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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment A	Methotrexate	Abatacept Single Blind Treatment Period
Treatment B	Methotrexate	Adalimumab Single Blind Treatment Period
Treatment A	Abatacept	Abatacept Single Blind Treatment Period
Treatment B	Abatacept	Adalimumab Single Blind Treatment Period
Treatment B	Adalimumab	Adalimumab Single Blind Treatment Period
Treatment C	Abatacept	Abatacept Cumulative Treatment Period

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Serious Adverse Events (SAEs)	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)	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)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)	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)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an DRSAEs
Number of Deaths	up to 85 days post last dose, approximately 40 weeks	Number of participants who experienced Death
Percentage of Adverse Events (AEs)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an AE

Secondary Outcome Measures

Name	Time	Method

Locations (27): 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
🇺🇸
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, District of Columbia, United States
Howard University Hospital
🇺🇸
Washington, District of Columbia, United States
Integral Rheumatology & Immunology Specialists
🇺🇸
Plantation, Florida, United States
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University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States