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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557100
• Other study ID #: IM101-567
• Status: Completed
• Phase: Phase 4
• Start date: November 19, 2015
• Est. completion date: March 28, 2019

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

• Adalimumab

• Methotrexate

Locations

Country	Name	City	State
Canada	Institut De Rhumatologie De Montreal	Montreal	Quebec
Canada	Dr. Anil K Gupta Med Prof Corp	Toronto	Ontario
Canada	Centre De Recherche Musculo-Squelettique	Trois-rivieres	Quebec
Canada	Essex County Medical Society	Windsor	Ontario
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C.	Guadalajara	Jalisco
Mexico	CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.	Mexico City	Distrito Federal
Mexico	Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.	Mexico D.F.
United States	Arthritis Clinic Of Northern Virginia, P.C.	Arlington	Virginia
United States	University Of Colorado Health Sciences Center	Aurora	Colorado
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	St. Joseph Heritage Medical Group	Fullerton	California
United States	Arizona Arthritis & Rheumatology Research PLLC	Glendale	Arizona
United States	Aa Mrc Llc	Grand Blanc	Michigan
United States	Rheumatology Associates Of North Alabama, P.C.	Huntsville	Alabama
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Marietta Rheumatology	Marietta	Georgia
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Desert Medical Advances	Palm Desert	California
United States	Arizona Arthritis & Rheumatology Research PLLC	Phoenix	Arizona
United States	Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	Oregon Health & Science University (Ohsu)	Portland	Oregon
United States	Clinical And Translational Research Center Of Alabama, Pc	Tuscaloosa	Alabama
United States	Howard University Hospital	Washington	District of Columbia
United States	Medical Faculty Associates,Inc.	Washington	District of Columbia
United States	The Center For Rheumatology And Bone Research	Wheaton	Maryland
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Adverse Events (AEs)	Percentage of participants who experienced an AE	up to 85 days post last dose, approximately 40 weeks
Primary	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
Primary	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
Primary	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
Primary	Percentage of Drug Related Adverse Events (DRAEs)	Percentage of participants who experienced an DRAEs	up to 85 days post last dose, approximately 40 weeks
Primary	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
Primary	Number of Deaths	Number of participants who experienced Death	up to 85 days post last dose, approximately 40 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form