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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 28, 2019

Interventions

  • Drug: Abatacept
  • Drug: Adalimumab
  • Drug: Methotrexate

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Adverse Events (AEs)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an AE
  • Percentage of Participants With an Serious Adverse Events (SAEs)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an SAEs
  • Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an (AEsDc)
  • Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an (SAEsDc)
  • Percentage of Drug Related Adverse Events (DRAEs)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an DRAEs
  • Percentage of Drug Related Serious Adverse Events (DRSAEs)
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Percentage of participants who experienced an DRSAEs
  • Number of Deaths
    • Time Frame: up to 85 days post last dose, approximately 40 weeks
    • Number of participants who experienced Death

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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