Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.
Interventions
DRUGAbatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participants who completed the 169 days, full study period of Phase II (IM101-071) and were not administered other biologics between completion of IM101-071 and registration of this long-term study. * The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept. * New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).
Exclusion criteria
* Women of childbearing potential (WOCBP) who were unwilling or unable to use an acceptable method of contraception. * Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration. * Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest). * Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns. * The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin \< 8.5 g/dL, white blood cells (WBC) \< 3,000/mm\^3, Platelets \< 100,000/mm\^3, Serum creatinine \> 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase \> 2 times ULN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included. |
| Number of Participants With Abnormal Laboratory Changes (ALC) | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). | The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations. |
| Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | At BL (week 0), week 24, 48, 96, 144, and 192. | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of \> 5.1), low disease activity (change of ≤ 3.2) and remission (\< 2.6). Please see outcome 8 for change from BL data. |
| Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | At BL (week 0), weeks 24, 48, 96, 144, and 192. | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Please refer to outcome 7 for BL and PBL values. |
| Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | At BL (week 0), weeks 24, 48, 96, 144, and 192. | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement. |
| Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | At weeks 24, 48, 96, 144, and 192. | The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity. |
| Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | At weeks 24, 48, 96, 144, and 192. | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score \< 2.6 were considered to be in remission. |
| Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | At BL (week 0), weeks 24, 48, 96, 144, and 192. | The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ. |
| Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | At BL (week 0), weeks 24, 48, 96, 144, and 192. | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data. |
| Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | At baseline (week 0), weeks 24, 48, 96, 144, and 192. | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \>3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values. |
| Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | At BL (week 0), weeks 24, 48, 96, 144, and 192. | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data. |
| Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. | 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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
| Baseline and Postbaseline C-reactive Protein (CRP) Levels | At BL (week 0), weeks 24, 48, 96, 144, and 192. | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data. |
| Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | At BL (week 0), weeks 24, 48, 96, 144, and 192. | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value \* 100. Please refer to outcome 17 for BL and PBL values. |
| Baseline and Postbaseline Rheumatoid Factor Levels | At BL (week 0), weeks 24, 48, 96, 144, and 192. | Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please see outcome 20 for change from BL data. |
| Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | At BL (week 0), weeks 24, 48, 96, 144, and 192. | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please refer to outcome 19 for BL and PBL values. |
| Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192. | Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. |
| Abatacept PK Parameter: Total Body Clearance | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. | Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. |
| Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. | Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule. |
| Abatacept PK Parameter: Maximum Serum Concentration at Steady State | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. | Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max). |
| Abatacept PK Parameter: Minimum Plasma Concentration at Steady State | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state. |
| Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | At BL (Week 0), weeks 24, 48, 96, 144, and 192. | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values. |
| Percentage of Participants With ACR 50 Response Over Time | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. | 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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
| Percentage of Participants With ACR 70 Response Over Time | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. | 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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | 13 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | 178 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | 26 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Long Term Phase | Adverse Event | 1 | 17 | 5 |
| Long Term Phase | Inadequate response | 2 | 7 | 4 |
| Long Term Phase | Other Reason | 0 | 5 | 1 |
| Long Term Phase | Withdrawal by Subject | 0 | 7 | 6 |
| Post Marketing Phase | Adverse Event | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | New Participants With MTX Intolerance; Abatacept 10 mg/kg |
|---|---|---|---|---|
| Age Continuous | 53.8 years STANDARD_DEVIATION 11.4 | 52.8 years STANDARD_DEVIATION 11.6 | 53.2 years STANDARD_DEVIATION 11.5 | 57.8 years STANDARD_DEVIATION 10.6 |
| Age, Customized 20 - 29 years | 8 participants | 1 participants | 7 participants | 0 participants |
| Age, Customized 30 - 39 years | 16 participants | 2 participants | 13 participants | 1 participants |
| Age, Customized 40 - 49 years | 44 participants | 0 participants | 39 participants | 5 participants |
| Age, Customized 50 - 59 years | 83 participants | 6 participants | 70 participants | 7 participants |
| Age, Customized ≥ 60 years | 66 participants | 4 participants | 49 participants | 13 participants |
| American College of Rheumatology (ACR) Functional Status Classification Class I | 29 participants | 0 participants | 29 participants | 0 participants |
| American College of Rheumatology (ACR) Functional Status Classification Class II | 141 participants | 12 participants | 112 participants | 17 participants |
| American College of Rheumatology (ACR) Functional Status Classification Class III | 47 participants | 1 participants | 37 participants | 9 participants |
| American College of Rheumatology (ACR) Functional Status Classification Class IV | 0 participants | 0 participants | 0 participants | 0 participants |
| C-Reactive Protein (CRP) Level | 2.57 mg/dL STANDARD_DEVIATION 2.55 | 1.84 mg/dL STANDARD_DEVIATION 2.84 | 2.32 mg/dL STANDARD_DEVIATION 2.18 | 4.67 mg/dL STANDARD_DEVIATION 3.65 |
| Duration of Rheumatoid Arthritis > 10 years | 69 participants | 9 participants | 52 participants | 8 participants |
| Duration of Rheumatoid Arthritis >2 to <= 5 years | 51 participants | 2 participants | 45 participants | 4 participants |
| Duration of Rheumatoid Arthritis <= 2 years | 26 participants 7.9 | 0 participants 9 | 24 participants 7.3 | 2 participants 10.1 |
| Duration of Rheumatoid Arthritis > 5 to <= 10 years | 71 participants | 2 participants | 57 participants | 12 participants |
| Methotrexate Usage at Registration | 7.11 mg/week STANDARD_DEVIATION 1.09 | 7.11 mg/week STANDARD_DEVIATION 1.45 | 7.11 mg/week STANDARD_DEVIATION 1.07 | NA mg/week |
| Morning stiffness | 86.7 minutes STANDARD_DEVIATION 143 | 117.7 minutes STANDARD_DEVIATION 201.3 | 72.7 minutes STANDARD_DEVIATION 124.9 | 166.6 minutes STANDARD_DEVIATION 195.7 |
| Number of Swollen Joints | 12.1 joints STANDARD_DEVIATION 8.9 | 9.1 joints STANDARD_DEVIATION 4.7 | 11.6 joints STANDARD_DEVIATION 8.7 | 17.2 joints STANDARD_DEVIATION 10 |
| Number of Tender Joints | 14.9 joints STANDARD_DEVIATION 11.6 | 8.4 joints STANDARD_DEVIATION 5.2 | 14.3 joints STANDARD_DEVIATION 11.2 | 22.7 joints STANDARD_DEVIATION 13.3 |
| Oral Corticosteroids Usage at Registration | 5.85 mg/day STANDARD_DEVIATION 2.41 | 6.15 mg/day STANDARD_DEVIATION 2.37 | 5.67 mg/day STANDARD_DEVIATION 2.38 | 6.78 mg/day STANDARD_DEVIATION 2.48 |
| Participant Global Assessment | 53.7 units on a scale STANDARD_DEVIATION 24.8 | 47.1 units on a scale STANDARD_DEVIATION 20.7 | 50.8 units on a scale STANDARD_DEVIATION 23.8 | 77.3 units on a scale STANDARD_DEVIATION 20.4 |
| Participant Pain Assessment | 55.1 units on a scale STANDARD_DEVIATION 26 | 43.1 units on a scale STANDARD_DEVIATION 23.5 | 52.3 units on a scale STANDARD_DEVIATION 24.9 | 80.6 units on a scale STANDARD_DEVIATION 20.1 |
| Physical Function (Health Assessment Questionnaire [HAQ]) | 1.22 units on a scale STANDARD_DEVIATION 0.79 | 0.98 units on a scale STANDARD_DEVIATION 0.57 | 1.16 units on a scale STANDARD_DEVIATION 0.75 | 1.80 units on a scale STANDARD_DEVIATION 0.9 |
| Physician Global Assessment | 51.4 Units on a scale STANDARD_DEVIATION 24.9 | 56.5 Units on a scale STANDARD_DEVIATION 24.7 | 47.5 Units on a scale STANDARD_DEVIATION 24 | 75.5 Units on a scale STANDARD_DEVIATION 16.5 |
| Rheumatoid Factor Status Negative (<=20 IU/mL) | 29 participants | 1 participants | 24 participants | 4 participants |
| Rheumatoid Factor Status Positive (>20 IU/mL) | 188 participants | 12 participants | 154 participants | 22 participants |
| Sex: Female, Male Female | 177 Participants | 12 Participants | 146 Participants | 19 Participants |
| Sex: Female, Male Male | 40 Participants | 1 Participants | 32 Participants | 7 Participants |
| Weight | 56.5 kg STANDARD_DEVIATION 9.6 | 55.2 kg STANDARD_DEVIATION 9.7 | 56.9 kg STANDARD_DEVIATION 9.4 | 53.9 kg STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 176 / 178 | 24 / 26 |
| serious Total, serious adverse events | 4 / 13 | 50 / 178 | 14 / 26 |
Outcome results
Primary
Number of Participants With Abnormal Laboratory Changes (ALC)
The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.
