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
Overview
- Phase
- Phase 4
- Intervention
- Methotrexate
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 80
- Locations
- 27
- Primary Endpoint
- Percentage of Participants With an Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment A
Abatacept Single Blind Treatment Period
Intervention: Methotrexate
Treatment B
Adalimumab Single Blind Treatment Period
Intervention: Abatacept
Treatment B
Adalimumab Single Blind Treatment Period
Intervention: Adalimumab
Treatment A
Abatacept Single Blind Treatment Period
Intervention: Abatacept
Treatment B
Adalimumab Single Blind Treatment Period
Intervention: Methotrexate
Treatment C
Abatacept Cumulative Treatment Period
Intervention: Abatacept
Outcomes
Primary Outcomes
Percentage of Participants With an Serious Adverse Events (SAEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an SAEs
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (AEsDc)
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRAEs
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRSAEs
Number of Deaths
Time Frame: up to 85 days post last dose, approximately 40 weeks
Number of participants who experienced Death
Percentage of Adverse Events (AEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an AE