459.74]ANOVA
Comparison: Comparison at Day 360p-value: 0.302995% CI: [-955.59, 3064.35]ANOVA
Secondary
ACR Numeric Values (ACR-N)
The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.
Time frame: Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Population: Participants who received at least 1 infusion of study medication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 15 (n=113, 104, 118) | 11.09 units on a scale | Standard Deviation 15.53 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 30 (n=115, 104, 117) | 20.45 units on a scale | Standard Deviation 23.41 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 60 (n=114, 105, 119) | 28.85 units on a scale | Standard Deviation 26.78 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 90 (n=115, 105, 118) | 29.03 units on a scale | Standard Deviation 27.38 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 120 (n=114, 105, 115) | 33.80 units on a scale | Standard Deviation 29.35 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 150 (n=114, 103, 118) | 36.34 units on a scale | Standard Deviation 30.29 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 180 (n=114, 104, 118) | 37.65 units on a scale | Standard Deviation 30.39 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 240 (n=115, 104, 119) | 38.34 units on a scale | Standard Deviation 31.49 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 300 (n=114, 105, 119) | 39.69 units on a scale | Standard Deviation 31.08 |
| DB Abatacept 10 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 360 (n=115, 105, 119) | 40.87 units on a scale | Standard Deviation 31.69 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 300 (n=114, 105, 119) | 21.82 units on a scale | Standard Deviation 27.99 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 15 (n=113, 104, 118) | 5.26 units on a scale | Standard Deviation 10.37 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 150 (n=114, 103, 118) | 22.69 units on a scale | Standard Deviation 24.15 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 120 (n=114, 105, 115) | 22.87 units on a scale | Standard Deviation 26.1 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 30 (n=115, 104, 117) | 12.06 units on a scale | Standard Deviation 18.11 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 360 (n=115, 105, 119) | 24.55 units on a scale | Standard Deviation 29.37 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 240 (n=115, 104, 119) | 23.49 units on a scale | Standard Deviation 27.51 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 60 (n=114, 105, 119) | 17.69 units on a scale | Standard Deviation 22.83 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 180 (n=114, 104, 118) | 24.67 units on a scale | Standard Deviation 29.03 |
| DB Abatacept 2 mg/kg + Methotrexate | ACR Numeric Values (ACR-N) | Day 90 (n=115, 105, 118) | 21.12 units on a scale | Standard Deviation 26.1 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 240 (n=115, 104, 119) | 20.71 units on a scale | Standard Deviation 25.97 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 90 (n=115, 105, 118) | 16.93 units on a scale | Standard Deviation 21.61 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 120 (n=114, 105, 115) | 19.26 units on a scale | Standard Deviation 23.7 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 150 (n=114, 103, 118) | 19.37 units on a scale | Standard Deviation 24.74 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 300 (n=114, 105, 119) | 18.69 units on a scale | Standard Deviation 23.53 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 180 (n=114, 104, 118) | 17.29 units on a scale | Standard Deviation 22.02 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 15 (n=113, 104, 118) | 9.07 units on a scale | Standard Deviation 14.76 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 360 (n=115, 105, 119) | 20.49 units on a scale | Standard Deviation 26.14 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 30 (n=115, 104, 117) | 13.20 units on a scale | Standard Deviation 17.85 |
| DB Placebo + Methotrexate | ACR Numeric Values (ACR-N) | Day 60 (n=114, 105, 119) | 17.09 units on a scale | Standard Deviation 20.9 |
Comparison: Day 15 Treatment Comparisonp-value: 0.267695% CI: [-1.56, 5.61]ANOVA
Comparison: Day 15 Treatment Comparisonp-value: 0.041895% CI: [-7.46, -0.14]ANOVA
Comparison: Day 30 Treatment Comparisonp-value: 0.006195% CI: [2.08, 12.41]ANOVA
Comparison: Day 30 Treatment Comparisonp-value: 0.671395% CI: [-6.45, 4.16]ANOVA
Comparison: Day 60 Treatment Comparisonp-value: 0.000295% CI: [5.67, 17.84]ANOVA
Comparison: Day 60 Treatment Comparisonp-value: 0.849595% CI: [-5.62, 6.82]ANOVA
Comparison: Day 90 Treatment Comparisonp-value: 0.000395% CI: [5.63, 18.56]ANOVA
Comparison: Day 90 Treatment Comparisonp-value: 0.000395% CI: [-2.44, 10.81]ANOVA
Comparison: Day 120 Treatment Comparisonp-value: 0.000195% CI: [7.28, 21.81]ANOVA
Comparison: Day 120 Treatment Comparisonp-value: 0.314195% CI: [-3.43, 10.64]ANOVA
Comparison: Day 150 Treatment Comparisonp-value: 0.000195% CI: [8.49, 25.43]ANOVA
Comparison: Day 150 Treatment Comparisonp-value: 0.355295% CI: [-3.73, 10.37]ANOVA
Comparison: Day 180 Treatment Comparisonp-value: 0.000195% CI: [10.19, 30.54]ANOVA
Comparison: Day 180 Treatment Comparisonp-value: 0.045195% CI: [0.16, 14.6]ANOVA
Comparison: Day 240 Treatment Comparisonp-value: 0.000195% CI: [8.83, 26.44]ANOVA
Comparison: Day 240 Treatment Comparisonp-value: 0.466995% CI: [-4.73, 10.28]ANOVA
Comparison: Day 300 Treatment Comparisonp-value: 0.000195% CI: [10.51, 31.48]ANOVA
Comparison: Day 300 Treatment Comparisonp-value: 3.1395% CI: [-4.15, 10.41]ANOVA
Comparison: Day 360 Treatment Comparisonp-value: 0.000195% CI: [10.2, 30.56]ANOVA
Comparison: Day 360 Treatment Comparisonp-value: 0.298995% CI: [-3.61, 11.72]ANOVA
Secondary
Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360
A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean Percentage Change at Day 180 (n=107, 98, 110) | 41.39 Percentage of Change on mHAQ scale | Standard Error 5.43 |
| DB Abatacept 10 mg/kg + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean PercentageChange at Day 360 (n=109, 100, 111) | 42.49 Percentage of Change on mHAQ scale | Standard Error 5.05 |
| DB Abatacept 2 mg/kg + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean Percentage Change at Day 180 (n=107, 98, 110) | 21.41 Percentage of Change on mHAQ scale | Standard Error 5.67 |
| DB Abatacept 2 mg/kg + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean PercentageChange at Day 360 (n=109, 100, 111) | 22.74 Percentage of Change on mHAQ scale | Standard Error 5.27 |
| DB Placebo + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean Percentage Change at Day 180 (n=107, 98, 110) | 13.73 Percentage of Change on mHAQ scale | Standard Error 5.35 |
| DB Placebo + Methotrexate | Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360 | Mean PercentageChange at Day 360 (n=109, 100, 111) | 10.26 Percentage of Change on mHAQ scale | Standard Error 5 |
Comparison: Day 180p-value: 0.000395% CI: [12.67, 42.66]ANCOVA
Comparison: Day 180p-value: 0.3253ANCOVA
Comparison: Day 360p-value: 0.000195% CI: [16.14, 48.33]ANCOVA
Comparison: Day 360p-value: 0.086995% CI: [-1.82, 26.78]ANCOVA
Secondary
Baseline Level of Serum Rheumatoid Factor Over Time in OL Period
Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Time frame: Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1440 cohort (n=57, 41, 41) | 243.32 IU/mL | Standard Deviation 363.86 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 3060 (n=7, 9, 5) | 214.29 IU/mL | Standard Deviation 120 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2160 (n=43, 34, 30) | 185.74 IU/mL | Standard Deviation 173.26 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 41, 40) | 165.39 IU/mL | Standard Deviation 152.94 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 360 cohort (n=80, 62, 65) | 291.98 IU/mL | Standard Deviation 374.41 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2880 (n=15, 16, 13) | 159.93 IU/mL | Standard Deviation 123.69 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 49, 47) | 233.95 IU/mL | Standard Deviation 346.73 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 720 cohort (n=69, 57, 54) | 256.12 IU/mL | Standard Deviation 361.74 |
| DB Abatacept 10 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2520 (n=23, 24, 22) | 175.13 IU/mL | Standard Deviation 156.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 41, 40) | 175.41 IU/mL | Standard Deviation 206.37 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 360 cohort (n=80, 62, 65) | 219.24 IU/mL | Standard Deviation 262.55 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 720 cohort (n=69, 57, 54) | 217.21 IU/mL | Standard Deviation 267.03 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 49, 47) | 172.00 IU/mL | Standard Deviation 204.63 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1440 cohort (n=57, 41, 41) | 165.39 IU/mL | Standard Deviation 173.31 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2160 (n=43, 34, 30) | 181.91 IU/mL | Standard Deviation 216.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2520 (n=23, 24, 22) | 158.42 IU/mL | Standard Deviation 210.74 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2880 (n=15, 16, 13) | 197.63 IU/mL | Standard Deviation 251.82 |
| DB Abatacept 2 mg/kg + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 3060 (n=7, 9, 5) | 223.44 IU/mL | Standard Deviation 316.59 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 49, 47) | 203.94 IU/mL | Standard Deviation 250.44 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 360 cohort (n=80, 62, 65) | 233.57 IU/mL | Standard Deviation 299.75 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2520 (n=23, 24, 22) | 269.55 IU/mL | Standard Deviation 309.15 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 720 cohort (n=69, 57, 54) | 227.81 IU/mL | Standard Deviation 308.53 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 3060 (n=7, 9, 5) | 232.60 IU/mL | Standard Deviation 202.38 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1800 cohort (n=51, 41, 40) | 205.33 IU/mL | Standard Deviation 254.25 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 1440 cohort (n=57, 41, 41) | 215.71 IU/mL | Standard Deviation 258.6 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2880 (n=15, 16, 13) | 366.38 IU/mL | Standard Deviation 362.39 |
| DB Placebo + Methotrexate | Baseline Level of Serum Rheumatoid Factor Over Time in OL Period | Baseline for Day 2160 (n=43, 34, 30) | 194.17 IU/mL | Standard Deviation 254.3 |
Secondary
Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region
Time frame: Baseline, Days 30, 90, 180, 270, 360
Population: Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 30 Cohort (n=110, 100) | 9151.8 titers | Standard Deviation 10692.68 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 30 (n=110, 100) | 8361.5 titers | Standard Deviation 9931.79 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 90 Cohort (n=110, 99) | 9052.8 titers | Standard Deviation 10392.26 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 90 (n=110, 99) | 6842.3 titers | Standard Deviation 7659.01 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 180 Cohort (n=102, 90) | 8853.6 titers | Standard Deviation 10330.92 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 180 (n=102, 90) | 5967.3 titers | Standard Deviation 6535.57 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 270 Cohort (n=94, 73) | 13149.7 titers | Standard Deviation 14850.07 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 270 (n=94, 73) | 8027.5 titers | Standard Deviation 8863.47 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 360 Cohort (n=83, 74) | 13287.8 titers | Standard Deviation 15024.78 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 360 (n=83, 74) | 8675.1 titers | Standard Deviation 10038.76 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 270 (n=94, 73) | 9725.9 titers | Standard Deviation 11337.2 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 30 Cohort (n=110, 100) | 8861.8 titers | Standard Deviation 9282.06 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 180 (n=102, 90) | 7016.5 titers | Standard Deviation 6945.59 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 30 (n=110, 100) | 8561.7 titers | Standard Deviation 9323.91 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 360 (n=83, 74) | 10284.1 titers | Standard Deviation 12175.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 90 Cohort (n=110, 99) | 8930.2 titers | Standard Deviation 9002.57 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 270 Cohort (n=94, 73) | 11976.7 titers | Standard Deviation 13679.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Day 90 (n=110, 99) | 7497.8 titers | Standard Deviation 7356.42 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 360 Cohort (n=83, 74) | 11712.4 titers | Standard Deviation 12971.16 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | Baseline for Day 180 Cohort (n=102, 90) | 8689.3 titers | Standard Deviation 8626.9 |
Secondary
Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region
Time frame: Baseline, Days 30, 90, 180, 270, 360
Population: Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 30 Cohort (n=110, 101) | 12.6 titers | Standard Deviation 9.59 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 30 (n=110, 101) | 12.5 titers | Standard Deviation 9.38 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 90 Cohort (n=110, 99) | 12.5 titers | Standard Deviation 9.42 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 90 (n=110, 99) | 12.0 titers | Standard Deviation 8.31 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 180 Cohort (n=102, 90) | 12.6 titers | Standard Deviation 9.91 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 180 (n=102, 90) | 12.1 titers | Standard Deviation 8.66 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 270 Cohort (n=95, 73) | 13.4 titers | Standard Deviation 10.51 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 270 (n=95, 73) | 12.5 titers | Standard Deviation 8.7 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 360 Cohort (n=84, 76) | 13.6 titers | Standard Deviation 11.03 |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 360 (n=84, 76) | 12.9 titers | Standard Deviation 9.79 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 270 (n=95, 73) | 11.7 titers | Standard Deviation 4.42 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 30 Cohort (n=110, 101) | 11.7 titers | Standard Deviation 4.79 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 180 (n=102, 90) | 11.7 titers | Standard Deviation 5.01 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 30 (n=110, 101) | 12.0 titers | Standard Deviation 5.58 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 360 (n=84, 76) | 11.6 titers | Standard Deviation 4.42 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 90 Cohort (n=110, 99) | 11.6 titers | Standard Deviation 4.69 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 270 Cohort (n=95, 73) | 12.1 titers | Standard Deviation 5.22 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Day 90 (n=110, 99) | 11.4 titers | Standard Deviation 3.96 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 360 Cohort (n=84, 76) | 12.2 titers | Standard Deviation 5.77 |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | Baseline for Day 180 Cohort (n=102, 90) | 11.6 titers | Standard Deviation 4.76 |
Secondary
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)
Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Time frame: Baseline, Days 30, 90, 180, 270, 360
