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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 30 Dec 2022

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At a glance

  • Drugs Abatacept (Primary) ; Adalimumab; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Biomarker
  • Acronyms Early AMPLE
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 14 Nov 2022 Results of an exploratory analysis assessing disease activity using serum samples from patients with early, seropositive RA treated with abatacept or adalimumab presented at the ACR Convergence 2022
    • 04 Jun 2022 Results of an analysis assessed the pharmacodynamics changes in response to treatment with abatacept or adalimumab, and to identify and differentiate the impact of each drug on modulation of immune cells at the molecular level presented at the 23rd Annual Congress of the European League Against Rheumatism
    • 18 Sep 2021 Results published in the Arthritis Research and Therapy
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