Phase 4
Completed N=80
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02557100 ↗Enrolled (actual)
80
Serious AEs
4.5%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Adverse Events (AEs) — 55.0; 70.0; 57.9 Percentage of participant with AEs
◆ Published Evidence
Established
51citations · ~10 / year
HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA.
Summary
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
Linked Publications
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HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adverse Events (AEs) |
55.0; 70.0; 57.9 | — |
| PRIMARY Percentage of Participants With an Serious Adverse Events (SAEs) |
2.5; 5.0; 5.3 | — |
| PRIMARY Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc) |
0; 2.5; 0 | — |
| PRIMARY Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc) |
0; 2.5; 0 | — |
| PRIMARY Percentage of Drug Related Adverse Events (DRAEs) |
30.0; 27.5; 22.4 | — |
| PRIMARY Percentage of Drug Related Serious Adverse Events (DRSAEs) |
0; 2.5; 0 | — |
| PRIMARY Number of Deaths |
0; 1; 0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Symptoms of RA for no more than 12 months prior to enrollment
- Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA
- Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX 3X the upper limit of normal and positive rheumatoid factor
Exclusion Criteria
- History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)
- Prior use of non-biologic therapy other than methotrexate
- Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy
- Subjects with chronic or recent acute serious infection
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02557100) 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.