Population: Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio <3 to <=9 (n=110, 99) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio >9 (n=102, 90) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio <3 to <=9 (n=110, 100) | 1 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio <=3 (n=94, 73) | 94 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio >9 (n=110, 99) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio <3 to <=9 (n=94, 73) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio <=3 (n=110, 99) | 110 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio >9 (n=94, 73) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio <=3 (n=102, 90) | 101 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio <=3 (n=83, 74) | 81 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio >9 (n=110, 100) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio <3 to <=9 (n=83, 74) | 2 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio <3 to <=9 (n=102, 90) | 1 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio >9 (n=83, 74) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio <=3 (n=110, 100) | 109 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio >9 (n=83, 74) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio <=3 (n=110, 100) | 100 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio <3 to <=9 (n=110, 100) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 30, ratio >9 (n=110, 100) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio <=3 (n=110, 99) | 99 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio <3 to <=9 (n=110, 99) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 90, ratio >9 (n=110, 99) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio <=3 (n=102, 90) | 90 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio <3 to <=9 (n=102, 90) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 180, ratio >9 (n=102, 90) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio <=3 (n=94, 73) | 73 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio <3 to <=9 (n=94, 73) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 270, ratio >9 (n=94, 73) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio <=3 (n=83, 74) | 72 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region) | Day 360, ratio <3 to <=9 (n=83, 74) | 2 participants |
Secondary
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)
Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Time frame: Baseline, Days 30, 90, 180, 270, 360
Population: Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio <3 to <=9 (n=110, 99) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio >9 (n=102, 90) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio <3 to <=9 (n=110, 101) | 1 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio <=3 (n=95, 73) | 95 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio >9 (n=110, 99) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio <3 to <=9 (n=95, 73) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio <=3 (n=110, 99) | 110 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio >9 (n=95, 73) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio <=3 (n=102, 90) | 101 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio <=3 (n=84, 76) | 84 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio >9 (n=110, 101) | 1 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio <3 to <=9 (n=84, 76) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio <3 to <=9 (n=102, 90) | 1 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio >9 (n=84, 76) | 0 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio <=3 (n=110, 101) | 108 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio >9 (n=84, 76) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio <=3 (n=110, 101) | 99 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio <3 to <=9 (n=110, 101) | 2 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 30, ratio >9 (n=110, 101) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio <=3 (n=110, 99) | 99 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio <3 to <=9 (n=110, 99) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 90, ratio >9 (n=110, 99) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio <=3 (n=102, 90) | 89 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio <3 to <=9 (n=102, 90) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 180, ratio >9 (n=102, 90) | 1 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio <=3 (n=95, 73) | 73 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio <3 to <=9 (n=95, 73) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 270, ratio >9 (n=95, 73) | 0 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio <=3 (n=84, 76) | 76 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region) | Day 360, ratio <3 to <=9 (n=84, 76) | 0 participants |
Secondary
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180
Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
Time frame: Baseline, Day 180
Population: Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Swollen Joints (n=114, 104, 118) | 55.3 percentage change | Standard Error 3.5 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Subject Global Assessment (n=111, 103, 118) | 40.8 percentage change | Standard Error 4.7 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | SAPF (n=107, 98, 110) | 41.2 percentage change | Standard Error 4.6 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Tender Joints (n=114, 104, 118) | 59.8 percentage change | Standard Error 3.6 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | C-Reactive Protein (n=108, 98, 114) | 31.8 percentage change | Standard Error 6.3 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Physician Global Assessment (n=111, 103, 116) | 51.9 percentage change | Standard Error 3.4 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Pain (n=109, 102, 118) | 46.2 percentage change | Standard Error 4.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | SAPF (n=107, 98, 110) | 21.6 percentage change | Standard Error 6.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Tender Joints (n=114, 104, 118) | 43.2 percentage change | Standard Error 4.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Swollen Joints (n=114, 104, 118) | 45.3 percentage change | Standard Error 4.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Pain (n=109, 102, 118) | 22.1 percentage change | Standard Error 5.8 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Subject Global Assessment (n=111, 103, 118) | 9.1 percentage change | Standard Error 10.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Physician Global Assessment (n=111, 103, 116) | 38.7 percentage change | Standard Error 4.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | C-Reactive Protein (n=108, 98, 114) | 16.4 percentage change | Standard Error 7 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Subject Global Assessment (n=111, 103, 118) | 17.5 percentage change | Standard Error 4.1 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Swollen Joints (n=114, 104, 118) | 33.5 percentage change | Standard Error 4.3 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | C-Reactive Protein (n=108, 98, 114) | -23.4 percentage change | Standard Error 11 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Physician Global Assessment (n=111, 103, 116) | 25.1 percentage change | Standard Error 3.5 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | SAPF (n=107, 98, 110) | 13.7 percentage change | Standard Error 5.5 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Pain (n=109, 102, 118) | 8.2 percentage change | Standard Error 7 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180 | Tender Joints (n=114, 104, 118) | 31.9 percentage change | Standard Error 5 |
Secondary
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360
Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
Time frame: Baseline, Day 360
Population: Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Swollen Joints (n=114, 104, 118) | 59.7 percentage change | Standard Error 3.7 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Subject Global Assessment (n=111, 103, 118) | 41.0 percentage change | Standard Error 5.1 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | SAPF (n=107, 98, 110) | 42.3 percentage change | Standard Error 4.3 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Tender Joints (n=114, 104, 118) | 66.4 percentage change | Standard Error 3.8 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | C-Reactive Protein (n=108, 98, 114) | 27.6 percentage change | Standard Error 9.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Physician Global Assessment (n=111, 103, 116) | 53.5 percentage change | Standard Error 3.4 |
| DB Abatacept 10 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Pain (n=109, 102, 118) | 44.9 percentage change | Standard Error 4.7 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | SAPF (n=107, 98, 110) | 22.9 percentage change | Standard Error 5 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Tender Joints (n=114, 104, 118) | 43.6 percentage change | Standard Error 4.3 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Swollen Joints (n=114, 104, 118) | 46.4 percentage change | Standard Error 4.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Pain (n=109, 102, 118) | 26.2 percentage change | Standard Error 5.9 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Subject Global Assessment (n=111, 103, 118) | 16.0 percentage change | Standard Error 8.9 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Physician Global Assessment (n=111, 103, 116) | 37.9 percentage change | Standard Error 4.2 |
| DB Abatacept 2 mg/kg + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | C-Reactive Protein (n=108, 98, 114) | 11.0 percentage change | Standard Error 9.5 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Subject Global Assessment (n=111, 103, 118) | 2.0 percentage change | Standard Error 19.1 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Swollen Joints (n=114, 104, 118) | 36.2 percentage change | Standard Error 4.4 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | C-Reactive Protein (n=108, 98, 114) | -31.3 percentage change | Standard Error 12.6 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Physician Global Assessment (n=111, 103, 116) | 24.1 percentage change | Standard Error 3.8 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | SAPF (n=107, 98, 110) | 10.3 percentage change | Standard Error 5.9 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Pain (n=109, 102, 118) | 65.2 percentage change | Standard Error 12.6 |
| DB Placebo + Methotrexate | Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360 | Tender Joints (n=114, 104, 118) | 30.0 percentage change | Standard Error 5.3 |
Secondary
Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 30.47 Units on a Scale | Standard Deviation 9.43 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 18, 16) | 34.97 Units on a Scale | Standard Deviation 9.74 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 31.41 Units on a Scale | Standard Deviation 10.16 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 30.96 Units on a Scale | Standard Deviation 9.74 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 29.84 Units on a Scale | Standard Deviation 9.57 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 31.77 Units on a Scale | Standard Deviation 10.62 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 30.27 Units on a Scale | Standard Deviation 9.38 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 30.39 Units on a Scale | Standard Deviation 9.63 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 31.47 Units on a Scale | Standard Deviation 10.64 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 31.81 Units on a Scale | Standard Deviation 10.45 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 30.18 Units on a Scale | Standard Deviation 10.23 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 30.58 Units on a Scale | Standard Deviation 9.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 31.21 Units on a Scale | Standard Deviation 10.35 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 31.50 Units on a Scale | Standard Deviation 10.12 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 32.24 Units on a Scale | Standard Deviation 10.42 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 32.79 Units on a Scale | Standard Deviation 10.26 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 33.56 Units on a Scale | Standard Deviation 10.07 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 18, 16) | 33.92 Units on a Scale | Standard Deviation 9.55 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 30.95 Units on a Scale | Standard Deviation 8.95 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 30.80 Units on a Scale | Standard Deviation 9.48 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 32.04 Units on a Scale | Standard Deviation 8.95 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 30.79 Units on a Scale | Standard Deviation 9.1 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 18, 16) | 32.37 Units on a Scale | Standard Deviation 10.37 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 31.48 Units on a Scale | Standard Deviation 9.08 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 31.26 Units on a Scale | Standard Deviation 9.15 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 32.18 Units on a Scale | Standard Deviation 9.32 |
| DB Placebo + Methotrexate | Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 31.56 Units on a Scale | Standard Deviation 9.51 |
Secondary
Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 35.28 Units on a Scale | Standard Deviation 8.59 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 38.83 Units on a Scale | Standard Deviation 9.6 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 35.57 Units on a Scale | Standard Deviation 9.35 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 36.22 Units on a Scale | Standard Deviation 8.94 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 35.91 Units on a Scale | Standard Deviation 8.52 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 35.12 Units on a Scale | Standard Deviation 9.68 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baselinefor Day 1080 cohort (n=64, 50, 49) | 36.06 Units on a Scale | Standard Deviation 8.73 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 36.10 Units on a Scale | Standard Deviation 8.76 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 35.35 Units on a Scale | Standard Deviation 9.49 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 34.57 Units on a Scale | Standard Deviation 8.23 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 33.82 Units on a Scale | Standard Deviation 7.69 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 34.23 Units on a Scale | Standard Deviation 7.63 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baselinefor Day 1080 cohort (n=64, 50, 49) | 34.57 Units on a Scale | Standard Deviation 7.84 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 34.56 Units on a Scale | Standard Deviation 7.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 34.50 Units on a Scale | Standard Deviation 8.27 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 35.29 Units on a Scale | Standard Deviation 8.32 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 35.76 Units on a Scale | Standard Deviation 8.27 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 35.75 Units on a Scale | Standard Deviation 7.82 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baselinefor Day 1080 cohort (n=64, 50, 49) | 36.04 Units on a Scale | Standard Deviation 7.48 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 36.39 Units on a Scale | Standard Deviation 7.98 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 35.32 Units on a Scale | Standard Deviation 7.73 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 35.93 Units on a Scale | Standard Deviation 7.35 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 37.72 Units on a Scale | Standard Deviation 8.69 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 35.54 Units on a Scale | Standard Deviation 7.27 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 35.42 Units on a Scale | Standard Deviation 7.37 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 35.29 Units on a Scale | Standard Deviation 8.03 |
| DB Placebo + Methotrexate | Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 35.59 Units on a Scale | Standard Deviation 7.65 |
Secondary
Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period
SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 45.32 Units on a Scale | Standard Deviation 11.38 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 46.24 Units on a Scale | Standard Deviation 13.26 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 45.57 Units on a Scale | Standard Deviation 11.45 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 45.07 Units on a Scale | Standard Deviation 11.31 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 360 cohort (n=84, 66, 64) | 46.27 Units on a Scale | Standard Deviation 12.13 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 45.48 Units on a Scale | Standard Deviation 11.45 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 45.45 Units on a Scale | Standard Deviation 11.76 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 720 cohort (n=73,55, 53) | 46.17 Units on a Scale | Standard Deviation 12.24 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 46.35 Units on a Scale | Standard Deviation 12.07 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 41.87 Units on a Scale | Standard Deviation 12.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 360 cohort (n=84, 66, 64) | 42.10 Units on a Scale | Standard Deviation 13.08 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 720 cohort (n=73,55, 53) | 41.82 Units on a Scale | Standard Deviation 13.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 42.10 Units on a Scale | Standard Deviation 12.82 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 42.48 Units on a Scale | Standard Deviation 13.06 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 42.09 Units on a Scale | Standard Deviation 12.96 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 42.53 Units on a Scale | Standard Deviation 13.34 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 40.74 Units on a Scale | Standard Deviation 12.02 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 40.94 Units on a Scale | Standard Deviation 13.47 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 44.53 Units on a Scale | Standard Deviation 12.52 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 360 cohort (n=84, 66, 64) | 44.44 Units on a Scale | Standard Deviation 12.36 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 44.51 Units on a Scale | Standard Deviation 12.09 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline (Day 0) for Day 720 cohort (n=73,55, 53) | 44.74 Units on a Scale | Standard Deviation 12.62 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 45.14 Units on a Scale | Standard Deviation 12.42 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 44.68 Units on a Scale | Standard Deviation 12.85 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 44.66 Units on a Scale | Standard Deviation 12.74 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 43.51 Units on a Scale | Standard Deviation 11.2 |
| DB Placebo + Methotrexate | Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 43.89 Units on a Scale | Standard Deviation 12.36 |
Secondary
Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 44.24 Units on a Scale | Standard Deviation 11.09 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 44.89 Units on a Scale | Standard Deviation 11.85 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 44.79 Units on a Scale | Standard Deviation 11.18 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 44.13 Units on a Scale | Standard Deviation 11.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 44.66 Units on a Scale | Standard Deviation 11.94 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 44.87 Units on a Scale | Standard Deviation 9.92 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 44.13 Units on a Scale | Standard Deviation 11.82 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 44.53 Units on a Scale | Standard Deviation 12.19 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baselinefor Day 2520 cohort (n=38, 36, 33) | 45.54 Units on a Scale | Standard Deviation 11.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 40.78 Units on a Scale | Standard Deviation 12.39 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 41.29 Units on a Scale | Standard Deviation 12.28 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 40.49 Units on a Scale | Standard Deviation 12.72 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 40.81 Units on a Scale | Standard Deviation 12.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 41.11 Units on a Scale | Standard Deviation 12.61 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 40.50 Units on a Scale | Standard Deviation 12.17 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baselinefor Day 2520 cohort (n=38, 36, 33) | 42.05 Units on a Scale | Standard Deviation 12.54 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 39.77 Units on a Scale | Standard Deviation 10.76 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 39.49 Units on a Scale | Standard Deviation 11.62 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 41.44 Units on a Scale | Standard Deviation 11.55 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 42.35 Units on a Scale | Standard Deviation 11.62 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baselinefor Day 2520 cohort (n=38, 36, 33) | 41.06 Units on a Scale | Standard Deviation 11.44 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 41.99 Units on a Scale | Standard Deviation 11.58 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 40.18 Units on a Scale | Standard Deviation 12.07 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 41.50 Units on a Scale | Standard Deviation 11.78 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 41.60 Units on a Scale | Standard Deviation 11.77 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 40.24 Units on a Scale | Standard Deviation 10.92 |
| DB Placebo + Methotrexate | Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 40.89 Units on a Scale | Standard Deviation 11.05 |
Secondary
Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 31.46 Units on a Scale | Standard Deviation 8.31 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 36.81 Units on a Scale | Standard Deviation 7.68 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 32.15 Units on a Scale | Standard Deviation 8.72 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 32.19 Units on a Scale | Standard Deviation 8.72 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 64) | 30.90 Units on a Scale | Standard Deviation 8.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 32.63 Units on a Scale | Standard Deviation 8.71 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 31.56 Units on a Scale | Standard Deviation 8.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 31.44 Units on a Scale | Standard Deviation 8.35 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 31.93 Units on a Scale | Standard Deviation 9.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 32.02 Units on a Scale | Standard Deviation 8.91 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 64) | 31.03 Units on a Scale | Standard Deviation 8.87 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 30.83 Units on a Scale | Standard Deviation 8.03 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 31.73 Units on a Scale | Standard Deviation 8.63 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 31.80 Units on a Scale | Standard Deviation 8.84 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 32.25 Units on a Scale | Standard Deviation 9.07 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 32.75 Units on a Scale | Standard Deviation 9.2 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 33.65 Units on a Scale | Standard Deviation 8.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 33.88 Units on a Scale | Standard Deviation 9.12 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 32.38 Units on a Scale | Standard Deviation 7.08 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 64) | 32.57 Units on a Scale | Standard Deviation 7.94 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 32.54 Units on a Scale | Standard Deviation 7.39 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 32.48 Units on a Scale | Standard Deviation 7.14 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 17, 16) | 33.40 Units on a Scale | Standard Deviation 9.52 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 32.36 Units on a Scale | Standard Deviation 7.57 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 32.20 Units on a Scale | Standard Deviation 7.44 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 32.66 Units on a Scale | Standard Deviation 7.81 |
| DB Placebo + Methotrexate | Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 32.29 Units on a Scale | Standard Deviation 7.7 |
Secondary
Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 38.84 Units on a Scale | Standard Deviation 13.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 40.47 Units on a Scale | Standard Deviation 14.93 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 38.72 Units on a Scale | Standard Deviation 14.29 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 38.76 Units on a Scale | Standard Deviation 13.97 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 64) | 40.29 Units on a Scale | Standard Deviation 14.09 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 38.10 Units on a Scale | Standard Deviation 14.62 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 39.21 Units on a Scale | Standard Deviation 13.92 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 40.19 Units on a Scale | Standard Deviation 14.04 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 39.54 Units on a Scale | Standard Deviation 14.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 36.97 Units on a Scale | Standard Deviation 14.19 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 64) | 36.63 Units on a Scale | Standard Deviation 14.3 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 36.15 Units on a Scale | Standard Deviation 14.08 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 37.01 Units on a Scale | Standard Deviation 14.09 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 37.48 Units on a Scale | Standard Deviation 14.02 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 37.78 Units on a Scale | Standard Deviation 14.02 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 37.88 Units on a Scale | Standard Deviation 14.21 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 36.73 Units on a Scale | Standard Deviation 14.29 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 37.78 Units on a Scale | Standard Deviation 14.45 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 39.43 Units on a Scale | Standard Deviation 14.76 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 64) | 38.88 Units on a Scale | Standard Deviation 14.28 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 40.34 Units on a Scale | Standard Deviation 14.67 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 38.84 Units on a Scale | Standard Deviation 14.68 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 44.15 Units on a Scale | Standard Deviation 14.12 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 39.29 Units on a Scale | Standard Deviation 14.76 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 39.30 Units on a Scale | Standard Deviation 14.81 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 39.37 Units on a Scale | Standard Deviation 14.62 |
| DB Placebo + Methotrexate | Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 39.09 Units on a Scale | Standard Deviation 14.97 |
Secondary
Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 33.74 Units on a Scale | Standard Deviation 9.6 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 33.85 Units on a Scale | Standard Deviation 9.79 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 34.36 Units on a Scale | Standard Deviation 10.22 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 37.52 Units on a Scale | Standard Deviation 11.71 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 33.97 Units on a Scale | Standard Deviation 9.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 66) | 33.68 Units on a Scale | Standard Deviation 9.66 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 33.72 Units on a Scale | Standard Deviation 9.85 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 33.61 Units on a Scale | Standard Deviation 9.61 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 34.06 Units on a Scale | Standard Deviation 10.09 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 33.26 Units on a Scale | Standard Deviation 8.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 33.41 Units on a Scale | Standard Deviation 8.93 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 66) | 31.70 Units on a Scale | Standard Deviation 7.77 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 31.49 Units on a Scale | Standard Deviation 7.51 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 32.20 Units on a Scale | Standard Deviation 7.96 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 32.57 Units on a Scale | Standard Deviation 8.2 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 32.39 Units on a Scale | Standard Deviation 8.31 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 34.63 Units on a Scale | Standard Deviation 8.57 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 33.38 Units on a Scale | Standard Deviation 8.45 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 35.47 Units on a Scale | Standard Deviation 9.82 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 33.01 Units on a Scale | Standard Deviation 8.01 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 66, 66) | 34.17 Units on a Scale | Standard Deviation 8.82 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 33.43 Units on a Scale | Standard Deviation 7.9 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 33.95 Units on a Scale | Standard Deviation 8.68 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 33.58 Units on a Scale | Standard Deviation 8.42 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 32.80 Units on a Scale | Standard Deviation 7.63 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 33.10 Units on a Scale | Standard Deviation 7.98 |
| DB Placebo + Methotrexate | Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 33.69 Units on a Scale | Standard Deviation 8.78 |
Secondary
Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period
Serum evaluations were carried out to evaluate participant serum CRP concentrations at 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: Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1440 cohort (n=56, 46, 41) | 2.65 mg/dL | Standard Deviation 2.02 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 3060 cohort (n=14, 10, 8) | 1.93 mg/dL | Standard Deviation 1.12 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2160 cohort (n=43, 34, 33) | 2.34 mg/dL | Standard Deviation 1.66 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1800 cohort (n=52, 41, 41) | 2.40 mg/dL | Standard Deviation 1.73 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 360 cohort (n=78, 65, 65) | 2.90 mg/dL | Standard Deviation 2.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2880 cohort (n=27, 26, 27) | 2.14 mg/dL | Standard Deviation 1.42 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1080 cohort (n=61, 50, 47) | 2.58 mg/dL | Standard Deviation 1.99 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 720 cohort (n=68, 54, 53) | 2.64 mg/dL | Standard Deviation 2.03 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2520 cohort (n=36, 35, 32) | 2.46 mg/dL | Standard Deviation 1.7 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1800 cohort (n=52, 41, 41) | 3.10 mg/dL | Standard Deviation 2.75 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 360 cohort (n=78, 65, 65) | 3.02 mg/dL | Standard Deviation 2.36 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 720 cohort (n=68, 54, 53) | 3.16 mg/dL | Standard Deviation 2.6 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1080 cohort (n=61, 50, 47) | 3.06 mg/dL | Standard Deviation 2.63 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1440 cohort (n=56, 46, 41) | 3.11 mg/dL | Standard Deviation 2.71 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2160 cohort (n=43, 34, 33) | 2.91 mg/dL | Standard Deviation 2.77 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2520 cohort (n=36, 35, 32) | 3.02 mg/dL | Standard Deviation 2.79 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2880 cohort (n=27, 26, 27) | 2.95 mg/dL | Standard Deviation 3 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 3060 cohort (n=14, 10, 8) | 2.99 mg/dL | Standard Deviation 3.07 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1080 cohort (n=61, 50, 47) | 2.52 mg/dL | Standard Deviation 2.06 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 360 cohort (n=78, 65, 65) | 2.61 mg/dL | Standard Deviation 2.2 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2520 cohort (n=36, 35, 32) | 2.86 mg/dL | Standard Deviation 2.35 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 720 cohort (n=68, 54, 53) | 2.60 mg/dL | Standard Deviation 2.03 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 3060 cohort (n=14, 10, 8) | 2.72 mg/dL | Standard Deviation 1.3 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1800 cohort (n=52, 41, 41) | 2.64 mg/dL | Standard Deviation 2.15 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 1440 cohort (n=56, 46, 41) | 2.62 mg/dL | Standard Deviation 2.16 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2880 cohort (n=27, 26, 27) | 3.08 mg/dL | Standard Deviation 2.49 |
| DB Placebo + Methotrexate | Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period | Baseline for Day 2160 cohort (n=43, 34, 33) | 2.80 mg/dL | Standard Deviation 2.36 |
Secondary
Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 38.77 Units on a Scale | Standard Deviation 11.04 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 42.77 Units on a Scale | Standard Deviation 11.66 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 39.16 Units on a Scale | Standard Deviation 11.45 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 38.84 Units on a Scale | Standard Deviation 11.52 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 38.59 Units on a Scale | Standard Deviation 10.99 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 39.54 Units on a Scale | Standard Deviation 12.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 38.99 Units on a Scale | Standard Deviation 11.04 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 39.37 Units on a Scale | Standard Deviation 11.13 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 39.42 Units on a Scale | Standard Deviation 11.82 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 34.92 Units on a Scale | Standard Deviation 9.54 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 34.45 Units on a Scale | Standard Deviation 10.52 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 35.04 Units on a Scale | Standard Deviation 9.81 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 34.77 Units on a Scale | Standard Deviation 9.22 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 35.19 Units on a Scale | Standard Deviation 9.36 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 35.42 Units on a Scale | Standard Deviation 9.54 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 35.11 Units on a Scale | Standard Deviation 9.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 36.33 Units on a Scale | Standard Deviation 8.8 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 36.33 Units on a Scale | Standard Deviation 8.78 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=64, 50, 49) | 39.08 Units on a Scale | Standard Deviation 10.71 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 38.14 Units on a Scale | Standard Deviation 10.91 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 35, 33) | 38.88 Units on a Scale | Standard Deviation 10.93 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 56, 53) | 39.11 Units on a Scale | Standard Deviation 10.74 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=17, 18, 16) | 38.82 Units on a Scale | Standard Deviation 12.52 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 39.04 Units on a Scale | Standard Deviation 11.03 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=60, 46, 44) | 38.88 Units on a Scale | Standard Deviation 11.05 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 38.40 Units on a Scale | Standard Deviation 10.75 |
| DB Placebo + Methotrexate | Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 36, 35) | 38.06 Units on a Scale | Standard Deviation 10.97 |
Secondary
Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period
Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Time frame: Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1440 cohort (n=47, 36, 31) | 1418.64 pg/mL | Standard Deviation 806.85 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1080 cohort (n=57, 47, 44) | 1413.28 pg/mL | Standard Deviation 760.39 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 360 cohort (n=69, 57, 58) | 1424.86 pg/mL | Standard Deviation 790.75 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 720 cohort (n=66, 53, 49) | 1419.82 pg/mL | Standard Deviation 721 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1800 cohort (n=27, 13, 17) | 1252.04 pg/mL | Standard Deviation 572.14 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1080 cohort (n=57, 47, 44) | 1341.51 pg/mL | Standard Deviation 520.06 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 360 cohort (n=69, 57, 58) | 1365.40 pg/mL | Standard Deviation 524.9 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 720 cohort (n=66, 53, 49) | 1351.15 pg/mL | Standard Deviation 497.64 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1440 cohort (n=47, 36, 31) | 1323.14 pg/mL | Standard Deviation 538.82 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1800 cohort (n=27, 13, 17) | 1160.15 pg/mL | Standard Deviation 444.37 |
| DB Placebo + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1800 cohort (n=27, 13, 17) | 1476.06 pg/mL | Standard Deviation 590.14 |
| DB Placebo + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1440 cohort (n=47, 36, 31) | 1409.71 pg/mL | Standard Deviation 687.86 |
| DB Placebo + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 360 cohort (n=69, 57, 58) | 1480.93 pg/mL | Standard Deviation 713.88 |
| DB Placebo + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 1080 cohort (n=57, 47, 44) | 1392.09 pg/mL | Standard Deviation 678.85 |
| DB Placebo + Methotrexate | Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period | Baseline for Day 720 cohort (n=66, 53, 49) | 1437.24 pg/mL | Standard Deviation 730.73 |
Secondary
Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 40.84 Units on a Scale | Standard Deviation 8.17 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 44.06 Units on a Scale | Standard Deviation 8.66 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 41.66 Units on a Scale | Standard Deviation 8.59 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 41.09 Units on a Scale | Standard Deviation 8.27 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 41.17 Units on a Scale | Standard Deviation 8.29 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 42.12 Units on a Scale | Standard Deviation 8.8 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 40.65 Units on a Scale | Standard Deviation 8.24 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 41.15 Units on a Scale | Standard Deviation 8.29 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 36, 33) | 41.66 Units on a Scale | Standard Deviation 9.03 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 41.40 Units on a Scale | Standard Deviation 8.72 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 40.68 Units on a Scale | Standard Deviation 8.84 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 41.22 Units on a Scale | Standard Deviation 8.25 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 41.72 Units on a Scale | Standard Deviation 8.56 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 41.85 Units on a Scale | Standard Deviation 8.81 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 40.93 Units on a Scale | Standard Deviation 8.65 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 36, 33) | 41.43 Units on a Scale | Standard Deviation 9.26 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 40.22 Units on a Scale | Standard Deviation 8.22 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 41.12 Units on a Scale | Standard Deviation 7.29 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1080 cohort (n=63, 50, 49) | 42.58 Units on a Scale | Standard Deviation 9.81 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 360 cohort (n=84, 67, 66) | 42.49 Units on a Scale | Standard Deviation 9.81 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2520 cohort (n=38, 36, 33) | 42.74 Units on a Scale | Standard Deviation 9.64 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 720 cohort (n=73, 55, 53) | 43.25 Units on a Scale | Standard Deviation 9.84 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 3060 cohort (n=18, 17, 16) | 42.40 Units on a Scale | Standard Deviation 9.2 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1800 cohort (n=54, 43, 42) | 43.42 Units on a Scale | Standard Deviation 9.83 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 1440 cohort (n=59, 46, 44) | 43.08 Units on a Scale | Standard Deviation 9.81 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2880 cohort (n=33, 30, 31) | 42.34 Units on a Scale | Standard Deviation 9.57 |
| DB Placebo + Methotrexate | Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period | Baseline for Day 2160 cohort (n=45, 37, 35) | 42.77 Units on a Scale | Standard Deviation 10.04 |
Secondary
Mean BL General Health Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,440 cohort (n=60, 46, 44) | 37.41 Units on a Scale | Standard Deviation 9.12 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 3,060 cohort (n=18, 18, 16) | 41.37 Units on a Scale | Standard Deviation 11.49 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,160 cohort (n=45, 37, 35) | 38.81 Units on a Scale | Standard Deviation 9.94 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,800 cohort (n=54, 43, 42) | 38.08 Units on a Scale | Standard Deviation 9.75 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 360 cohort (n=84, 67, 66) | 37.11 Units on a Scale | Standard Deviation 9.23 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,880 cohort (n=33, 30, 31) | 40.09 Units on a Scale | Standard Deviation 10.49 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,080 cohort (n=64, 50, 49) | 37.55 Units on a Scale | Standard Deviation 9.38 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 720 cohort (n=73, 56, 53) | 37.36 Units on a Scale | Standard Deviation 9.3 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,520 cohort (n=38, 36, 33) | 39.25 Units on a Scale | Standard Deviation 10.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,800 cohort (n=54, 43, 42) | 35.60 Units on a Scale | Standard Deviation 8.98 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 360 cohort (n=84, 67, 66) | 35.87 Units on a Scale | Standard Deviation 9.23 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 720 cohort (n=73, 56, 53) | 35.61 Units on a Scale | Standard Deviation 8.96 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,080 cohort (n=64, 50, 49) | 35.78 Units on a Scale | Standard Deviation 9.13 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,440 cohort (n=60, 46, 44) | 35.67 Units on a Scale | Standard Deviation 8.88 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,160 cohort (n=45, 37, 35) | 35.69 Units on a Scale | Standard Deviation 8.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,520 cohort (n=38, 36, 33) | 36.17 Units on a Scale | Standard Deviation 9.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,880 cohort (n=33, 30, 31) | 35.39 Units on a Scale | Standard Deviation 8.54 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 3,060 cohort (n=18, 18, 16) | 33.88 Units on a Scale | Standard Deviation 8.58 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,080 cohort (n=64, 50, 49) | 37.45 Units on a Scale | Standard Deviation 8.37 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 360 cohort (n=84, 67, 66) | 37.45 Units on a Scale | Standard Deviation 9.01 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,520 cohort (n=38, 36, 33) | 36.98 Units on a Scale | Standard Deviation 8.5 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 720 cohort (n=73, 56, 53) | 38.06 Units on a Scale | Standard Deviation 8.26 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 3,060 cohort (n=18, 18, 16) | 36.84 Units on a Scale | Standard Deviation 9.18 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,800 cohort (n=54, 43, 42) | 37.78 Units on a Scale | Standard Deviation 8.59 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 1,440 cohort (n=60, 46, 44) | 37.64 Units on a Scale | Standard Deviation 8.6 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,880 cohort (n=33, 30, 31) | 36.57 Units on a Scale | Standard Deviation 8.54 |
| DB Placebo + Methotrexate | Mean BL General Health Domain of the SF-36 Over Time in OL Period | BL (Day 0) for Day 2,160 cohort (n=45, 37, 35) | 36.93 Units on a Scale | Standard Deviation 8.65 |
Secondary
Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 6.98 Units on a Scale | Standard Error 0.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.27 Units on a Scale | Standard Error 1.4 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 6.18 Units on a Scale | Standard Error 1.12 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 5.96 Units on a Scale | Standard Error 1.06 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.42 Units on a Scale | Standard Error 1.85 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.52 Units on a Scale | Standard Error 1.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 5.09 Units on a Scale | Standard Error 2.73 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.37 Units on a Scale | Standard Error 2.05 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 5.84 Units on a Scale | Standard Error 1.12 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 5.99 Units on a Scale | Standard Error 1.24 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.51 Units on a Scale | Standard Error 1.21 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 8.67 Units on a Scale | Standard Error 1.45 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 6.82 Units on a Scale | Standard Error 2.21 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 6.08 Units on a Scale | Standard Error 1.05 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 6.27 Units on a Scale | Standard Error 1.07 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 8.01 Units on a Scale | Standard Error 0.91 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.87 Units on a Scale | Standard Error 1.26 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 8.73 Units on a Scale | Standard Error 1.3 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 3.88 Units on a Scale | Standard Error 1.46 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 5.38 Units on a Scale | Standard Error 1.43 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 4.80 Units on a Scale | Standard Error 1.17 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 5.61 Units on a Scale | Standard Error 1.3 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.38 Units on a Scale | Standard Error 1.56 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 5.09 Units on a Scale | Standard Error 0.96 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 3.48 Units on a Scale | Standard Error 0.71 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 3.97 Units on a Scale | Standard Error 1.25 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 5.63 Units on a Scale | Standard Error 1.05 |
Secondary
Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.
