A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy
Phase of Trial: Phase III
Latest Information Update: 16 Jun 2018
At a glance
- Drugs Sarilumab (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Acronyms SARIL-RA-EASY
- Sponsors Sanofi
- 16 Jun 2018 Long-term five year results from six clinical trials including this trial presented at the 19th Annual Congress of the European League Against Rheumatism.
- 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).
- 22 May 2017 According to a Sanofi media release, based on the data from approximately 2,900 adults the US FDA has approved Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs, such as methotrexate (MTX).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History