Time frame: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Population: All treated participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with Serious ALC | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due Serious ALC | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with drug related Serious ALC | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with ALC | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 7 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 6 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 102 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with Serious ALC | 0 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with ALC | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 125 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due Serious ALC | 0 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with drug related Serious ALC | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due Serious ALC | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with drug related Serious ALC | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 13 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with ALC | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Participants with Serious ALC | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Abnormal Laboratory Changes (ALC) | Discontinuations due ALC | 19 participants |
Primary
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.
Time frame: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Population: All treated participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to SAEs | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related SAEs | 2 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Deaths | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to AEs | 1 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | AEs | 13 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | SAEs | 4 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related AEs | 13 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related AEs | 165 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to SAEs | 14 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to AEs | 18 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related SAEs | 26 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | AEs | 176 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Deaths | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | SAEs | 50 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Deaths | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | SAEs | 14 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related SAEs | 9 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | AEs | 24 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Drug-related AEs | 24 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to SAEs | 5 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | Discontinuation due to AEs | 5 participants |
Primary
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Time frame: At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Population: All treated participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight increased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic decreased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram abnormal | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature decreased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure decreased | 1 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic increased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature increased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST-T segment abnormal | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic decreased | 1 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic increased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate decreased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure increased | 2 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight decreased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate increased | 0 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST segment depression | 0 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST segment depression | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure increased | 27 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure decreased | 11 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic decreased | 7 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic increased | 3 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight decreased | 5 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight increased | 3 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature decreased | 3 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature increased | 2 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic decreased | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic increased | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram abnormal | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST-T segment abnormal | 1 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate increased | 2 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate decreased | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight increased | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate increased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram abnormal | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Weight decreased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic increased | 2 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST segment depression | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic decreased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure increased | 12 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Electrocardiogram ST-T segment abnormal | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature increased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure decreased | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure systolic decreased | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Body temperature decreased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Heart rate decreased | 0 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | Blood pressure diastolic increased | 0 participants |
Secondary
Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State
Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.
Time frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Population: All participants who received abatacept and had blood samples for assay.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State | 42959.94 µg*h/mL | Full Range 12763.45 |
Secondary
Abatacept PK Parameter: Maximum Serum Concentration at Steady State
Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).
Time frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Population: All participants who received abatacept and had blood samples for assay.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Abatacept PK Parameter: Maximum Serum Concentration at Steady State | 241.62 µg/mL | Full Range 73.96 |
