Clinical trial NCT02557100: Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Adverse Events (AEs)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Percentage of Participants With an Serious Adverse Events (SAEs)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Percentage of Drug Related Adverse Events (DRAEs)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Percentage of Drug Related Serious Adverse Events (DRSAEs)
timeFrame: up to 85 days post last dose, approximately 40 weeks
measure: Number of Deaths
timeFrame: up to 85 days post last dose, approximately 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinical And Translational Research Center Of Alabama, Pc
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Aurora
country: United States
facility: University Of Colorado Health Sciences Center
state: Colorado
city: Washington
country: United States
facility: Medical Faculty Associates,Inc.
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Marietta
country: United States
facility: Marietta Rheumatology
state: Georgia
city: Wheaton
country: United States
facility: The Center For Rheumatology And Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Grand Blanc
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Portland
country: United States
facility: Oregon Health & Science University (Ohsu)
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Arthritis Clinic Of Northern Virginia, P.C.
state: Virginia
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Med Prof Corp
state: Ontario
city: Windsor
country: Canada
facility: Essex County Medical Society
state: Ontario
city: Montreal
country: Canada
facility: Institut De Rhumatologie De Montreal
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Mexico City
country: Mexico
facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Mexico D.F.
country: Mexico
facility: Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Rigby W, Buckner JH, Louis Bridges S Jr, Nys M, Gao S, Polinsky M, Ray N, Bykerk V. HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA. Arthritis Res Ther. 2021 Sep 18;23(1):245. doi: 10.1186/s13075-021-02607-7.