CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,023 enrolled
Drug / intervention
SAR153191 (REGN88)drug
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/NCT01146652
NCT01146652Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Jun 17, 2010·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating SAR153191 (REGN88) for Rheumatoid Arthritis. Completed, enrolled 2,023 participants across 335 sites in 40 countries.

Detailed Summary

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Ecuador, Estonia, Finland, Germany, Greece, Guatemala, Hungary, Israel, Italy, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2010
Enrollment StartJun 21, 2010
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 16.0 years ago

Interventions

SAR153191 (REGN88)drug

Pharmaceutical form: solution Route of administration: subcutaneous