Arthritis, Rheumatoid
Conditions
Brief summary
The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).
Interventions
DRUGAbatacept
solution, intravenous injection, monthly, 169 days weight based: \<60 kg = 500 mg 60 to 100 kg = 750 mg \>100 kg = 1 g
DRUGplacebo
solution, intravenous injection, 0 mg, monthly, 169 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of undifferentiated arthritis * Clinical synovitis of two or more joints * At least one but not more than three of the criteria for diagnosis of RA (1987). * No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics. * Duration of disease must be 18 months or less. * Positive for antibodies against cyclic citrullinated peptides.
Exclusion criteria
* Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy. * Active vasculitis of a major organ system. * Severe or recurrent bacterial infection. * History of cancer in the last five years except certain skin cancers. * Herpes zoster that resolved less than 2 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy | 12 months | ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy | 24 months | ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also. |
| Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease | 12 months, 24 months | Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also. |
| Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Baseline, 6 months, 12 months, 24 months | Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement. |
| Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Baseline, 6 months, 12 months, 24 months | Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score. |
| Number of Participants With Persistent Symptomatic Clinical Synovitis | 6, 12, and 24 months | Synovitis, assessed by clinical signs and symptoms |
| Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | 6 months, 12 months, 24 months | SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement. |
| Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Baseline, 6 Months, 12 months, 24 months | To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 \[IL-6\], interleukin-1B \[IL-1B\], tumor necrosis factor Alpha \[TNF-Alpha\], Matrix Metalloproteinase 3T \[MMP3T\], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement. |
| Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Day 1, 6 months, 12 months, 24 months | To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive |
| Frequency of Human Leukocyte Antigen (HLA) Typing | Day 1 | To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404). |
| DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 6 months, 12 months, 24 months | The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement. |
| Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | 6 months, 12 months, 24 months | The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (\< 2.6). |
| Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 6 months, 12 months, 24 months | This questionnaire includes 20 questions assessing physical function in 8 domains. 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 indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline. |
| Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Throughout the treatment period (6 months) | AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely |
| Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies | Up to 12 months | Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of \> 400 and for tip assessment was ≥25. |
Countries
Australia, Belgium, France, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
184 participants were screened, 127 were enrolled but not randomized (5 withdrew consent; 120 no longer met study criteria; 2 other reasons). 57 participants were randomized, 1 participant was randomized but not treated.
Participants by arm
| Arm | Count |
|---|---|
| Abatacept Abatacept by IV infusion, dose based on participant's body weight at the screening visit | 28 |
| Placebo Placebo (dextrose 5% in water \[D5W\] or normal saline \[NS\]) by IV infusion. | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 18-Month Untreated Observation Period | Adverse Event | 0 | 1 |
| 18-Month Untreated Observation Period | Lack of Efficacy | 11 | 12 |
| 18-Month Untreated Observation Period | Lost to Follow-up | 1 | 0 |
| 18-Month Untreated Observation Period | Poor/Noncompliance | 1 | 0 |
| 18-Month Untreated Observation Period | Pregnancy | 1 | 0 |
| 18-Month Untreated Observation Period | Relocated | 1 | 0 |
| 6-month Double-Blind Treatment Period | Adverse Event | 1 | 0 |
| 6-month Double-Blind Treatment Period | Exposure to mycobacterium tuberculosis | 0 | 1 |
| 6-month Double-Blind Treatment Period | Lack of Efficacy | 3 | 8 |
| 6-month Double-Blind Treatment Period | Poor/Noncompliance | 1 | 0 |
| 6-month Double-Blind Treatment Period | Sponsor request | 0 | 1 |
| 6-month Double-Blind Treatment Period | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Abatacept | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.5 years | 44.0 years | 44.0 years |
| Months of Undifferentiated Inflammatory Arthritis (UA) | 8.8 Months STANDARD_DEVIATION 4.2 | 7.1 Months STANDARD_DEVIATION 4.4 | 7.9 Months STANDARD_DEVIATION 4.3 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment Europe | 17 participants | 21 participants | 38 participants |
| Region of Enrollment North America | 6 participants | 5 participants | 11 participants |
| Region of Enrollment South America | 5 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
| Weight | 75.9 Kilograms STANDARD_DEVIATION 22.5 | 70.9 Kilograms STANDARD_DEVIATION 13.9 | 73.4 Kilograms STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 28 | 13 / 28 |
| serious Total, serious adverse events | 1 / 28 | 1 / 28 |
Outcome results
Primary
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.
Time frame: 12 months
Population: Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 1-year window were excluded from the analysis). 1 participant in Placebo group was excluded due to presence of RA at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy | 12 Participants |
| Placebo | Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy | 16 Participants |
Secondary
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 \[IL-6\], interleukin-1B \[IL-1B\], tumor necrosis factor Alpha \[TNF-Alpha\], Matrix Metalloproteinase 3T \[MMP3T\], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.
