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

NCT02057250 ↗

Phase 3 Completed 217 enrolled Sanofi Regeneron Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2014-03
Primary completion: 2015-02
Completion: 2016-03

Publications

Kivitz A, Baret-Cormel L, van Hoogstraten H, Wang S, Parrino J, Xu C, Stanislav M. Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients with Active Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sarilumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Sarilumab	Monoclonal antibody	200 mg	Subcutaneous
Background	Hydroxychloroquine	Small molecule	—	—
Background	Leflunomide	Small molecule	—	—
Background	Methotrexate	Small molecule	—	—
Background	Sulfasalazine	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications