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.

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.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Jul 2017

At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms MOBILITY; RA-MOBILITY; SARIL-RA-MOBILITY
  • Sponsors Sanofi
  • Most Recent Events

    • 27 Jun 2017 According to a Sanofi Genzyme media release, based on the data from seven Phase 3 trials in the global SARIL-RA clinical development program, the European Commission (EC) has granted marketing authorisation for Kevzara (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
    • 17 Jun 2017 Results assessing association between rs6742078 and bilirubin levels in Rheumatoid Arthritis patients treated with sarilumab, presented at the 18th Annual Congress of the European League Against Rheumatism.
    • 17 Jun 2017 Results of efficacy endpoint assessed in 3 studies (NCT01061736, NCT01709578 and NCT02332590) presented at the 18th Annual Congress of the European League Against Rheumatism
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