Secondary
Abatacept PK Parameter: Minimum Plasma Concentration at Steady State
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.
Time frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Population: All participants who received abatacept and had blood samples for assay.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Abatacept PK Parameter: Minimum Plasma Concentration at Steady State | 26.14 µg/mL | Full Range 23.1 |
Secondary
Abatacept PK Parameter: Total Body Clearance
Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.
Time frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Population: All participants who received abatacept and had blood samples for assay.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Abatacept PK Parameter: Total Body Clearance | 0.306 L/day | Full Range 0.098 |
Secondary
Baseline and Postbaseline C-reactive Protein (CRP) Levels
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- BL (n=12, 142, 13) | 1.9 mg/dL | Standard Deviation 2.9 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- PBL (n=12, 142, 13) | 1.2 mg/dL | Standard Deviation 1.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- BL (n=3, 7, 1) | 4.6 mg/dL | Standard Deviation 5.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- BL (n=13, 176, 21) | 1.8 mg/dL | Standard Deviation 2.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- PBL (n=3, 7, 1) | 1.4 mg/dL | Standard Deviation 1.7 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- PBL (n=13, 168, 18) | 1.1 mg/dL | Standard Deviation 2.1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- PBL (n=13, 176, 21) | 0.7 mg/dL | Standard Deviation 0.7 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- BL (n=13, 159, 17) | 1.8 mg/dL | Standard Deviation 2.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- PBL (n=13, 159, 17) | 0.9 mg/dL | Standard Deviation 1.3 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- BL (n=13, 168, 18) | 1.8 mg/dL | Standard Deviation 2.8 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- PBL (n=13, 176, 21) | 0.8 mg/dL | Standard Deviation 1.3 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- PBL (n=13, 168, 18) | 0.6 mg/dL | Standard Deviation 1.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- PBL (n=12, 142, 13) | 0.6 mg/dL | Standard Deviation 1.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- BL (n=13, 168, 18) | 2.2 mg/dL | Standard Deviation 2.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- BL (n=13, 176, 21) | 2.3 mg/dL | Standard Deviation 2.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- BL (n=3, 7, 1) | 1.7 mg/dL | Standard Deviation 1.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- PBL (n=13, 159, 17) | 0.5 mg/dL | Standard Deviation 0.9 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- BL (n=13, 159, 17) | 2.3 mg/dL | Standard Deviation 2.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- PBL (n=3, 7, 1) | 0.8 mg/dL | Standard Deviation 1.6 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- BL (n=12, 142, 13) | 2.4 mg/dL | Standard Deviation 2.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- PBL (n=3, 7, 1) | 0.2 mg/dL | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- BL (n=13, 176, 21) | 3.9 mg/dL | Standard Deviation 3.1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 24- PBL (n=13, 176, 21) | 1.9 mg/dL | Standard Deviation 2.5 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- BL (n=13, 168, 18) | 4.1 mg/dL | Standard Deviation 3.1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 48- PBL (n=13, 168, 18) | 0.9 mg/dL | Standard Deviation 1.3 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- BL (n=13, 159, 17) | 4.1 mg/dL | Standard Deviation 3.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 96- PBL (n=13, 159, 17) | 1.0 mg/dL | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- BL (n=12, 142, 13) | 4.2 mg/dL | Standard Deviation 3.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 144- PBL (n=12, 142, 13) | 0.6 mg/dL | Standard Deviation 0.6 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline C-reactive Protein (CRP) Levels | Week 192- BL (n=3, 7, 1) | 8.4 mg/dL | — |
Secondary
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 41.6 Units on a Scale | Standard Deviation 13 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 41.6 Units on a Scale | Standard Deviation 12.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 51.1 Units on a Scale | Standard Deviation 7.6 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 45.7 Units on a Scale | Standard Deviation 20.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 41.6 Units on a Scale | Standard Deviation 12.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 60.7 Units on a Scale | Standard Deviation 6.1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 49.0 Units on a Scale | Standard Deviation 8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 45.2 Units on a Scale | Standard Deviation 8.9 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 41.6 Units on a Scale | Standard Deviation 12.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 49.9 Units on a Scale | Standard Deviation 7.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 48.5 Units on a Scale | Standard Deviation 8.6 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 51.6 Units on a Scale | Standard Deviation 8.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 50.6 Units on a Scale | Standard Deviation 7.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 50.6 Units on a Scale | Standard Deviation 7.3 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 48.6 Units on a Scale | Standard Deviation 8.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 48.6 Units on a Scale | Standard Deviation 8.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 48.6 Units on a Scale | Standard Deviation 8.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 51.2 Units on a Scale | Standard Deviation 7.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 52.4 Units on a Scale | Standard Deviation 12.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 45.4 Units on a Scale | Standard Deviation 8.1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 69.3 Units on a Scale | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 41.7 Units on a Scale | Standard Deviation 9.8 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 49.5 Units on a Scale | Standard Deviation 10.5 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 43.2 Units on a Scale | Standard Deviation 9.6 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 49.9 Units on a Scale | Standard Deviation 7.5 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 43.6 Units on a Scale | Standard Deviation 9.8 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 51.6 Units on a Scale | Standard Deviation 8.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 42.2 Units on a Scale | Standard Deviation 9.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 51.1 Units on a Scale | Standard Deviation 8.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 37.1 Units on a Scale | — |