Time frame: Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 4.67 Units on a Scale | Standard Error 1.31 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 17, 16) | 4.81 Units on a Scale | Standard Error 2.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 6.22 Units on a Scale | Standard Error 1.47 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 5.32 Units on a Scale | Standard Error 1.38 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 64) | 6.05 Units on a Scale | Standard Error 1.19 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 5.00 Units on a Scale | Standard Error 1.92 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 4.01 Units on a Scale | Standard Error 1.23 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73,55, 53) | 4.59 Units on a Scale | Standard Error 1.29 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 2.81 Units on a Scale | Standard Error 1.85 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 4.59 Units on a Scale | Standard Error 1.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 64) | 6.03 Units on a Scale | Standard Error 1.32 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73,55, 53) | 6.02 Units on a Scale | Standard Error 1.49 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 4.87 Units on a Scale | Standard Error 1.44 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 6.68 Units on a Scale | Standard Error 1.34 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 5.95 Units on a Scale | Standard Error 1.46 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 7.34 Units on a Scale | Standard Error 1.75 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.97 Units on a Scale | Standard Error 1.69 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 17, 16) | 5.51 Units on a Scale | Standard Error 2.88 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 5.52 Units on a Scale | Standard Error 1.78 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 64) | 2.53 Units on a Scale | Standard Error 1.34 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 4.44 Units on a Scale | Standard Error 2.26 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73,55, 53) | 4.17 Units on a Scale | Standard Error 1.57 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 17, 16) | 1.91 Units on a Scale | Standard Error 3.26 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 2.26 Units on a Scale | Standard Error 1.71 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 4.76 Units on a Scale | Standard Error 2.12 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 3.87 Units on a Scale | Standard Error 2.18 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 4.55 Units on a Scale | Standard Error 2.19 |
Secondary
Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 4.81 Units on a Scale | Standard Error 1.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 2.65 Units on a Scale | Standard Error 2.35 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.82 Units on a Scale | Standard Error 1.33 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 4.47 Units on a Scale | Standard Error 1.34 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 5.41 Units on a Scale | Standard Error 1.1 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 4.96 Units on a Scale | Standard Error 1.71 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 4.62 Units on a Scale | Standard Error 1.03 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 4.22 Units on a Scale | Standard Error 1.18 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 3.15 Units on a Scale | Standard Error 1.92 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 5.44 Units on a Scale | Standard Error 1.45 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 5.74 Units on a Scale | Standard Error 1.14 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 5.49 Units on a Scale | Standard Error 1.29 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 5.41 Units on a Scale | Standard Error 1.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 5.96 Units on a Scale | Standard Error 1.24 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.96 Units on a Scale | Standard Error 1.26 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.06 Units on a Scale | Standard Error 1.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.30 Units on a Scale | Standard Error 1.6 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 4.68 Units on a Scale | Standard Error 2.59 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 5.54 Units on a Scale | Standard Error 1.59 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 2.60 Units on a Scale | Standard Error 1.13 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.33 Units on a Scale | Standard Error 1.94 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 4.59 Units on a Scale | Standard Error 1.5 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 6.99 Units on a Scale | Standard Error 2.68 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 3.15 Units on a Scale | Standard Error 1.8 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 5.59 Units on a Scale | Standard Error 1.93 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.78 Units on a Scale | Standard Error 1.98 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.29 Units on a Scale | Standard Error 1.94 |
Secondary
Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1440 (n=59, 46, 44) | 8.18 Units on a Scale | Standard Error 1.33 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 3060 (n=17, 17, 16) | 8.55 Units on a Scale | Standard Error 2.74 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2160 (n=45, 36, 35) | 9.51 Units on a Scale | Standard Error 1.72 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1800 (n=54, 43, 42) | 9.30 Units on a Scale | Standard Error 1.49 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 360 (n=84, 66, 64) | 9.66 Units on a Scale | Standard Error 1.05 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2880 (n=33, 30, 31) | 10.97 Units on a Scale | Standard Error 1.96 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1080 (n=63, 50, 49) | 9.28 Units on a Scale | Standard Error 1.22 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 720 (n=73, 55, 53) | 9.15 Units on a Scale | Standard Error 1.17 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2520 (n=38, 35, 33) | 10.12 Units on a Scale | Standard Error 1.88 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1800 (n=54, 43, 42) | 7.60 Units on a Scale | Standard Error 1.25 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 360 (n=84, 66, 64) | 7.13 Units on a Scale | Standard Error 0.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 720 (n=73, 55, 53) | 8.48 Units on a Scale | Standard Error 1.25 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1080 (n=63, 50, 49) | 8.14 Units on a Scale | Standard Error 1.36 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1440 (n=59, 46, 44) | 9.53 Units on a Scale | Standard Error 1.28 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2160 (n=45, 36, 35) | 10.61 Units on a Scale | Standard Error 1.44 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2520 (n=38, 35, 33) | 8.26 Units on a Scale | Standard Error 1.58 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2880 (n=33, 30, 31) | 7.51 Units on a Scale | Standard Error 1.35 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 3060 (n=17, 17, 16) | 5.70 Units on a Scale | Standard Error 1.98 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1080 (n=63, 50, 49) | 9.28 Units on a Scale | Standard Error 1.29 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 360 (n=84, 66, 64) | 4.53 Units on a Scale | Standard Error 1.04 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2520 (n=38, 35, 33) | 7.92 Units on a Scale | Standard Error 1.8 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 720 (n=73, 55, 53) | 8.30 Units on a Scale | Standard Error 1.1 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 3060 (n=17, 17, 16) | 9.06 Units on a Scale | Standard Error 2.35 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1800 (n=54, 43, 42) | 9.18 Units on a Scale | Standard Error 1.2 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 1440 (n=59, 46, 44) | 9.50 Units on a Scale | Standard Error 1.29 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2880 (n=33, 30, 31) | 9.19 Units on a Scale | Standard Error 1.64 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period | Change from BL on Day 2160 (n=45, 36, 35) | 8.86 Units on a Scale | Standard Error 1.65 |
Secondary
Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 7.91 Units on a Scale | Standard Error 1.48 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 8.36 Units on a Scale | Standard Error 1.16 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 9.24 Units on a Scale | Standard Error 1.74 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 8.39 Units on a Scale | Standard Error 1.6 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 8.58 Units on a Scale | Standard Error 1.11 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 9.93 Units on a Scale | Standard Error 2.09 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 8.36 Units on a Scale | Standard Error 1.32 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 6.21 Units on a Scale | Standard Error 2.87 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 7.92 Units on a Scale | Standard Error 2.02 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 6.53 Units on a Scale | Standard Error 0.99 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 7.50 Units on a Scale | Standard Error 1.32 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 6.22 Units on a Scale | Standard Error 1.49 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 7.19 Units on a Scale | Standard Error 1.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 5.48 Units on a Scale | Standard Error 1.45 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 8.28 Units on a Scale | Standard Error 1.53 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 6.58 Units on a Scale | Standard Error 1.74 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 5.90 Units on a Scale | Standard Error 1.63 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 4.29 Units on a Scale | Standard Error 1.91 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 7.62 Units on a Scale | Standard Error 1.08 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 3.31 Units on a Scale | Standard Error 0.92 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 5.87 Units on a Scale | Standard Error 1.64 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 7.30 Units on a Scale | Standard Error 1.15 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 18, 16) | 6.16 Units on a Scale | Standard Error 2.01 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.16 Units on a Scale | Standard Error 1.33 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 7.58 Units on a Scale | Standard Error 1.22 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.63 Units on a Scale | Standard Error 1.49 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 5.46 Units on a Scale | Standard Error 1.32 |
Secondary
Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 6.67 Units on a Scale | Standard Error 1.86 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 9.92 Units on a Scale | Standard Error 4.09 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 7.84 Units on a Scale | Standard Error 2.16 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 7.41 Units on a Scale | Standard Error 2.04 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 64) | 8.03 Units on a Scale | Standard Error 1.58 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 8.94 Units on a Scale | Standard Error 2.72 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 5.76 Units on a Scale | Standard Error 1.88 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 6.93 Units on a Scale | Standard Error 1.68 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 5.82 Units on a Scale | Standard Error 2.34 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 4.16 Units on a Scale | Standard Error 2.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 64) | 7.55 Units on a Scale | Standard Error 2.05 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 8.28 Units on a Scale | Standard Error 2.29 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 4.64 Units on a Scale | Standard Error 2.24 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 8.24 Units on a Scale | Standard Error 2.31 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 7.61 Units on a Scale | Standard Error 2.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 8.43 Units on a Scale | Standard Error 2.92 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 8.78 Units on a Scale | Standard Error 2.32 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 5.85 Units on a Scale | Standard Error 3.92 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 7.95 Units on a Scale | Standard Error 2.27 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 64) | 3.79 Units on a Scale | Standard Error 1.94 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 5.75 Units on a Scale | Standard Error 2.64 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 6.36 Units on a Scale | Standard Error 1.97 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 0.66 Units on a Scale | Standard Error 4.66 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 4.51 Units on a Scale | Standard Error 2.19 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 7.18 Units on a Scale | Standard Error 2.56 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 4.76 Units on a Scale | Standard Error 3.04 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 6.47 Units on a Scale | Standard Error 2.87 |
Secondary
Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 7.78 Units on a Scale | Standard Error 1.69 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 11.65 Units on a Scale | Standard Error 3.53 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 10.37 Units on a Scale | Standard Error 1.86 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 9.95 Units on a Scale | Standard Error 1.85 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 66) | 10.10 Units on a Scale | Standard Error 1.32 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 11.79 Units on a Scale | Standard Error 2.32 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 8.73 Units on a Scale | Standard Error 1.63 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 9.69 Units on a Scale | Standard Error 1.51 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 9.49 Units on a Scale | Standard Error 2.2 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 7.57 Units on a Scale | Standard Error 1.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 66) | 6.97 Units on a Scale | Standard Error 1.22 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 9.60 Units on a Scale | Standard Error 1.49 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 8.06 Units on a Scale | Standard Error 1.69 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 10.30 Units on a Scale | Standard Error 1.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 10.41 Units on a Scale | Standard Error 1.92 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 9.50 Units on a Scale | Standard Error 1.94 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 7.31 Units on a Scale | Standard Error 1.84 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 4.32 Units on a Scale | Standard Error 2.63 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 12.12 Units on a Scale | Standard Error 1.86 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 66, 66) | 5.68 Units on a Scale | Standard Error 1.51 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 9.43 Units on a Scale | Standard Error 2.57 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 9.03 Units on a Scale | Standard Error 1.55 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 10.61 Units on a Scale | Standard Error 3.48 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 11.11 Units on a Scale | Standard Error 1.74 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 11.89 Units on a Scale | Standard Error 1.76 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 10.95 Units on a Scale | Standard Error 2.32 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 11.65 Units on a Scale | Standard Error 2.14 |
Secondary
Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 6.24 Units on a Scale | Standard Error 1.51 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 6.07 Units on a Scale | Standard Error 2.98 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 9.53 Units on a Scale | Standard Error 1.58 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 8.65 Units on a Scale | Standard Error 1.49 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 8.47 Units on a Scale | Standard Error 1.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 7.90 Units on a Scale | Standard Error 1.99 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 5.94 Units on a Scale | Standard Error 1.2 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 6.62 Units on a Scale | Standard Error 1.39 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 5.00 Units on a Scale | Standard Error 2.24 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.69 Units on a Scale | Standard Error 1.56 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 8.02 Units on a Scale | Standard Error 1.11 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 8.43 Units on a Scale | Standard Error 1.35 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 8.25 Units on a Scale | Standard Error 1.05 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 9.56 Units on a Scale | Standard Error 1.39 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 9.95 Units on a Scale | Standard Error 1.29 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 10.70 Units on a Scale | Standard Error 1.4 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.69 Units on a Scale | Standard Error 1.7 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 6.03 Units on a Scale | Standard Error 2.23 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=64, 50, 49) | 7.87 Units on a Scale | Standard Error 1.38 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 4.44 Units on a Scale | Standard Error 1.12 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 35, 33) | 5.76 Units on a Scale | Standard Error 2.19 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 6.86 Units on a Scale | Standard Error 1.28 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=17, 18, 16) | 4.07 Units on a Scale | Standard Error 3.03 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.59 Units on a Scale | Standard Error 1.86 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=60, 46, 44) | 8.02 Units on a Scale | Standard Error 1.82 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 5.25 Units on a Scale | Standard Error 1.93 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 36, 35) | 7.13 Units on a Scale | Standard Error 2.08 |
Secondary
Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 6.00 Units on a Scale | Standard Error 1.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 4.60 Units on a Scale | Standard Error 3.02 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 8.15 Units on a Scale | Standard Error 1.53 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 7.44 Units on a Scale | Standard Error 1.41 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 8.50 Units on a Scale | Standard Error 1.02 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 6.65 Units on a Scale | Standard Error 1.86 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 7.73 Units on a Scale | Standard Error 1.18 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 7.77 Units on a Scale | Standard Error 1.01 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.64 Units on a Scale | Standard Error 1.98 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 6.33 Units on a Scale | Standard Error 1.14 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 4.91 Units on a Scale | Standard Error 1.03 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 6.20 Units on a Scale | Standard Error 1.27 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 6.30 Units on a Scale | Standard Error 1.16 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 7.61 Units on a Scale | Standard Error 1.23 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 7.10 Units on a Scale | Standard Error 1.18 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 6.86 Units on a Scale | Standard Error 1.21 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 7.10 Units on a Scale | Standard Error 1.34 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 6.68 Units on a Scale | Standard Error 2.21 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1080 (n=63, 50, 49) | 6.46 Units on a Scale | Standard Error 1.23 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 1.86 Units on a Scale | Standard Error 1.04 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2520 (n=38, 36, 33) | 3.82 Units on a Scale | Standard Error 2.03 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 55, 53) | 4.69 Units on a Scale | Standard Error 1.2 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3060 (n=18, 17, 16) | 3.99 Units on a Scale | Standard Error 2.34 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1800 (n=54, 43, 42) | 3.49 Units on a Scale | Standard Error 1.7 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1440 (n=59, 46, 44) | 4.73 Units on a Scale | Standard Error 1.62 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2880 (n=33, 30, 31) | 4.76 Units on a Scale | Standard Error 1.7 |
| DB Placebo + Methotrexate | Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2160 (n=45, 37, 35) | 4.60 Units on a Scale | Standard Error 1.96 |
Secondary
Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period
Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1440 (n=56, 46, 41) | -1.56 mg/dL | Standard Error 0.33 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 3060 (n=14, 10, 8) | -1.06 mg/dL | Standard Error 0.36 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2160 (n=43, 34, 33) | -1.33 mg/dL | Standard Error 0.37 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1800 (n=52, 41, 41) | -1.53 mg/dL | Standard Error 0.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 360 (n=78, 65, 65) | -1.38 mg/dL | Standard Error 0.29 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2880 (n=27, 26, 27) | -1.47 mg/dL | Standard Error 0.34 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1080 (n=61, 50, 47) | -0.96 mg/dL | Standard Error 0.44 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 720 (n=68, 54, 53) | -1.46 mg/dL | Standard Error 0.25 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2520 (n=36, 35, 32) | -1.45 mg/dL | Standard Error 0.39 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1800 (n=52, 41, 41) | -1.33 mg/dL | Standard Error 0.83 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 360 (n=78, 65, 65) | -1.13 mg/dL | Standard Error 0.33 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 720 (n=68, 54, 53) | -2.08 mg/dL | Standard Error 0.38 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1080 (n=61, 50, 47) | -1.93 mg/dL | Standard Error 0.38 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1440 (n=56, 46, 41) | -1.91 mg/dL | Standard Error 0.37 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2160 (n=43, 34, 33) | -2.11 mg/dL | Standard Error 0.46 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2520 (n=36, 35, 32) | -2.29 mg/dL | Standard Error 0.48 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2880 (n=27, 26, 27) | -2.16 mg/dL | Standard Error 0.61 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 3060 (n=14, 10, 8) | -2.10 mg/dL | Standard Error 1 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1080 (n=61, 50, 47) | -1.20 mg/dL | Standard Error 0.35 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 360 (n=78, 65, 65) | -0.08 mg/dL | Standard Error 0.38 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2520 (n=36, 35, 32) | -2.01 mg/dL | Standard Error 0.4 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 720 (n=68, 54, 53) | -1.26 mg/dL | Standard Error 0.28 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 3060 (n=14, 10, 8) | -1.73 mg/dL | Standard Error 0.5 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1800 (n=52, 41, 41) | -1.72 mg/dL | Standard Error 0.35 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 1440 (n=56, 46, 41) | -1.21 mg/dL | Standard Error 0.44 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2880 (n=27, 26, 27) | -2.25 mg/dL | Standard Error 0.49 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period | Change at Day 2160 (n=43, 34, 33) | -2.04 mg/dL | Standard Error 0.42 |
Secondary
Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period
Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.
