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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02557100
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abatacept — DRUG
  • Adalimumab — DRUG
  • Methotrexate — DRUG

Study Details

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.

Key Dates

Start date
Nov 19, 2015
Status verified
Aug 2020
Primary completion
Mar 28, 2019
Completion
Mar 28, 2019

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    Abatacept Single Blind Treatment Period
  • Active Comparator: Treatment B
    Adalimumab Single Blind Treatment Period
  • Active Comparator: Treatment C
    Abatacept Cumulative Treatment Period

Primary Outcome Measure

Percentage of Adverse Events (AEs) [ Time Frame: up to 85 days post last dose, approximately 40 weeks ]

Locations (21)

FacilityCityStateZIPSite coordinators
University Of Alabama At BirminghamBirminghamAlabama35294-7201-
Rheumatology Associates Of North Alabama, P.C.HuntsvilleAlabama35801-
Clinical And Translational Research Center Of Alabama, PcTuscaloosaAlabama35406-
Arizona Arthritis & Rheumatology Research PLLCGlendaleArizona85306-
Arizona Arthritis & Rheumatology Research PLLCPhoenixArizona85037-
St. Joseph Heritage Medical GroupFullertonCalifornia92835-
Desert Medical AdvancesPalm DesertCalifornia92260-
University Of Colorado Health Sciences CenterAuroraColorado80045-
Howard University HospitalWashington D.C.District of Columbia20060-
Medical Faculty Associates,Inc.Washington D.C.District of Columbia20037-
Integral Rheumatology & Immunology SpecialistsPlantationFlorida33324-
Marietta RheumatologyMariettaGeorgia30060-
The Center For Rheumatology And Bone ResearchWheatonMaryland20902-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
Aa Mrc LlcGrand BlancMichigan48439-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Oregon Health & Science University (Ohsu)PortlandOregon97239-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-8406-
Carolina Health SpecialistsMyrtle BeachSouth Carolina29572-
West Tennessee Research InstituteJacksonTennessee38305-
Arthritis Clinic Of Northern Virginia, P.C.ArlingtonVirginia22205-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University Of Alabama At Birmingham· Birmingham, ALRheumatology Associates Of North Alabama, P.C.· Huntsville, ALClinical And Translational Research Center Of Alabama, Pc· Tuscaloosa, ALArizona Arthritis & Rheumatology Research PLLC· Glendale, AZArizona Arthritis & Rheumatology Research PLLC· Phoenix, AZSt. Joseph Heritage Medical Group· Fullerton, CA

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