Secondary
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 40.6 Units on a Scale | Standard Deviation 12.6 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 24.6 Units on a Scale | Standard Deviation 10.9 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 40.9 Units on a Scale | Standard Deviation 11.1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 34.2 Units on a Scale | Standard Deviation 14.5 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 30.4 Units on a Scale | Standard Deviation 24.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 32.9 Units on a Scale | Standard Deviation 14.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 38.7 Units on a Scale | Standard Deviation 12.6 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 34.2 Units on a Scale | Standard Deviation 14.5 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 37.8 Units on a Scale | Standard Deviation 14.5 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 34.2 Units on a Scale | Standard Deviation 14.5 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 38.5 Units on a Scale | Standard Deviation 16.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 40.3 Units on a Scale | Standard Deviation 13.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 30.6 Units on a Scale | Standard Deviation 15.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 39.2 Units on a Scale | Standard Deviation 13.7 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 22.8 Units on a Scale | Standard Deviation 12.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 29.8 Units on a Scale | Standard Deviation 15.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 30.3 Units on a Scale | Standard Deviation 15.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 38.5 Units on a Scale | Standard Deviation 14.3 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 30.4 Units on a Scale | Standard Deviation 15.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 40.1 Units on a Scale | Standard Deviation 13.7 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- PBL (n=12, 142, 13) | 32.9 Units on a Scale | Standard Deviation 14.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- BL (n=13, 160, 17) | 19.9 Units on a Scale | Standard Deviation 12.7 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- PBL (n=13, 176, 23) | 30.3 Units on a Scale | Standard Deviation 17.1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 144- BL (n=12, 142, 13) | 21.1 Units on a Scale | Standard Deviation 14 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- PBL (n=13, 170, 18) | 37.1 Units on a Scale | Standard Deviation 14 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 48- BL (n=13, 170, 18) | 20.1 Units on a Scale | Standard Deviation 12.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- PBL (n=3, 7, 1) | 37.0 Units on a Scale | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 192- BL (n=3, 7, 1) | 12.5 Units on a Scale | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 96- PBL (n=13, 160, 17) | 37.5 Units on a Scale | Standard Deviation 13.5 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | Week 24- BL (n=13, 176, 23) | 19.0 Units on a Scale | Standard Deviation 12.5 |
Secondary
Baseline and Postbaseline Rheumatoid Factor Levels
Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please see outcome 20 for change from BL data.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- BL (n=13, 176, 21) | 200.2 IU/mL | Standard Deviation 343.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- PBL (n=13, 176, 21) | 127.5 IU/mL | Standard Deviation 191.6 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- BL (n=13, 168, 18) | 200.2 IU/mL | Standard Deviation 343.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- PBL (n=13, 168, 18) | 139.9 IU/mL | Standard Deviation 241.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- BL (n=13, 159, 17) | 200.2 IU/mL | Standard Deviation 343.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- PBL (n=13, 159, 17) | 186.9 IU/mL | Standard Deviation 339.4 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- BL (n=12, 142, 13) | 205.6 IU/mL | Standard Deviation 358.5 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- PBL (n=12, 142, 13) | 211.3 IU/mL | Standard Deviation 359.8 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- BL (n=3, 7, 1) | 314.3 IU/mL | Standard Deviation 455.3 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- PBL (n=3, 7, 1) | 315.0 IU/mL | Standard Deviation 307 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- BL (n=3, 7, 1) | 253.7 IU/mL | Standard Deviation 307.6 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- BL (n=13, 176, 21) | 214.3 IU/mL | Standard Deviation 383.3 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- PBL (n=13, 159, 17) | 151.0 IU/mL | Standard Deviation 285.8 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- BL (n=13, 159, 17) | 215.9 IU/mL | Standard Deviation 393.9 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- PBL (n=13, 176, 21) | 141.0 IU/mL | Standard Deviation 289.2 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- PBL (n=3, 7, 1) | 348.4 IU/mL | Standard Deviation 521.6 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- PBL (n=12, 142, 13) | 173.7 IU/mL | Standard Deviation 360.8 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- BL (n=13, 168, 18) | 217.3 IU/mL | Standard Deviation 389.7 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- BL (n=12, 142, 13) | 229.0 IU/mL | Standard Deviation 412.6 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- PBL (n=13, 168, 18) | 149.5 IU/mL | Standard Deviation 288.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- PBL (n=12, 142, 13) | 361.6 IU/mL | Standard Deviation 663.9 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- PBL (n=13, 168, 18) | 288.3 IU/mL | Standard Deviation 482.8 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- BL (n=13, 159, 17) | 590.9 IU/mL | Standard Deviation 911.1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 96- PBL (n=13, 159, 17) | 216.8 IU/mL | Standard Deviation 329.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- BL (n=3, 7, 1) | 2800.0 IU/mL | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 144- BL (n=12, 142, 13) | 639.4 IU/mL | Standard Deviation 990.8 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- BL (n=13, 176, 21) | 630.8 IU/mL | Standard Deviation 873.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 192- PBL (n=3, 7, 1) | 197.0 IU/mL | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 24- PBL (n=13, 176, 21) | 573.9 IU/mL | Standard Deviation 897.2 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline and Postbaseline Rheumatoid Factor Levels | Week 48- BL (n=13, 168, 18) | 560.9 IU/mL | Standard Deviation 893 |
Secondary
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of \> 5.1), low disease activity (change of ≤ 3.2) and remission (\< 2.6). Please see outcome 8 for change from BL data.