Time frame: Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1440 (n=57, 41, 41) | 43.81 IU/mL | Standard Error 97.15 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 3060 (n=7, 9, 5) | -45.14 IU/mL | Standard Error 88.72 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2160 (n=43, 34, 30) | -8.44 IU/mL | Standard Error 45.19 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1800 (n=51, 41, 40) | 30.29 IU/mL | Standard Error 30.78 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 360 (n=80, 62, 65) | -72.78 IU/mL | Standard Error 39.69 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2880 (n=15, 16, 13) | 28.47 IU/mL | Standard Error 45.91 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1080 (n=64, 49, 47) | 8.53 IU/mL | Standard Error 66.71 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 720 (n=69, 57, 54) | 37.51 IU/mL | Standard Error 76.03 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2520 (n=23, 24, 22) | 87.61 IU/mL | Standard Error 99.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1800 (n=51, 41, 40) | 10.95 IU/mL | Standard Error 41.17 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 360 (n=80, 62, 65) | -21.71 IU/mL | Standard Error 14.5 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 720 (n=69, 57, 54) | -40.23 IU/mL | Standard Error 23.05 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1080 (n=64, 49, 47) | -34.78 IU/mL | Standard Error 24.22 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1440 (n=57, 41, 41) | -15.68 IU/mL | Standard Error 32.26 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2160 (n=43, 34, 30) | -26.29 IU/mL | Standard Error 35.06 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2520 (n=23, 24, 22) | -54.92 IU/mL | Standard Error 41.93 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2880 (n=15, 16, 13) | -102.06 IU/mL | Standard Error 64.62 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 3060 (n=7, 9, 5) | -89.00 IU/mL | Standard Error 109.53 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1080 (n=64, 49, 47) | -0.04 IU/mL | Standard Error 38.15 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 360 (n=80, 62, 65) | 7.77 IU/mL | Standard Error 21.05 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2520 (n=23, 24, 22) | -50.05 IU/mL | Standard Error 70.38 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 720 (n=69, 57, 54) | -48.37 IU/mL | Standard Error 48.47 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 3060 (n=7, 9, 5) | 118.40 IU/mL | Standard Error 252.72 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1800 (n=51, 41, 40) | -49.83 IU/mL | Standard Error 40.58 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 1440 (n=57, 41, 41) | 1.54 IU/mL | Standard Error 49.24 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2880 (n=15, 16, 13) | 46.54 IU/mL | Standard Error 193.55 |
| DB Placebo + Methotrexate | Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period | Change at Day 2160 (n=43, 34, 30) | -65.50 IU/mL | Standard Error 51.49 |
Secondary
Mean Change From Baseline in sIL2-r Over Time in OL Period
Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Time frame: Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1440 (n=47, 36, 31) | -421.57 pg/mL | Standard Error 98.79 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 720 (n=66, 53, 49) | -323.26 pg/mL | Standard Error 83.71 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1800 (n=27, 13, 17) | -249.81 pg/mL | Standard Error 123.3 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 360 (n=69, 57, 58) | -200.62 pg/mL | Standard Error 56.43 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1080 (n=57, 47, 44) | -158.93 pg/mL | Standard Error 96.6 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 360 (n=69, 57, 58) | 44.05 pg/mL | Standard Error 60.8 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1440 (n=47, 36, 31) | -392.08 pg/mL | Standard Error 81.78 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1080 (n=57, 47, 44) | -44.98 pg/mL | Standard Error 95.04 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1800 (n=27, 13, 17) | -84.77 pg/mL | Standard Error 61.61 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 720 (n=66, 53, 49) | -209.19 pg/mL | Standard Error 60.08 |
| DB Placebo + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1800 (n=27, 13, 17) | -247.12 pg/mL | Standard Error 128.65 |
| DB Placebo + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 720 (n=66, 53, 49) | -213.22 pg/mL | Standard Error 83.64 |
| DB Placebo + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1080 (n=57, 47, 44) | -156.20 pg/mL | Standard Error 69.04 |
| DB Placebo + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 1440 (n=47, 36, 31) | -394.45 pg/mL | Standard Error 123.99 |
| DB Placebo + Methotrexate | Mean Change From Baseline in sIL2-r Over Time in OL Period | Change at Day 360 (n=69, 57, 58) | 207.40 pg/mL | Standard Error 91.17 |
Secondary
Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.
Time frame: BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,440 (n=60, 46, 44) | 9.54 Units on a Scale | Standard Error 1.37 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3,060 (n=17, 18, 16) | 9.28 Units on a Scale | Standard Error 3.77 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,160 (n=45, 36, 35) | 10.27 Units on a Scale | Standard Error 1.83 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,800 (n=54, 43, 42) | 9.08 Units on a Scale | Standard Error 1.5 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 10.35 Units on a Scale | Standard Error 1.14 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,880 (n=33, 30, 31) | 11.68 Units on a Scale | Standard Error 1.99 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,080 (n=64, 50, 49) | 9.02 Units on a Scale | Standard Error 1.35 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 8.84 Units on a Scale | Standard Error 1.36 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,520 (n=38, 35, 33) | 10.97 Units on a Scale | Standard Error 1.9 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,800 (n=54, 43, 42) | 8.73 Units on a Scale | Standard Error 1.62 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 9.26 Units on a Scale | Standard Error 1.07 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 9.40 Units on a Scale | Standard Error 1.33 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,080 (n=64, 50, 49) | 9.67 Units on a Scale | Standard Error 1.55 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,440 (n=60, 46, 44) | 11.38 Units on a Scale | Standard Error 1.59 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,160 (n=45, 36, 35) | 12.11 Units on a Scale | Standard Error 1.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,520 (n=38, 35, 33) | 10.55 Units on a Scale | Standard Error 1.61 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,880 (n=33, 30, 31) | 10.08 Units on a Scale | Standard Error 1.66 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3,060 (n=17, 18, 16) | 6.45 Units on a Scale | Standard Error 2.85 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,080 (n=64, 50, 49) | 9.48 Units on a Scale | Standard Error 1.59 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 360 (n=84, 67, 66) | 4.12 Units on a Scale | Standard Error 1.13 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,520 (n=38, 35, 33) | 10.11 Units on a Scale | Standard Error 1.76 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 720 (n=73, 56, 53) | 9.17 Units on a Scale | Standard Error 1.42 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 3,060 (n=17, 18, 16) | 10.52 Units on a Scale | Standard Error 3.15 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,800 (n=54, 43, 42) | 10.03 Units on a Scale | Standard Error 1.64 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 1,440 (n=60, 46, 44) | 10.86 Units on a Scale | Standard Error 1.61 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,880 (n=33, 30, 31) | 10.86 Units on a Scale | Standard Error 1.86 |
| DB Placebo + Methotrexate | Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period | Change from BL at Day 2,160 (n=45, 36, 35) | 10.83 Units on a Scale | Standard Error 1.74 |
Secondary
Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360
SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 180 (n=115, 104, 119) | 8.3 units on a scale | Standard Error 0.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | MCS, Mean Change at Day 180 (n=115, 104, 119) | 5.0 units on a scale | Standard Error 1 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 8.1 units on a scale | Standard Error 0.9 |
| DB Abatacept 10 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 5.7 units on a scale | Standard Error 1 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 3.5 units on a scale | Standard Error 1.1 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 180 (n=115, 104, 119) | 4.6 units on a scale | Standard Error 0.7 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 5.3 units on a scale | Standard Error 0.8 |
| DB Abatacept 2 mg/kg + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | MCS, Mean Change at Day 180 (n=115, 104, 119) | 2.7 units on a scale | Standard Error 1.2 |
| DB Placebo + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 3.0 units on a scale | Standard Error 0.9 |
| DB Placebo + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | MCS, Mean Change at Day 180 (n=115, 104, 119) | 3.2 units on a scale | Standard Error 1 |
| DB Placebo + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 360 (n=115, 104, 119) | 2.8 units on a scale | Standard Error 0.7 |
| DB Placebo + Methotrexate | Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360 | PCS, Mean Change at Day 180 (n=115, 104, 119) | 3.0 units on a scale | Standard Error 0.6 |
Secondary
Number of ACR 20 Responders in DB Period
ACR 20 response requires a participant 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, participant global assessment of disease, participant 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: Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360
Population: Participants who received at least 1 infusion of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 180 | 70 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 90 | 62 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 300 | 73 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 150 | 67 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 120 | 71 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 30 | 48 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 15 | 30 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 240 | 72 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 60 | 65 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 360 | 72 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 120 | 47 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 15 | 9 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 30 | 22 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 60 | 35 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 90 | 40 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 360 | 44 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 150 | 46 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 180 | 44 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 240 | 43 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in DB Period | Day 300 | 41 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 60 | 41 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 360 | 43 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 180 | 42 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 30 | 36 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 300 | 41 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 240 | 42 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 120 | 45 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 90 | 42 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 15 | 24 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in DB Period | Day 150 | 42 Participants |
Comparison: Response on Day 15p-value: 0.28395% CI: [-4.9, 16.7]Chi-squared
Comparison: Response on Day 15p-value: 0.01595% CI: [-20.9, -2.3]Chi-squared
Comparison: Response on Day 30p-value: 0.06795% CI: [-0.8, 23.8]Chi-squared
Comparison: Response on Day 30p-value: 0.11395% CI: [-20.8, 2.2]Chi-squared
Comparison: Response on Day 60p-value: <0.00195% CI: [9.3, 34.8]Chi-squared
Comparison: Response on Day 60p-value: 0.8695% CI: [-13.5, 11.3]Chi-squared
Comparison: Response on Day 90p-value: 0.00495% CI: [5.9, 31.4]Chi-squared
Comparison: Response on Day 90p-value: 0.66495% CI: [-9.8, 15.4]Chi-squared
Comparison: Response on Day 120p-value: <0.00195% CI: [11.1, 36.7]Chi-squared
Comparison: Response on Day 120p-value: 0.29295% CI: [-6, 19.9]Chi-squared
Comparison: Response on Day 150p-value: <0.00195% CI: [10.2, 35.8]Chi-squared
Comparison: Response on Day 150p-value: 0.19395% CI: [-4.3, 21.3]Chi-squared
Comparison: Response on Day 180p-value: <0.00195% CI: [12.8, 38.4]Chi-squared
Comparison: Response on Day 180p-value: 0.3195% CI: [-6.2, 19.4]Chi-squared
Comparison: Response on Day 240p-value: <0.00195% CI: [14.5, 40.1]Chi-squared
Comparison: Response on Day 240p-value: 0.38495% CI: [-7.1, 18.4]Chi-squared
Comparison: Response on Day 300p-value: <0.00195% CI: [16.2, 41.8]Chi-squared
Comparison: Response on Day 300p-value: 0.47695% CI: [-8, 17.2]Chi-squared
Comparison: Response on Day 360p-value: <0.00195% CI: [13.7, 39.3]Chi-squared
Comparison: Response on Day 360p-value: 0.37795% CI: [-7, 18.6]Chi-squared
Secondary
Number of ACR 20 Responders in OL Period
ACR 20 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire 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: Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 900 (n=69, 53, 51) | 56 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 360 (n=84, 68, 67) | 64 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 450 (n=83, 67, 66) | 56 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 540 (n=82, 65, 59) | 61 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 720 (n=75, 59, 56) | 58 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 810 (n=73, 56, 54) | 49 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 630 (n=79, 63, 59) | 60 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 990 (n=66, 52, 51) | 52 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1080 (n=66, 50, 49) | 48 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1170 (n=65, 50, 49) | 46 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1260 (n=64, 49, 46) | 48 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1350 (n=62, 48, 44) | 46 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 440 (n=61, 47, 44) | 43 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1530 (n=60, 46, 43) | 45 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1620 (n=58, 45, 43) | 44 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1710 (n=58, 45, 42) | 37 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1800 (n=56, 44, 42) | 44 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1980 (n=53, 44, 40) | 37 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2160 (n=49, 42, 38) | 39 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2340 (n=47, 36, 36) | 35 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2520 (n=43, 37, 33) | 31 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2700 (n=37, 34, 34) | 33 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2880 (n=36, 31, 32) | 28 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 3060 (n=18, 18, 17) | 13 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2700 (n=37, 34, 34) | 26 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 540 (n=82, 65, 59) | 45 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 440 (n=61, 47, 44) | 38 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1800 (n=56, 44, 42) | 32 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 360 (n=84, 68, 67) | 40 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1260 (n=64, 49, 46) | 41 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2520 (n=43, 37, 33) | 30 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 450 (n=83, 67, 66) | 45 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1530 (n=60, 46, 43) | 35 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2880 (n=36, 31, 32) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 630 (n=79, 63, 59) | 44 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1170 (n=65, 50, 49) | 35 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1980 (n=53, 44, 40) | 34 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 720 (n=75, 59, 56) | 39 