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A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists
Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 202 |
| Start date | 2013-03 |
| Completion | 2014-10 |
Conditions
- Rheumatoid Arthritis
Interventions
- sarilumab SAR153191 (REGN88)
- tocilizumab
- hydroxychloroquine
- methotrexate
- sulfasalazine
- leflunomide
- subcutaneous placebo
- intravenous placebo
Primary outcomes
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to 211 days
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.
Countries
United States, Argentina, Belgium, Brazil, Czechia, Estonia, Finland, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, United Kingdom