Time frame: At BL (week 0), week 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- BL (n=13, 176, 21) | 4.4 Units on a Scale | Standard Deviation 1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- PBL (n=3, 7, 1) | 2.6 Units on a Scale | Standard Deviation 1.2 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- PBL (n=12, 142, 13) | 3.0 Units on a Scale | Standard Deviation 0.9 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- PBL (n=13, 176, 21) | 3.0 Units on a Scale | Standard Deviation 1.1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- PBL (n=13, 159, 17) | 3.3 Units on a Scale | Standard Deviation 1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- BL (n=3, 7, 1) | 4.6 Units on a Scale | Standard Deviation 1.6 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- BL (n=13, 168, 18) | 4.4 Units on a Scale | Standard Deviation 1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- BL (n=12, 142, 13) | 4.3 Units on a Scale | Standard Deviation 0.9 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- PBL (n=13, 168, 18) | 3.0 Units on a Scale | Standard Deviation 1.1 |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- BL (n=13, 159, 17) | 4.4 Units on a Scale | Standard Deviation 1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- PBL (n=13, 168, 18) | 2.9 Units on a Scale | Standard Deviation 1.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- BL (n=13, 159, 17) | 4.8 Units on a Scale | Standard Deviation 1.4 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- BL (n=12, 142, 13) | 4.9 Units on a Scale | Standard Deviation 1.4 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- PBL (n=12, 142, 13) | 2.8 Units on a Scale | Standard Deviation 1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- BL (n=3, 7, 1) | 5.4 Units on a Scale | Standard Deviation 0.9 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- PBL (n=3, 7, 1) | 3.1 Units on a Scale | Standard Deviation 1.4 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- BL (n=13, 176, 21) | 4.8 Units on a Scale | Standard Deviation 1.4 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- PBL (n=13, 176, 21) | 3.2 Units on a Scale | Standard Deviation 1.1 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- BL (n=13, 168, 18) | 4.8 Units on a Scale | Standard Deviation 1.4 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- PBL (n=13, 159, 17) | 2.8 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- PBL (n=13, 176, 21) | 4.0 Units on a Scale | Standard Deviation 1.9 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- BL (n=13, 159, 17) | 6.2 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- BL (n=12, 142, 13) | 6.3 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- BL (n=3, 7, 1) | 7.9 Units on a Scale | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 192- PBL (n=3, 7, 1) | 1.9 Units on a Scale | — |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 24- BL (n=13, 176, 21) | 6.3 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- BL (n=13, 168, 18) | 6.3 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 48- PBL (n=13, 168, 18) | 3.5 Units on a Scale | Standard Deviation 1.4 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 96- PBL (n=13, 159, 17) | 3.2 Units on a Scale | Standard Deviation 1 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | Week 144- PBL (n=12, 142, 13) | 3.2 Units on a Scale | Standard Deviation 1.2 |
Secondary
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Please refer to outcome 7 for BL and PBL values.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | -2.0 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -1.3 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -1.4 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -1.1 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -1.4 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -2.0 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -1.7 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -2.1 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | -2.3 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -1.9 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | -6.0 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -2.8 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -2.3 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -3.0 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -3.1 Units on a Scale |
Secondary
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.
Time frame: At BL (Week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 3.6 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 9.5 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 8.3 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 15.0 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 7.4 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 2.1 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 2.6 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 3.0 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 2.1 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 7.0 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 6.7 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 8.9 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 7.7 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 32.1 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 8.0 Units on a Scale |
Secondary
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \>3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.
Time frame: At baseline (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 5.7 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 4.5 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 6.7 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 4.8 Units on a Scale |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 6.5 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 8.6 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 15.7 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 8.2 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 9.7 Units on a Scale |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 10.4 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 23) | 11.3 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 11.8 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 160, 17) | 17.6 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 24.6 Units on a Scale |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 170, 18) | 17.1 Units on a Scale |
Secondary
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please refer to outcome 19 for BL and PBL values.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 5.7 IU/mL |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -72.6 IU/mL |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -60.2 IU/mL |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -13.2 IU/mL |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 0.7 IU/mL |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -67.8 IU/mL |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 94.7 IU/mL |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -64.9 IU/mL |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -55.3 IU/mL |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -73.2 IU/mL |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -56.9 IU/mL |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | -272.6 IU/mL |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -277.8 IU/mL |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | -2603 IU/mL |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -374.1 IU/mL |
Secondary
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score \< 2.6 were considered to be in remission.
Time frame: At weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 4 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 3 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 6 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 4 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 2 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 75 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 60 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 75 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 71 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 2 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 3 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 6 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 5 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 5 participants |
Secondary
Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies
Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.
Time frame: At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.
Population: All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-abatacept antibody | 2 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-CTLA4-T antibody | 0 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-abatacept antibody | 19 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-CTLA4-T antibody | 19 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-abatacept antibody | 2 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Positive for anti-CTLA4-T antibody | 1 participants |
Secondary
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 6 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | 9 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 3 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | 7 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 8 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 107 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 114 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 5 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | 113 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | 111 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | 17 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 12 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | 16 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 16 participants |
Secondary
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.
