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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

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE November 19, 2015
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Changes from baseline in levels of autoantibody levels (anti-CCP2 and ACPA) [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to cytokines (TNFa) [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to percentages of T-cell subsets [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to activation states of T-cell subsets [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Efficacy of abatacept based on changes to autoantibody levels [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to cytokines [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to percentages of immune cell subsets [ Time Frame: 24 weeks ]
  • Efficacy of abatacept based on changes to activation states of immune cell subsets [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT02557100 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Abatacept
    Other Name: Orencia
  • Drug: Adalimumab
    Other Name: Humira
  • Drug: Methotrexate
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Abatacept
    • 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.
    Interventions:
    • Drug: Abatacept
    • Drug: Adalimumab
    • Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2018)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
50
Actual Study Completion Date  ICMJE March 28, 2019
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Algeria,   Canada,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557100
Other Study ID Numbers  ICMJE IM101-567
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP