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Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis - IM101-567

Updated:   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 4


  • Gender(s)

  • 18+

    Age Range

  • Recruiting

Treatment Options

Study Arms
Experimental: Abatacept in combination with methotrexate
Drug: Methotrexate Drug: Abatacept
Active Comparator: Adalimumab in combination with methotrexate
Drug: Methotrexate Drug: Adalimumab Drug: Abatacept

Key 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 < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses - At least 3 tender & 3 swollen joints - Anti-cyclic citrullinated peptide (CCP) > 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

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