Time frame: Baseline, 6 Months, 12 months, 24 months
Population: All randomized and treated participants (n=number of participants with baseline and postbaseline measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 12 months (n=13, n=7) | -0.14 laboratory values | Standard Error 1.61 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 6 months (n=20, n=19) | -2.29 laboratory values | Standard Error 4.86 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 24 months (n=5, n=1) | 0.20 laboratory values | Standard Error 0.2 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 12 months (n=15, n=9) | -2.55 laboratory values | Standard Error 3.08 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 6 months (n=18, n=18) | -0.12 laboratory values | Standard Error 0.07 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 24 months (n=6, n=3) | 6.73 laboratory values | Standard Error 6.93 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 6 months (n=18, n=18) | -1.70 laboratory values | Standard Error 1.29 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 6 months (n=21, n=19) | -94.5 laboratory values | Standard Error 29.49 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 24 months (n=5, n=3) | -3.44 laboratory values | Standard Error 3.54 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 12 months (n=14, n=10) | -6.46 laboratory values | Standard Error 48.09 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 24 months (n=6, n=3) | 3.43 laboratory values | Standard Error 53.85 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 12 months (n=13, n=7) | -0.09 laboratory values | Standard Error 0.07 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 24 months (n=13, n=7) | -0.82 laboratory values | Standard Error 0.47 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 12 months (n=13, n=7) | -0.50 laboratory values | Standard Error 0.25 |
| Abatacept | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 6 months (n=19, n=18) | -4.49 laboratory values | Standard Error 1.78 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 12 months (n=14, n=10) | 149.5 laboratory values | Standard Error 64.38 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 6 months (n=19, n=18) | 1.08 laboratory values | Standard Error 0.72 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 24 months (n=5, n=3) | 0.90 laboratory values | Standard Error 1.51 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 6 months (n=18, n=18) | -0.09 laboratory values | Standard Error 0.08 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 12 months (n=13, n=7) | -0.24 laboratory values | Standard Error 0.21 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL1B at 24 months (n=5, n=1) | 0.00 laboratory values | Standard Error 0 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 6 months (n=18, n=18) | 0.07 laboratory values | Standard Error 0.28 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 12 months (n=13, n=7) | -0.10 laboratory values | Standard Error 0.33 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | TNF-Alpha at 24 months (n=13, n=7) | -0.03 laboratory values | Standard Error 0.03 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 6 months (n=20, n=19) | 14.34 laboratory values | Standard Error 9.85 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 12 months (n=15, n=9) | 25.34 laboratory values | Standard Error 14.59 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | MMP3T at 24 months (n=6, n=3) | 3.10 laboratory values | Standard Error 3.45 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 6 months (n=21, n=19) | 16.32 laboratory values | Standard Error 21.49 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | Anti-CCP2 antibodies at 24 months (n=6, n=3) | -35.1 laboratory values | Standard Error 55.65 |
| Placebo | Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months | IL6 at 12 months (n=13, n=7) | 6.37 laboratory values | Standard Error 3.81 |
Secondary
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.
Time frame: Baseline, 6 months, 12 months, 24 months
Population: n=participants with a score at baseline and at timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 6 months (n=22; n=21) | 0.00 units on a scale | Standard Error 0 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 12 months (n=17; n=11) | 0.02 units on a scale | Standard Error 0.04 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 12 months (n=17; n=11) | 0.00 units on a scale | Standard Error 0 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 24 months (n=7; n=3) | 0.04 units on a scale | Standard Error 0.04 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 12 months (n=17; n=11) | 0.02 units on a scale | Standard Error 0.04 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 24 months (n=7; n=3) | 0.00 units on a scale | Standard Error 0 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 6 months (n=22; n=21) | 0.13 units on a scale | Standard Error 0.09 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 24 months (n=7; n=3) | 0.04 units on a scale | Standard Error 0.04 |
| Abatacept | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 6 months (n=22; n=21) | 0.13 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 24 months (n=7; n=3) | -0.17 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 6 months (n=22; n=21) | 0.01 units on a scale | Standard Error 0.01 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 6 months (n=22; n=21) | 0.46 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 6 months (n=22; n=21) | 0.47 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 12 months (n=17; n=11) | 0.85 units on a scale | Standard Error 0.39 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 12 months (n=17; n=11) | 0.26 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Total Score 12 months (n=17; n=11) | 1.11 units on a scale | Standard Error 0.56 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Erosion Score 24 months (n=7; n=3) | -0.17 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months | Joint Space Narrowing 24 months (n=7; n=3) | 0.00 units on a scale | Standard Error 0 |
Secondary
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.
