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

Status:	Active, not recruiting
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	12/6/2018
Start Date:	November 19, 2015
End Date:	April 5, 2019

A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

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.

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

We found this trial at

sites

Clinical and Translational Research Center of Alabama, PC

Tuscaloosa, Alabama 35406

Phone: 205-464-4711

from

Tuscaloosa, AL