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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Abatacept
* Drug: Adalimumab
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Abatacept Single Blind Treatment Period | Drug: Abatacept<br> <br> * Other names: Orencia;Drug: Methotrexate<br> <br> |
| Active Comparator: Treatment B<br>Adalimumab Single Blind Treatment Period | Drug: Abatacept<br> <br> * Other names: Orencia;Drug: Adalimumab<br> <br> * Other names: Humira;Drug: Methotrexate<br> <br> |
| Active Comparator: Treatment C<br>Abatacept Cumulative Treatment Period | Drug: Abatacept<br> <br> * Other names: Orencia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Adverse Events (AEs) | Percentage of participants who experienced an AE | up to 85 days post last dose, approximately 40 weeks | 
| Percentage of Participants With an Serious Adverse Events (SAEs) | Percentage of participants who experienced an SAEs | up to 85 days post last dose, approximately 40 weeks | 
| Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc) | Percentage of participants who experienced an (AEsDc) | up to 85 days post last dose, approximately 40 weeks | 
| Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc) | Percentage of participants who experienced an (SAEsDc) | up to 85 days post last dose, approximately 40 weeks | 
| Percentage of Drug Related Adverse Events (DRAEs) | Percentage of participants who experienced an DRAEs | up to 85 days post last dose, approximately 40 weeks | 
| Percentage of Drug Related Serious Adverse Events (DRSAEs) | Percentage of participants who experienced an DRSAEs | up to 85 days post last dose, approximately 40 weeks | 
| Number of Deaths | Number of participants who experienced Death | up to 85 days post last dose, approximately 40 weeks |