Time frame: At weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 6 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 9 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 9 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 6 participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 2 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 105 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 3 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 101 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 95 participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 95 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 21) | 6 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 168, 18) | 7 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 7 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 1 participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 159, 17) | 6 participants |
Secondary
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value \* 100. Please refer to outcome 17 for BL and PBL values.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -71.9 percentage improvement |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | -3.3 percentage improvement |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | -18.4 percentage improvement |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 12.0 percentage improvement |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 67.9 percentage improvement |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | 40.5 percentage improvement |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | 30.5 percentage improvement |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 31.9 percentage improvement |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | -39.3 percentage improvement |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 39.7 percentage improvement |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 192 (n=3, 7, 1) | 97.4 percentage improvement |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 144 (n=12, 142, 13) | 79.9 percentage improvement |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 24 (n=13, 176, 21) | 60.2 percentage improvement |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 96 (n=13, 159, 17) | 70.1 percentage improvement |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | Week 48 (n=13, 168, 18) | 77.8 percentage improvement |
Secondary
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.
Time frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 100.0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 23) | 38.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 170, 18) | 30.8 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 160, 17) | 46.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 50.0 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 160, 17) | 47.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 48.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 23) | 39.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 85.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 170, 18) | 41.2 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 144 (n=12, 142, 13) | 69.2 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 48 (n=13, 170, 18) | 77.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 96 (n=13, 160, 17) | 76.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 192 (n=3, 7, 1) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | Week 24 (n=13, 176, 23) | 52.2 percentage of participants |
Secondary
Percentage of Participants With ACR 50 Response Over Time
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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Time frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 36; (n=13, 175, 20) | 38.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 156; (n=11, 113, 12) | 36.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 60; (n=13, 165, 17) | 30.8 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 180; (n=8, 56, 4) | 12.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 144; (n=12, 142, 13) | 25.0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 72; (n=13, 161, 17) | 46.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 12; (n=13, 178,24) | 38.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 192; (n=3, 7, 1) | 66.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 84; (n=13, 161, 17) | 38.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 168; (n=10, 80, 8) | 30.0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 24; (n=13, 176, 23) | 30.8 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 96; (n=13, 160, 17) | 23.1 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 108; (n=13, 156, 15) | 23.1 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 48; (n=13, 170, 18) | 15.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 4; (n=13, 178, 26) | 15.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 120; (n=13, 154, 15) | 46.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 132; (n=13, 151, 14) | 38.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 48; (n=13, 170, 18) | 38.8 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 4; (n=13, 178, 26) | 6.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 144; (n=12, 142, 13) | 47.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 156; (n=11, 113, 12) | 47.8 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 168; (n=10, 80, 8) | 47.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 12; (n=13, 178,24) | 16.3 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 180; (n=8, 56, 4) | 51.8 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 36; (n=13, 175, 20) | 28.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 192; (n=3, 7, 1) | 71.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 132; (n=13, 151, 14) | 43.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 96; (n=13, 160, 17) | 38.1 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 60; (n=13, 165, 17) | 42.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 24; (n=13, 176, 23) | 25.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 72; (n=13, 161, 17) | 43.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 120; (n=13, 154, 15) | 45.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 84; (n=13, 161, 17) | 42.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 108; (n=13, 156, 15) | 42.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 192; (n=3, 7, 1) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 24; (n=13, 176, 23) | 47.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 96; (n=13, 160, 17) | 58.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 120; (n=13, 154, 15) | 93.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 4; (n=13, 178, 26) | 0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 36; (n=13, 175, 20) | 50.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 48; (n=13, 170, 18) | 72.2 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 60; (n=13, 165, 17) | 58.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 72; (n=13, 161, 17) | 70.6 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 84; (n=13, 161, 17) | 70.6 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 108; (n=13, 156, 15) | 66.7 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 132; (n=13, 151, 14) | 85.7 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 144; (n=12, 142, 13) | 69.2 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 156; (n=11, 113, 12) | 83.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 168; (n=10, 80, 8) | 87.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 180; (n=8, 56, 4) | 75.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 50 Response Over Time | Week 12; (n=13, 178,24) | 29.2 percentage of participants |
Secondary
Percentage of Participants With ACR 70 Response Over Time
