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A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Jun 2024

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At a glance

  • Drugs Sarilumab (Primary) ; Folic acid; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms MOBILITY; RA-MOBILITY; SARIL-RA-MOBILITY
  • Sponsors Sanofi

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)
  • 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
  • 25 Aug 2022 Results of pooled post hoc analyses assessing clinical outcomes from three phase III trials: TARGET, MOBILITY, and MONARCH published in the Arthritis Research and Therapy

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