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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Adalimumab; Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02557100

IM101-567

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

Treatment A

Experimental group

Description:

Abatacept Single Blind Treatment Period

Treatment:

Drug: Methotrexate

Drug: Abatacept

Treatment B

Active Comparator group

Description:

Adalimumab Single Blind Treatment Period

Treatment:

Drug: Methotrexate

Drug: Abatacept

Drug: Adalimumab

Treatment C

Active Comparator group

Description:

Abatacept Cumulative Treatment Period

Treatment:

Drug: Abatacept