NCT02057250

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks. For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).

Conditions

• RA

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: Solution Route of administration: Subcutaneous
DEVICE	Auto-Injector Device (AID)
DEVICE	Pre-filled Syringe (PFS)
DRUG	Methotrexate	Dispensed according to local practice.
DRUG	Sulfasalazine	Dispensed according to local practice.
DRUG	Leflunomide	Dispensed according to local practice.
DRUG	Hydroxychloroquine	Dispensed according to local practice.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-02-01
• Completion: 2016-03-01
• First posted: 2014-02-07
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

53 sites across 6 countries: United States, Chile, Mexico, Poland, Russia, South Africa