Time frame: Baseline, 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=number of participants with baseline and postbaseline measurements). MRIs were done only in participants at European Union sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 6 months (n=11; n=10) | 0.45 units on a scale | Standard Error 0.37 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 6 months (n=11; n=10) | -1.64 units on a scale | Standard Error 1.48 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 6 months (n=11; n=10) | 0.27 units on a scale | Standard Error 0.56 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 12 months (n=9; n=6) | 0.00 units on a scale | Standard Error 0.17 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 12 months (n=9; n=6) | 0.22 units on a scale | Standard Error 0.49 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 12 months (n=9; n=6) | 0.22 units on a scale | Standard Error 0.22 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 24 months (n=5; n=2) | 0.80 units on a scale | Standard Error 0.49 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 24 months (n=5; n=2) | 0.20 units on a scale | Standard Error 0.2 |
| Abatacept | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 24 months (n=5; n=2) | 0.60 units on a scale | Standard Error 0.6 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 24 months (n=5; n=2) | 0.50 units on a scale | Standard Error 0.5 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 6 months (n=11; n=10) | 1.20 units on a scale | Standard Error 1.09 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 12 months (n=9; n=6) | 2.33 units on a scale | Standard Error 1.61 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 6 months (n=11; n=10) | 1.40 units on a scale | Standard Error 1.59 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 12 months (n=9; n=6) | 5.00 units on a scale | Standard Error 3.2 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 6 months (n=11; n=10) | 1.60 units on a scale | Standard Error 1.23 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Erosion Score at 24 months (n=5; n=2) | 0.00 units on a scale | Standard Error 0 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Synovitis Score at 24 months (n=5; n=2) | 1.50 units on a scale | Standard Error 2.5 |
| Placebo | Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months | Edema Score at 12 months (n=9; n=6) | 6.67 units on a scale | Standard Error 4.22 |
Secondary
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.
Time frame: 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 6 Months (n=20; n=20) | -1.13 units on a scale | Standard Error 0.2 |
| Abatacept | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 12 Months (n=18; n=13) | -0.50 units on a scale | Standard Error 0.22 |
| Abatacept | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 24 Months (n=6; n=4) | -0.33 units on a scale | Standard Error 0.33 |
| Placebo | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 6 Months (n=20; n=20) | 0.01 units on a scale | Standard Error 0.26 |
| Placebo | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 12 Months (n=18; n=13) | -0.05 units on a scale | Standard Error 0.42 |
| Placebo | DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline | 24 Months (n=6; n=4) | 0.69 units on a scale | Standard Error 1.16 |
Secondary
Frequency of Human Leukocyte Antigen (HLA) Typing
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).
Time frame: Day 1
Population: All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Frequency of Human Leukocyte Antigen (HLA) Typing | Undetected | 11 participants |
| Abatacept | Frequency of Human Leukocyte Antigen (HLA) Typing | Missing | 4 participants |
| Abatacept | Frequency of Human Leukocyte Antigen (HLA) Typing | Detected | 13 participants |
| Placebo | Frequency of Human Leukocyte Antigen (HLA) Typing | Missing | 7 participants |
| Placebo | Frequency of Human Leukocyte Antigen (HLA) Typing | Undetected | 10 participants |
| Placebo | Frequency of Human Leukocyte Antigen (HLA) Typing | Detected | 11 participants |
Secondary
Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (\< 2.6).
