Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-26 @ 12:43 PM
Study NCT ID:
NCT02057250
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARIL-RA-EASY
Brief 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).
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).
For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: