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Trial ID IM101-863  |   NCT04909801

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
    1. Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
      1. Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
        1. Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
          1. At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
            1. At least 3 tender and at least 3 swollen joints at screening and at randomization

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Women who are breastfeeding
                1. Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
                  1. History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
                    1. At risk for tuberculosis
                      1. Recent acute infection
                        1. History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
                          1. History of infection of a joint prosthesis or artificial joint
                            1. History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
                              1. History of primary immunodeficiency
                                1. Current clinical findings or a history of a demyelinating disorder
                                  1. 5 or more joints cannot be assessed for tenderness or swelling Other protocol-defined inclusion/exclusion criteria apply
                                    Additional Information *

                                    Treatment Options

                                    Study Arms

                                    ASSIGNED INTERVENTION

                                    Study Arms

                                    Experimental: Arm 1: Abatacept + Methotrexate

                                    ASSIGNED INTERVENTION
                                    • Drug: Abatacept, Methotrexate

                                    Study Arms

                                    Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

                                    ASSIGNED INTERVENTION
                                    • Drug: Abatacept, Adalimumab, Methotrexate

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