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

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02557100

Run by

Bristol-Myers Squibb

People needed

80

Starts

2015-11-19

Expected to finish

2019-03-28

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Rheumatology Associates Of North Alabama, P.C. — Huntsville, Alabama, United States
• Clinical And Translational Research Center Of Alabama, Pc — Tuscaloosa, Alabama, United States
• Arizona Arthritis & Rheumatology Research PLLC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research PLLC — Phoenix, Arizona, United States
• St. Joseph Heritage Medical Group — Fullerton, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• University Of Colorado Health Sciences Center — Aurora, Colorado, United States
• Medical Faculty Associates,Inc. — Washington D.C., District of Columbia, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Marietta Rheumatology — Marietta, Georgia, United States
• The Center For Rheumatology And Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Aa Mrc Llc — Grand Blanc, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Oregon Health & Science University (Ohsu) — Portland, Oregon, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Carolina Health Specialists — Myrtle Beach, South Carolina, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Arthritis Clinic Of Northern Virginia, P.C. — Arlington, Virginia, United States
• Dr. Anil K Gupta Med Prof Corp — Toronto, Ontario, Canada
• Essex County Medical Society — Windsor, Ontario, Canada
• Institut De Rhumatologie De Montreal — Montreal, Quebec, Canada
• Centre De Recherche Musculo-Squelettique — Trois-Rivières, Quebec, Canada

Full record on ClinicalTrials.gov

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