Time frame: 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 6 months (n=21; n=20) | 17 Participants |
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 6 months (n=21; n=20) | 15 Participants |
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 12 months (n=19; n=13) | 13 Participants |
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 12 months (n=19; n=13) | 9 Participants |
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 24 months (n=7; n=4) | 5 Participants |
| Abatacept | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 24 months (n=7; n=4) | 4 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 24 months (n=7; n=4) | 2 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 6 months (n=21; n=20) | 9 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 12 months (n=19; n=13) | 5 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 6 months (n=21; n=20) | 7 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | <2.6 at 24 months (n=7; n=4) | 2 Participants |
| Placebo | Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) | ≤3.2 at 12 months (n=19; n=13) | 7 Participants |
Secondary
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
Time frame: 24 months
Population: Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 2-year window were excluded from the analysis). 1 subject in the Placebo group is excluded due to presence of RA at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy | 17 Participants |
| Placebo | Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy | 21 Participants |
Secondary
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive
Time frame: Day 1, 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=number of participants with measure at timepoint).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive on Day 1 (n=28, n=28) | 28 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 6 months (n=22, n=19) | 20 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 12 months (n=15, n=10) | 13 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 24 months (n=6, n=3) | 5 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF on Day 1 (n=28, n=28) | 24 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 6 months (n=22, n=20) | 13 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 12 months (n=15, n=10) | 11 Participants |
| Abatacept | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 24 months (n=6, n=3) | 3 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 24 months (n=6, n=3) | 3 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive on Day 1 (n=28, n=28) | 28 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF on Day 1 (n=28, n=28) | 20 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 6 months (n=22, n=19) | 19 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 12 months (n=15, n=10) | 8 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 12 months (n=15, n=10) | 10 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | RF at 6 months (n=22, n=20) | 14 Participants |
| Placebo | Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time | Anti-CCP2 Positive at 24 months (n=6, n=3) | 3 Participants |
Secondary
Number of Participants With Persistent Symptomatic Clinical Synovitis
Synovitis, assessed by clinical signs and symptoms
Time frame: 6, 12, and 24 months
Population: All randomized and treated participants (n=number of participants with assessment at baseline and timepoint)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Number of Participants With Persistent Symptomatic Clinical Synovitis | 6 months (n=5; n=12) | 4 Participants |
| Abatacept | Number of Participants With Persistent Symptomatic Clinical Synovitis | 12 months (n=11; n=7) | 10 Participants |
| Abatacept | Number of Participants With Persistent Symptomatic Clinical Synovitis | 24 months (n=3; n=2) | 3 Participants |
| Placebo | Number of Participants With Persistent Symptomatic Clinical Synovitis | 6 months (n=5; n=12) | 12 Participants |
| Placebo | Number of Participants With Persistent Symptomatic Clinical Synovitis | 12 months (n=11; n=7) | 7 Participants |
| Placebo | Number of Participants With Persistent Symptomatic Clinical Synovitis | 24 months (n=3; n=2) | 2 Participants |
Secondary
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of \> 400 and for tip assessment was ≥25.
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies | 4 participants |
Secondary
Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
Time frame: 12 months, 24 months
Population: n=Randomized and treated participants who were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in the 1- or 2-year window were excluded from the analysis).1 participant in Placebo group was excluded due to the presence of RA at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease | 12 months (n=26; n=24) | 0 Participants |
| Abatacept | Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease | 24 months (n=23; n=24) | 0 Participants |
| Placebo | Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease | 12 months (n=26; n=24) | 0 Participants |
| Placebo | Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease | 24 months (n=23; n=24) | 0 Participants |
Secondary
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
This questionnaire includes 20 questions assessing physical function in 8 domains. 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 indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.
Time frame: 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 12 months (n=25; n=25) | 9 Participants |
| Abatacept | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 24 months (n=21; n=24) | 3 Participants |
| Abatacept | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 6 Months (n=26; n=25) | 16 Participants |
| Placebo | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 12 months (n=25; n=25) | 3 Participants |
| Placebo | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 24 months (n=21; n=24) | 1 Participants |
| Placebo | Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response | 6 Months (n=26; n=25) | 6 Participants |
Secondary
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely
Time frame: Throughout the treatment period (6 months)
Population: All subjects who received at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Deaths | 0 Participants |
| Abatacept | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | AEs | 18 Participants |
| Abatacept | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Related AEs | 14 Participants |
| Abatacept | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Discontinued due to AEs | 1 Participants |
| Abatacept | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | SAEs | 1 Participants |
| Placebo | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | SAEs | 1 Participants |
| Placebo | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Discontinued due to AEs | 1 Participants |
| Placebo | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | AEs | 20 Participants |
| Placebo | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Deaths | 0 Participants |
| Placebo | Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths | Related AEs | 10 Participants |
Secondary
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.
Time frame: 6 months, 12 months, 24 months
Population: All randomized and treated participants (n=number of participants with baseline and postbaseline measurements)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 6 months (n=26; n=20) | 10.23 units on a scale | Standard Error 1.68 |
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 6 months (n=26; n=20) | 2.54 units on a scale | Standard Error 1.33 |
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 12 months (n=20; n=14) | 3.83 units on a scale | Standard Error 2.38 |
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 12 months (n=20; n=14) | 2.50 units on a scale | Standard Error 1.75 |
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 24 months (n=7; n=5) | 3.75 units on a scale | Standard Error 1.99 |
| Abatacept | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 24 months (n=7; n=5) | 2.46 units on a scale | Standard Error 3.15 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 12 months (n=20; n=14) | -2.89 units on a scale | Standard Error 2.85 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 6 months (n=26; n=20) | 1.95 units on a scale | Standard Error 1.52 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 24 months (n=7; n=5) | -2.17 units on a scale | Standard Error 6.44 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 6 months (n=26; n=20) | -0.30 units on a scale | Standard Error 1.29 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | MCS, 24 months (n=7; n=5) | -3.30 units on a scale | Standard Error 7.58 |
| Placebo | Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline | PCS, 12 months (n=20; n=14) | -0.81 units on a scale | Standard Error 2.26 |