Phase 4
N=80
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02557100 ↗Enrolled (actual)
80
Serious AEs
4.5%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Adverse Events (AEs) — 55.0; 70.0; 57.9 Percentage of participant with AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Abatacept (Drug); Adalimumab (Drug); Methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2019
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 | — |
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.
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). 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.