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1620 (n=58, 45, 43) | 35 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1350 (n=62, 48, 44) | 30 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 810 (n=73, 56, 54) | 41 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1080 (n=66, 50, 49) | 39 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 3060 (n=18, 18, 17) | 13 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 900 (n=69, 53, 51) | 42 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1710 (n=58, 45, 42) | 34 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2160 (n=49, 42, 38) | 33 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 990 (n=66, 52, 51) | 39 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2340 (n=47, 36, 36) | 27 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 990 (n=66, 52, 51) | 40 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1080 (n=66, 50, 49) | 35 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1170 (n=65, 50, 49) | 36 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1260 (n=64, 49, 46) | 39 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2340 (n=47, 36, 36) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1350 (n=62, 48, 44) | 37 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2880 (n=36, 31, 32) | 27 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 440 (n=61, 47, 44) | 37 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1530 (n=60, 46, 43) | 29 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2520 (n=43, 37, 33) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1620 (n=58, 45, 43) | 38 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 3060 (n=18, 18, 17) | 14 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1710 (n=58, 45, 42) | 38 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 540 (n=82, 65, 59) | 45 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 360 (n=84, 68, 67) | 37 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1800 (n=56, 44, 42) | 38 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 450 (n=83, 67, 66) | 46 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2700 (n=37, 34, 34) | 23 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 630 (n=79, 63, 59) | 44 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 720 (n=75, 59, 56) | 43 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 1980 (n=53, 44, 40) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 810 (n=73, 56, 54) | 44 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 900 (n=69, 53, 51) | 42 Participants |
| DB Placebo + Methotrexate | Number of ACR 20 Responders in OL Period | Day 2160 (n=49, 42, 38) | 32 Participants |
Secondary
Number of ACR 50 Responders in DB Period
ACR 50 response requires a participant 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, participant global assessment of disease, participant 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 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Population: Participants who received at least 1 infusion of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 15 | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 30 | 16 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 60 | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 90 | 28 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 120 | 38 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 150 | 42 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 180 | 42 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 240 | 41 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 300 | 45 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 360 | 48 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 300 | 23 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 15 | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 150 | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 120 | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 30 | 4 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 360 | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 240 | 22 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 60 | 14 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 180 | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in DB Period | Day 90 | 18 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 240 | 24 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 90 | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 120 | 18 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 150 | 19 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 300 | 18 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 180 | 14 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 15 | 3 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 360 | 24 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 30 | 7 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in DB Period | Day 60 | 18 Participants |
Comparison: Response on Day 15p-value: 0.67995% CI: [-4.5, 2.9]Chi-squared
Comparison: Response on Day 15p-value: 0.10195% CI: [-5.5, 0.5]Chi-squared
Comparison: Response on Day 30p-value: 0.03995% CI: [0.4, 15.7]Chi-squared
Comparison: Response on Day 30p-value: 0.47495% CI: [-7.7, 3.6]Chi-squared
Comparison: Response on Day 60p-value: 0.19295% CI: [-3.3, 16.5]Chi-squared
Comparison: Response on Day 60p-value: 0.70295% CI: [-11, 7.4]Chi-squared
Comparison: Response on Day 90p-value: 0.0295% CI: [1.8, 21.7]Chi-squared
Comparison: Response on Day 90p-value: 0.33995% CI: [-4.8, 13.8]Chi-squared
Comparison: Response on Day 120p-value: 0.00195% CI: [7, 28.9]Chi-squared
Comparison: Response on Day 120p-value: 0.68295% CI: [-7.6, 11.7]Chi-squared
Comparison: Response on Day 150p-value: <0.00195% CI: [9.3, 31.8]Chi-squared
Comparison: Response on Day 150p-value: 0.81395% CI: [-8.6, 10.9]Chi-squared
Comparison: Response on Day 180p-value: <0.00195% CI: [13.8, 35.7]Chi-squared
Comparison: Response on Day 180p-value: 0.02795% CI: [1.2, 20.9]Chi-squared
Comparison: Response on Day 240p-value: 0.00895% CI: [4, 27]Chi-squared
Comparison: Response on Day 240p-value: 0.88595% CI: [-9.8, 11.4]Chi-squared
Comparison: Response on Day 300p-value: <0.00195% CI: [12.6, 35.4]Chi-squared
Comparison: Response on Day 300p-value: 0.1995% CI: [-3.4, 16.9]Chi-squared
Comparison: Response on Day 360p-value: <0.00195% CI: [9.7, 33.4]Chi-squared
Comparison: Response on Day 360p-value: 0.62595% CI: [-8.1, 13.5]Chi-squared
Secondary
Number of ACR 50 Responders in the OL Period
ACR 50 response requires a participant 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, participant global assessment of disease, participant 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: Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 900 (n=69, 53, 51) | 40 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 450 (n=83, 67, 66) | 41 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 540 (n=82, 65, 59) | 38 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 630 (n=79, 63, 59) | 38 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 720 (n=75, 59, 56) | 43 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 810 (n=73, 56, 54) | 42 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 360 (n=84, 68, 67) | 44 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 990 (n=66, 52, 51) | 40 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,080 (n=66, 50, 49) | 35 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,170 (n=65, 50, 49) | 36 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,260 (n=64, 49, 46) | 33 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,350 (n=62, 48, 44) | 28 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,440 (n=61, 47, 44) | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,530 (n=60, 46, 43) | 33 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,620 (n=58, 45, 43) | 29 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,710 (n=58, 45, 42) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,800 (n=56, 44, 42) | 34 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,980 (n=53, 44, 40) | 31 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,160 (n=49, 42, 38) | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,340 (n=47, 36, 36) | 24 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,520 (n=43, 37, 33) | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,700 (n=37, 34, 34) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,880 (n=36, 31, 32) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 3,060 (n=18, 18, 17) | 8 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,700 (n=37, 34, 34) | 19 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 360 (n=84, 68, 67) | 23 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,440 (n=61, 47, 44) | 33 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,800 (n=56, 44, 42) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 450 (n=83, 67, 66) | 30 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,260 (n=64, 49, 46) | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,520 (n=43, 37, 33) | 23 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 540 (n=82, 65, 59) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,530 (n=60, 46, 43) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,880 (n=36, 31, 32) | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 630 (n=79, 63, 59) | 27 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,170 (n=65, 50, 49) | 27 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,980 (n=53, 44, 40) | 26 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 720 (n=75, 59, 56) | 29 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,620 (n=58, 45, 43) | 27 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,350 (n=62, 48, 44) | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 810 (n=73, 56, 54) | 23 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,080 (n=66, 50, 49) | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 3,060 (n=18, 18, 17) | 10 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 900 (n=69, 53, 51) | 34 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,710 (n=58, 45, 42) | 27 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,160 (n=49, 42, 38) | 30 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 990 (n=66, 52, 51) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,340 (n=47, 36, 36) | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 990 (n=66, 52, 51) | 31 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,080 (n=66, 50, 49) | 29 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,170 (n=65, 50, 49) | 29 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,260 (n=64, 49, 46) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,340 (n=47, 36, 36) | 21 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,350 (n=62, 48, 44) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,880 (n=36, 31, 32) | 19 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,440 (n=61, 47, 44) | 24 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,530 (n=60, 46, 43) | 26 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,520 (n=43, 37, 33) | 21 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,620 (n=58, 45, 43) | 26 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 3,060 (n=18, 18, 17) | 9 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,710 (n=58, 45, 42) | 25 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 360 (n=84, 68, 67) | 21 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 450 (n=83, 67, 66) | 30 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,800 (n=56, 44, 42) | 28 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 540 (n=82, 65, 59) | 31 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,700 (n=37, 34, 34) | 17 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 630 (n=79, 63, 59) | 31 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 720 (n=75, 59, 56) | 34 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 1,980 (n=53, 44, 40) | 22 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 810 (n=73, 56, 54) | 30 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 900 (n=69, 53, 51) | 29 Participants |
| DB Placebo + Methotrexate | Number of ACR 50 Responders in the OL Period | Day 2,160 (n=49, 42, 38) | 25 Participants |
Secondary
Number of ACR 70 Responders in DB Period
ACR 70 response requires a participant 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, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, 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 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Population: Participants who received at least 1 infusion of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 15 | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 30 | 4 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 60 | 10 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 90 | 10 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 120 | 15 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 150 | 16 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 180 | 19 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 240 | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 300 | 27 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 360 | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 300 | 11 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 15 | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 150 | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 120 | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 30 | 3 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 360 | 13 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 240 | 9 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 60 | 4 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 180 | 11 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in DB Period | Day 90 | 5 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 240 | 6 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 90 | 1 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 120 | 4 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 150 | 4 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 300 | 3 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 180 | 2 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 15 | 0 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 360 | 9 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 30 | 0 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in DB Period | Day 60 | 0 Participants |
Comparison: Response on Day 30p-value: 0.0495% CI: [0.2, 6.8]Chi-squared
Comparison: Response on Day 30p-value: 0.06395% CI: [-0.2, 5.9]Chi-squared
Comparison: Response on Day 60p-value: 0.00195% CI: [3.5, 13.9]Chi-squared
Comparison: Response on Day 60p-value: 0.03295% CI: [0.3, 7.3]Chi-squared
Comparison: Response on Day 90p-value: 0.00595% CI: [2.4, 13.3]Chi-squared
Comparison: Response on Day 90p-value: 0.0795% CI: [-0.3, 8.2]Chi-squared
Comparison: Response on Day 120p-value: 0.00795% CI: [2.7, 16.7]Chi-squared
p-value: 0.39595% CI: [-3.1, 7.8]Chi-squared
Comparison: Response on Day 150p-value: 0.00495% CI: [3.4, 17.7]Chi-squared
Comparison: Response on Day 150p-value: 0.39595% CI: [-3.1, 7.8]Chi-squared
Comparison: Response on Day 180p-value: <0.00195% CI: [7.5, 22.2]Chi-squared
Comparison: Response on Day 180p-value: 0.00595% CI: [2.7, 14.9]Chi-squared
Comparison: Response on Day 240p-value: 0.00295% CI: [5, 21.4]Chi-squared
Comparison: Response on Day 240p-value: 0.29295% CI: [-3, 10.1]Chi-squared
Comparison: Response on Day 300p-value: <0.00195% CI: [12.4, 29.5]Chi-squared
Comparison: Response on Day 300p-value: 0.01495% CI: [1.6, 14.3]Chi-squared
Comparison: Response on Day 360p-value: 0.00395% CI: [4.4, 22.2]Chi-squared
Comparison: Response on Day 360p-value: 0.22795% CI: [-3, 12.6]Chi-squared
Secondary
Number of ACR 70 Responders in the OL Period
