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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2017

At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions
  • Acronyms ABILITY; RA-EXTEND; SARIL-RA-EXTEND
  • 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 (n=Jul 2016, data cut off: Jul 2016) examining the effects of dose reduction of sarilumab 200 mg q2w to 150 mg q2w in patients from TARGET (NCT01709578) that occurred in EXTEND (NCT01146652) primarily for protocol-specified laboratory abnormalities presented at the 18th Annual Congress of the European League Against Rheumatism
    • 10 Jun 2017 Biomarkers information updated
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