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

• Status: Completed
• Trial end date: 2019-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Adalimumab; Antirheumatic Agents; Methotrexate

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