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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Time frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 168; (n=10, 80, 8) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 156; (n=11, 113, 12) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 60; (n=13, 165, 17) | 15.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 4; (n=13, 178, 26) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 180; (n=8, 56, 4) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 12; (n=13, 178, 24) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 84; (n=13, 161, 17) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 144; (n=12, 142, 13) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 48; (n=13, 170, 18) | 15.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 96; (n=13, 160, 17) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 192; (n=3, 7, 1) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 132; (n=13, 151, 14) | 0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 108; (n=13, 156, 15) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 36; (n=13, 175, 20) | 15.4 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 24; (n=13, 176, 23) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 120; (n=13, 154, 15) | 7.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 72; (n=13, 161, 17) | 15.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 120; (n=13, 154, 15) | 19.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 132; (n=13, 151, 14) | 20.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 144; (n=12, 142, 13) | 21.8 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 156; (n=11, 113, 12) | 25.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 36; (n=13, 175, 20) | 11.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 168; (n=10, 80, 8) | 27.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 180; (n=8, 56, 4) | 33.9 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 192; (n=3, 7, 1) | 14.3 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 48; (n=13, 170, 18) | 15.3 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 4; (n=13, 178, 26) | 0 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 60; (n=13, 165, 17) | 19.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 72; (n=13, 161, 17) | 18.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 84; (n=13, 161, 17) | 17.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 12; (n=13, 178, 24) | 5.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 96; (n=13, 160, 17) | 19.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 108; (n=13, 156, 15) | 15.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 24; (n=13, 176, 23) | 10.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 192; (n=3, 7, 1) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 4; (n=13, 178, 26) | 0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 12; (n=13, 178, 24) | 8.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 24; (n=13, 176, 23) | 21.7 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 36; (n=13, 175, 20) | 20.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 48; (n=13, 170, 18) | 27.8 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 60; (n=13, 165, 17) | 29.4 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 72; (n=13, 161, 17) | 23.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 84; (n=13, 161, 17) | 23.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 96; (n=13, 160, 17) | 23.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 108; (n=13, 156, 15) | 33.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 120; (n=13, 154, 15) | 46.7 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 132; (n=13, 151, 14) | 42.9 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 144; (n=12, 142, 13) | 23.1 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 156; (n=11, 113, 12) | 33.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 168; (n=10, 80, 8) | 62.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With ACR 70 Response Over Time | Week 180; (n=8, 56, 4) | 50.0 percentage of participants |
Secondary
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
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 activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Time frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Population: All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 168; (n=10, 80, 8) | 80.0 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 4; (n=13, 178,26) | 30.8 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 60; (n=13, 165, 17) | 69.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 36; (n=13, 175, 20) | 69.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 156; (n=11, 113, 12) | 63.6 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 72; (n=13, 161, 17) | 84.6 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 84; (n=13, 161, 17) | 61.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 180; (n=8, 56, 4) | 62.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 144; (n=12, 142, 13) | 58.3 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 96; (n=13, 160, 17) | 69.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 48; (n=13, 170, 18) | 61.5 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 192; (n=3, 7, 1) | 66.7 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 108; (n=13, 156, 15) | 53.8 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 120; (n=13, 154, 15) | 69.2 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 24; (n=13, 176, 23) | 76.9 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 12; (n=13, 178,24) | 76.9 percentage of participants |
| Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 132; (n=13, 151, 14) | 61.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 24; (n=13, 176, 23) | 59.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 144; (n=12, 142, 13) | 69.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 156; (n=11, 113, 12) | 66.4 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 36; (n=13, 175, 20) | 61.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 168; (n=10, 80, 8) | 71.3 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 132; (n=13, 151, 14) | 68.9 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 180; (n=8, 56, 4) | 69.6 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 192; (n=3, 7, 1) | 85.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 48; (n=13, 170, 18) | 63.5 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 60; (n=13, 165, 17) | 69.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 4; (n=13, 178,26) | 29.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 84; (n=13, 161, 17) | 67.1 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 72; (n=13, 161, 17) | 67.7 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 96; (n=13, 160, 17) | 63.8 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 12; (n=13, 178,24) | 47.2 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 108; (n=13, 156, 15) | 67.9 percentage of participants |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 120; (n=13, 154, 15) | 69.5 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 192; (n=3, 7, 1) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 72; (n=13, 161, 17) | 94.1 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 4; (n=13, 178,26) | 34.6 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 12; (n=13, 178,24) | 58.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 24; (n=13, 176, 23) | 78.3 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 36; (n=13, 175, 20) | 90.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 48; (n=13, 170, 18) | 88.9 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 60; (n=13, 165, 17) | 94.1 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 84; (n=13, 161, 17) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 96; (n=13, 160, 17) | 82.4 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 108; (n=13, 156, 15) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 120; (n=13, 154, 15) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 132; (n=13, 151, 14) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 144; (n=12, 142, 13) | 84.6 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 156; (n=11, 113, 12) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 168; (n=10, 80, 8) | 100.0 percentage of participants |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | Week 180; (n=8, 56, 4) | 100.0 percentage of participants |