Rheumatoid Arthritis Clinical Trial
Official title:
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
Primary Objective:
To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA)
patients.
Secondary Objective:
To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus
prefilled syringes (PFS).
Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase 12 weeks,
extension phase 52 weeks, post-treatment follow-up of 6 weeks.
For patients not entering the extension phase, total study duration up to 22 weeks
(screening, AID assessment phase and follow-up).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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