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

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ClinicalTrials.gov Identifier: NCT02557100
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Drug: Adalimumab Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abatacept in combination with methotrexate
Abatacept subcutaneous (SC) injection, 125 mg, weekly for 24 weeks. 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. Open-label Abatacept subcutaneous (SC) injection, 125 mg, weekly and maintain the enrollment dose of MTX unless toxicity or intolerability occurs during the study.
Drug: Abatacept
Other Name: Orencia

Drug: Methotrexate
Active Comparator: Adalimumab in combination with methotrexate
Adalimumab SC injection, 40 mg, once every two weeks for 24 weeks, 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. Open-label Abatacept subcutaneous (SC) injection, 125 mg, weekly and maintain the enrollment dose of MTX unless toxicity or intolerability occurs during the study.
Drug: Abatacept
Other Name: Orencia

Drug: Adalimumab
Other Name: Humira

Drug: Methotrexate



Primary Outcome Measures :
  1. Changes from baseline in levels of autoantibody levels (anti-CCP2 and ACPA) [ Time Frame: 24 weeks ]
  2. Efficacy of abatacept based on changes to cytokines (TNFa) [ Time Frame: 24 weeks ]
  3. Efficacy of abatacept based on changes to percentages of T-cell subsets [ Time Frame: 24 weeks ]
  4. Efficacy of abatacept based on changes to activation states of T-cell subsets [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557100


  Hide Study Locations
Locations
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United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294-7201
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
Clinical And Translational Research Center Of Alabama, Pc
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Arizona Arthritis & Rheumatology Research PLLC
Glendale, Arizona, United States, 85306
United States, California
St. Joseph Heritage Medical Group
Fullerton, California, United States, 92835
Desert Medical Advances
Palm Desert, California, United States, 92260
United States, Colorado
University Of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, District of Columbia
Medical Faculty Associates,Inc.
Washington, District of Columbia, United States, 20037
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States, 33324
United States, Georgia
Marietta Rheumatology
Marietta, Georgia, United States, 30060
United States, Maryland
The Center For Rheumatology And Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Michigan
Aa Mrc Llc
Grand Blanc, Michigan, United States, 98439
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Oregon
Oregon Health & Science University (Ohsu)
Portland, Oregon, United States, 97239
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635-8406
United States, South Carolina
Carolina Health Specialists
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Virginia
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
Algeria
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Algeria, 85037
Canada, Ontario
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada, M9V 4B4
Essex County Medical Society
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Institut De Rhumatologie De Montreal
Montreal, Quebec, Canada, H2L 1S6
Centre De Recherche Musculo-Squelettique
Trois-rivieres, Quebec, Canada, G8Z 1Y2
Mexico
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Distrito Federal, Mexico, 11850
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico, 44650
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Mexico D.F., Mexico, 06760
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02557100     History of Changes
Other Study ID Numbers: IM101-567
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Abatacept
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents