CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 enrolled
Drug / intervention
Sarilumab +5 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/NCT02373202
NCT02373202Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis

Sanofi·interventional·Posted Feb 26, 2015·Updated Jan 30, 2018

In Brief

A Phase 3 clinical trial evaluating Sarilumab, Sulfasalazine, and 4 other interventions for Rheumatoid Arthritis. Completed, enrolled 91 participants across 40 sites.

Detailed Summary

Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 26, 2015
Enrollment StartFeb 1, 2015
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Sarilumabdrug

Pharmaceutical form:solution

Sulfasalazinedrug

Pharmaceutical form: Tablet Route of administration: Oral

Leflunomidedrug

Pharmaceutical form: Tablet Route of administration: Oral

Bucillaminedrug

Pharmaceutical form: Tablet Route of administration: Oral

Tacrolimusdrug

Pharmaceutical form: Capsule Route of administration: Oral

Mizoribinedrug

Pharmaceutical form: Tablet Route of administration: Oral