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A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

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Trial Profile

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jan 2024

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At a glance

  • Drugs Abatacept (Primary) ; Adalimumab
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPLE
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 15 Nov 2023 Results assessing the prevalence of anti-PAD2, anti-PAD3 and anti-PAD4 IgG and IgA in a cohort of established RA patients, and the impact of treatment on antibody (Ab) levels, in the adalimumab vs. abatacept head-to-head active RA AMPLE study, were presented at the ACR Convergence 2023.
  • 09 Nov 2021 Results (n=2087) of pooled analysis from 4 Randomized Controlled Trials (NCT00122382, NCT00929864, NCT01142726 and NCT02504268) assessing clinical outcomes among patients with SPEAR and non-SPEAR to understand the differential treatment impact of ABA on each ACR core measure, presented at the ACR Convergence 2021.
  • 09 Nov 2021 Results of pooled analysis from NCT00122382, NCT00929864, NCT01142726 and NCT02504268; comparing clinical outcomes of RA patients with enriched autoantibody biomarkers and early disease stage (SPEAR) to non-SPEAR, presented at the ACR Convergence 2021

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