CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
Sarilumab SAR153191 (REGN88) +3 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/NCT02293902
NCT02293902Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Sanofi·interventional·Posted Nov 19, 2014·Updated Jan 30, 2018

In Brief

A Phase 3 clinical trial evaluating Sarilumab SAR153191 (REGN88), Placebo (for sarilumab), and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 243 participants across 96 sites.

Detailed Summary

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. Secondary Objective: -To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 19, 2014
Enrollment StartNov 1, 2014
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago

Interventions

Sarilumab SAR153191 (REGN88)drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo (for sarilumab)other

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Methotrexatedrug

Dispensed according to local practice.

Folic aciddrug

Dispensed according to local practice.