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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept; Drug: Methotrexate; Drug: Adalimumab

• Registration Number: NCT02557100
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2015-11-19
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Results First Submitted: 2020-04-20
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (27)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Clinica de Investigacion en Reumatologia y Obesidad S.C.; 🇲🇽 Guadalajara, Jalisco, Mexico

Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.; 🇲🇽 Mexico D.F., Mexico

Integral Rheumatology & Immunology Specialists; 🇺🇸 Plantation, Florida, United States

Aa Mrc Llc; 🇺🇸 Grand Blanc, Michigan, United States

St. Joseph Heritage Medical Group; 🇺🇸 Fullerton, California, United States

Dr. Anil K Gupta Med Prof Corp; 🇨🇦 Toronto, Ontario, Canada

Desert Medical Advances; 🇺🇸 Palm Desert, California, United States

The Center For Rheumatology And Bone Research; 🇺🇸 Wheaton, Maryland, United States

University Of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Oregon Health & Science University (Ohsu); 🇺🇸 Portland, Oregon, United States

Clinical And Translational Research Center Of Alabama, Pc; 🇺🇸 Tuscaloosa, Alabama, United States

Centre De Recherche Musculo-Squelettique; 🇨🇦 Trois-rivieres, Quebec, Canada

Rheumatology Associates Of North Alabama, P.C.; 🇺🇸 Huntsville, Alabama, United States

Medical Faculty Associates,Inc.; 🇺🇸 Washington, District of Columbia, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States

Marietta Rheumatology; 🇺🇸 Marietta, Georgia, United States

Clinical Pharmacology Study Group; 🇺🇸 Worcester, Massachusetts, United States

West Tennessee Research Institute; 🇺🇸 Jackson, Tennessee, United States

CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.; 🇲🇽 Mexico City, Distrito Federal, Mexico

Institut De Rhumatologie De Montreal; 🇨🇦 Montreal, Quebec, Canada

Arizona Arthritis & Rheumatology Research PLLC; 🇺🇸 Phoenix, Arizona, United States

Arthritis Clinic Of Northern Virginia, P.C.; 🇺🇸 Arlington, Virginia, United States

Carolina Health Specialists; 🇺🇸 Myrtle Beach, South Carolina, United States

University Of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Essex County Medical Society; 🇨🇦 Windsor, Ontario, Canada

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States