CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 217 enrolled
Drug / intervention
Sarilumab +6 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/NCT02057250
NCT02057250Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Sanofi·interventional·Posted Feb 7, 2014·Updated Jun 20, 2017

In Brief

A Phase 3 clinical trial evaluating Sarilumab, Auto-Injector Device (AID), and 5 other interventions for RA. Completed, enrolled 217 participants across 53 sites in 6 countries.

Detailed Summary

Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRA
CountriesChile, Mexico, Poland, Russia, South Africa, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2014
Enrollment StartMar 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.4 years ago

Interventions

Sarilumabdrug

Pharmaceutical form: Solution Route of administration: Subcutaneous

Auto-Injector Device (AID)device

Pre-filled Syringe (PFS)device

Methotrexatedrug

Dispensed according to local practice.

Sulfasalazinedrug

Dispensed according to local practice.

Leflunomidedrug

Dispensed according to local practice.

Hydroxychloroquinedrug

Dispensed according to local practice.