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A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)

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Trial Profile

A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2024

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At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EXTEND; RA-EXTEND; SARIL-RA-EXTEND
  • Sponsors Sanofi; Sanofi Genzyme

    • Most Recent Events

    • 11 Jun 2024 According to a Regeneron Pharmaceuticals media release, company announced that U.S. FDA has approved Kevzara (sarilumab) for the treatment of patients with active polyarticular juvenile idiopathic arthritis based on evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJI (NCT01146652 , NCT01061736 & NCT02776735)
    • 02 Feb 2023 Results of two studies ( EXTEND and MONARCH OLE) assessing long-term safety and efficacy of sarilumab in rheumatoid arthritis patients, published in the Rheumatology.
    • 22 Nov 2022 Results of pooled analysis from (NCT01061736, NCT02332590, NCT01709578, NCT01146652) assessing disproportionate articular pain prevalence and effects of sarilumab published in the Rheumatology

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