Phase 2
N=56
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
Arthritis, Rheumatoid
Bottom Line
View on ClinicalTrials.gov: NCT00124449 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Nov 2009
Primary outcome: 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 — 12; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abatacept (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
12; 16 | — |
| SECONDARY Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy |
17; 21 | — |
| SECONDARY Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months |
0.13; 0.46; 0.00; 0.01; 0.13; 0.47 | — |
| SECONDARY Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months |
0.45; 1.20; -1.64; 1.40; 0.27; 1.60 | — |
| SECONDARY Number of Participants With Persistent Symptomatic Clinical Synovitis |
4; 12; 10; 7; 3; 2 | — |
| SECONDARY Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline |
10.23; 1.95; 2.54; -0.30; 3.83; -0.81 | — |
| 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 |
-4.49; 1.08; -0.14; 6.37; -3.44; 0.90 | — |
| SECONDARY Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time |
28; 28; 20; 19; 13; 10 | — |
| SECONDARY Frequency of Human Leukocyte Antigen (HLA) Typing |
4; 7; 11; 10; 13; 11 | — |
| SECONDARY DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline |
-1.13; 0.01; -0.50; -0.05; -0.33; 0.69 | — |
| SECONDARY Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission) |
17; 9; 15; 7; 13; 7 | — |
| SECONDARY Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response |
16; 6; 9; 3; 3; 1 | — |
| SECONDARY Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths |
0; 0; 1; 1; 18; 20 | — |
| SECONDARY Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies |
4 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00124449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.