Phase 3
Completed N=994
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02504268 ↗Enrolled (actual)
994
Serious AEs
5.6%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 — 21.3; 16.0 Percentage of participants — p=0.2359
◆ Published Evidence
Emerging
14citations · ~5 / year
Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis.
Summary
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.
Linked Publications (4)
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Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis.
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The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study.
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Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis.
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Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 |
21.3; 16.0 | 0.2359 |
| SECONDARY Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 |
38.7; 25.3 | 0.0112 sig |
| SECONDARY Percentage of Participants in SDAI Remission at Week 52 |
29.8; 15.3 | 0.0021 sig |
| SECONDARY Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52 |
0.53; 2.52 | < 0.0001 sig |
| SECONDARY Percentage of Participants in Boolean Remission at Week 52 |
21.5; 11.6 | 0.0006 sig |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Rheumatoid arthritis (RA) diagnosis less than 6 months
- CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
- At least 3 swollen and 3 tender joints
- Anti-citrullinated protein antibodies (ACPA) positive
Exclusion Criteria
- At risk for tuberculosis
- Have acute infection
- Have chronic or recurrent bacterial or serious latent viral infection
- History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
- Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
Data sourced from ClinicalTrials.gov (NCT02504268) and the linked publication. 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. Informational only — not medical advice.