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, 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: Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 900 (n=69, 53, 51) | 19 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 450 (n=83, 67, 66) | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 540 (n=82, 65, 59) | 28 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 630 (n=79, 63, 59) | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 720 (n=75, 59, 56) | 22 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 810 (n=73, 56, 54) | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 360 (n=84, 68, 67) | 24 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 990 (n=66, 52, 51) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1080 (n=66, 50, 49) | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1170 (n=65, 50, 49) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1260 (n=64, 49, 46) | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1350 (n=62, 48, 44) | 18 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1440 (n=61, 47, 44) | 19 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1530 (n=60, 46, 43) | 22 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1620 (n=58, 45, 43) | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1710 (n=58, 45, 42) | 15 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1800 (n=56, 44, 42) | 21 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1980 (n=53, 44, 40) | 25 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2160 (n=49, 42, 38) | 23 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2340 (n=47, 36, 36) | 19 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2520 (n=43, 37, 33) | 19 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2700 (n=37, 34, 34) | 20 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2880 (n=36, 31, 32) | 17 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 3060 (n=18, 18, 17) | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2700 (n=37, 34, 34) | 12 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 360 (n=84, 68, 67) | 13 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1440 (n=61, 47, 44) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1800 (n=56, 44, 42) | 17 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 450 (n=83, 67, 66) | 14 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1260 (n=64, 49, 46) | 12 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2520 (n=43, 37, 33) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 540 (n=82, 65, 59) | 15 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1530 (n=60, 46, 43) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2880 (n=36, 31, 32) | 10 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 630 (n=79, 63, 59) | 17 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1170 (n=65, 50, 49) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1980 (n=53, 44, 40) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 720 (n=75, 59, 56) | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1620 (n=58, 45, 43) | 15 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1350 (n=62, 48, 44) | 13 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 810 (n=73, 56, 54) | 14 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1080 (n=66, 50, 49) | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 3060 (n=18, 18, 17) | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 900 (n=69, 53, 51) | 16 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1710 (n=58, 45, 42) | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2160 (n=49, 42, 38) | 18 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 990 (n=66, 52, 51) | 17 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2340 (n=47, 36, 36) | 11 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 990 (n=66, 52, 51) | 17 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1080 (n=66, 50, 49) | 16 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1170 (n=65, 50, 49) | 17 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1260 (n=64, 49, 46) | 20 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2340 (n=47, 36, 36) | 14 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1350 (n=62, 48, 44) | 13 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2880 (n=36, 31, 32) | 12 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1440 (n=61, 47, 44) | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1530 (n=60, 46, 43) | 13 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2520 (n=43, 37, 33) | 11 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1620 (n=58, 45, 43) | 16 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 3060 (n=18, 18, 17) | 7 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1710 (n=58, 45, 42) | 12 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 360 (n=84, 68, 67) | 9 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 450 (n=83, 67, 66) | 12 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1800 (n=56, 44, 42) | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 540 (n=82, 65, 59) | 12 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2700 (n=37, 34, 34) | 12 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 630 (n=79, 63, 59) | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 720 (n=75, 59, 56) | 16 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 1980 (n=53, 44, 40) | 10 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 810 (n=73, 56, 54) | 11 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 900 (n=69, 53, 51) | 15 Participants |
| DB Placebo + Methotrexate | Number of ACR 70 Responders in the OL Period | Day 2160 (n=49, 42, 38) | 11 Participants |
Secondary
Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods
Time frame: Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)
Population: Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | 12 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | 16 participants |
| DB Placebo + Methotrexate | Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | 28 participants |
| Open-Label (OL) Abatacept (10 mg / kg) | Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | 26 participants |
Secondary
Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period
The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.
Time frame: Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Population: All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1440 (n=61, 47, 44) | 31 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 3060 (n=18, 18, 17) | 8 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2160 (n=49, 42, 38) | 26 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1800 (n=56, 44, 42) | 29 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 360 (n=84, 68, 67) | 46 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2880 (n=36, 31, 32) | 18 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1080 (n=66, 50, 49) | 34 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 720 (n=75, 59, 56) | 39 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2520 (n=43, 37, 33) | 23 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1800 (n=56, 44, 42) | 27 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 360 (n=84, 68, 67) | 30 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 720 (n=75, 59, 56) | 34 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1080 (n=66, 50, 49) | 28 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1440 (n=61, 47, 44) | 26 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2160 (n=49, 42, 38) | 24 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2520 (n=43, 37, 33) | 21 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2880 (n=36, 31, 32) | 21 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 3060 (n=18, 18, 17) | 8 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1080 (n=66, 50, 49) | 28 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 360 (n=84, 68, 67) | 23 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2520 (n=43, 37, 33) | 17 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 720 (n=75, 59, 56) | 21 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 3060 (n=18, 18, 17) | 5 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1800 (n=56, 44, 42) | 20 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 1440 (n=61, 47, 44) | 20 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2880 (n=36, 31, 32) | 14 Participants |
| DB Placebo + Methotrexate | Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period | Day 2160 (n=49, 42, 38) | 15 Participants |
Secondary
Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360
Time frame: Day 180, Day 360
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 180 | 47 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 360 | 33 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 360 | 45 participants |
| DB Abatacept 10 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 180 | 55 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 180 | 65 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 180 | 59 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 360 | 62 participants |
| DB Abatacept 2 mg/kg + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 360 | 59 participants |
| DB Placebo + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 360 | 69 participants |
| DB Placebo + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Tender Joints(s) at Day 180 | 70 participants |
| DB Placebo + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 180 | 75 participants |
| DB Placebo + Methotrexate | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | New Swollen Joints(s) at Day 360 | 69 participants |
Secondary
Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.
Time frame: From the start of study through the end of the double-blind period (at 12 months)
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related SAEs | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related AEs | 56 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Deaths | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | SAEs | 14 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to SAEs | 3 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to AEs | 6 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | AEs | 104 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to SAEs | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | AEs | 104 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related AEs | 50 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | SAEs | 19 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to AEs | 10 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Deaths | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related SAEs | 5 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Deaths | 0 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | SAEs | 19 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | AEs | 112 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to SAEs | 3 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related SAEs | 2 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Related AEs | 58 Participants |
| DB Placebo + Methotrexate | Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period | Discontinuations due to AEs | 11 Participants |
Secondary
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy
Time frame: From the start of study up to 60 days post the end of the 12-month double-blind period
Population: Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | Low Potassium | 2 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Potassium | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Aspartate Aminotransferase (AST) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Creatinine | 4 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Alanine Aminotransferase (ALT) | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Aspartate Aminotransferase (AST) | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | Low Potassium | 3 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Alanine Aminotransferase (ALT) | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Potassium | 3 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Creatinine | 3 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Potassium | 4 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Alanine Aminotransferase (ALT) | 2 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Aspartate Aminotransferase (AST) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | High Creatinine | 4 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | Low Potassium | 1 Participants |
Secondary
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy
Time frame: From the start of study up to 60 days post the end of the 12-month double-blind period
Population: Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Hemoglobin (n=115, 104, 119) | 1 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Platelets (n=114, 104, 119) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Platelets (n=114, 104, 119) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Leukocytes (n=115, 104, 119) | 0 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Leukocytes (n=115, 104, 119) | 12 Participants |
| DB Abatacept 10 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Neutrophils (n=115, 105, 119) | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Neutrophils (n=115, 105, 119) | 1 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Hemoglobin (n=115, 104, 119) | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Leukocytes (n=115, 104, 119) | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Leukocytes (n=115, 104, 119) | 6 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Platelets (n=114, 104, 119) | 0 Participants |
| DB Abatacept 2 mg/kg + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Platelets (n=114, 104, 119) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Platelets (n=114, 104, 119) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Platelets (n=114, 104, 119) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Neutrophils (n=115, 105, 119) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Leukocytes (n=115, 104, 119) | 0 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | Low Hemoglobin (n=115, 104, 119) | 3 Participants |
| DB Placebo + Methotrexate | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | High Leukocytes (n=115, 104, 119) | 14 Participants |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 180 (n=88, 80, 71) | -8.3 ng/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 360 (n=75, 67, 61) | -10.9 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 180 (n=88, 80, 71) | 0.5 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 360 (n=75, 67, 61) | 0.6 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 180 (n=88, 80, 71) | -0.7 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | Mean Change at Day 360 (n=75, 67, 61) | 2.0 ng/mL |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 180 (n=85, 74, 68) | -20.5 pg/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 360 (n=56, 47, 47) | -20.9 pg/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 180 (n=85, 74, 68) | -16.1 pg/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 360 (n=56, 47, 47) | -12.7 pg/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 180 (n=85, 74, 68) | 1.3 pg/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | Mean Change at Day 360 (n=56, 47, 47) | -0.6 pg/mL |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 84, 76) | -315.9 pg/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 360 (n=68, 55, 54) | -194.3 pg/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 84, 76) | -135.5 pg/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 360 (n=68, 55, 54) | 40.4 pg/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 84, 76) | 43.6 pg/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | Mean Change at Day 360 (n=68, 55, 54) | 196.8 pg/mL |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 180 (n=95, 84, 74) | -104.3 IU/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 360 (n=69, 54, 57) | -118.3 IU/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 180 (n=95, 84, 74) | -28.1 IU/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 360 (n=69, 54, 57) | -23.6 IU/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 180 (n=95, 84, 74) | -0.6 IU/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | Mean Change at Day 360 (n=69, 54, 57) | 20.9 IU/mL |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 82, 75) | -40.6 ng/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 360 (n=77, 67, 63) | -55.2 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 82, 75) | -6.2 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 360 (n=77, 67, 63) | -13.6 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 180 (n=94, 82, 75) | 1.1 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | Mean Change at Day 360 (n=77, 67, 63) | 0.7 ng/mL |
Secondary
Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360
Time frame: Baseline, Day 180, Day 360
Population: Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 180 (n=83, 74, 68) | -3.7 ng/mL |
| DB Abatacept 10 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 360 (n=61, 48, 49) | -3.0 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 180 (n=83, 74, 68) | -1.2 ng/mL |
| DB Abatacept 2 mg/kg + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 360 (n=61, 48, 49) | 1.1 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 180 (n=83, 74, 68) | -3.6 ng/mL |
| DB Placebo + Methotrexate | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | Mean Change at Day 360 (n=61, 48, 49) | -0.3 ng/mL |