CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 202 enrolled
Drug / intervention
sarilumab SAR153191 (REGN88) +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01768572
NCT01768572Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Jan 15, 2013·Updated Jun 26, 2017

In Brief

A Phase 3 clinical trial evaluating sarilumab SAR153191 (REGN88), tocilizumab, and 6 other interventions for Rheumatoid Arthritis. Completed, enrolled 202 participants across 78 sites in 19 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Belgium, Brazil, Czechia, Estonia, Finland, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartMar 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.5 years ago

Interventions

sarilumab SAR153191 (REGN88)drug

Pharmaceutical form: solution Route of administration: subcutaneous

tocilizumabdrug

Pharmaceutical form: solution Route of administration: intravenous

hydroxychloroquinedrug

Dispensed according to local practice.

methotrexatedrug

Dispensed according to local practice.

sulfasalazinedrug

Dispensed according to local practice.

leflunomidedrug

Dispensed according to local practice.

subcutaneous placebodrug

Pharmaceutical form: solution Route of administration: subcutaneous

intravenous placebodrug

Pharmaceutical form: solution Route of administration: intravenous