Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
NCT ID: NCT02557100
Last Updated: 2020-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2015-11-19
2019-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Treatment A
Abatacept Single Blind Treatment Period
Abatacept
Methotrexate
Treatment B
Adalimumab Single Blind Treatment Period
Abatacept
Adalimumab
Methotrexate
Treatment C
Abatacept Cumulative Treatment Period
Abatacept
Interventions
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Abatacept
Adalimumab
Methotrexate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Glendale, Arizona, 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 D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Marietta Rheumatology
Marietta, Georgia, United States
The Center For Rheumatology And Bone Research
Wheaton, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Aa Mrc Llc
Grand Blanc, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Oregon Health & Science University (Ohsu)
Portland, Oregon, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada
Essex County Medical Society
Windsor, Ontario, Canada
Institut De Rhumatologie De Montreal
Montreal, Quebec, Canada
Centre De Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Mexico City, Mexico
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM101-567
Identifier Type: -
Identifier Source: org_study_id
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