Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Assess the long term safety of sarilumab in patients with rheumatoid arthritis.
Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)|
- Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: Yes ]
- Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) [ Time Frame: Up to 264 weeks ] [ Designated as safety issue: No ]
- Disease Activity Score (DAS28-CRP) [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: No ]
- European League Against Rheumatism (EULAR) response [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Experimental: Extension study
Sarilumab (SAR153191), Disease Modifying Anti-Rheumatic Drug (DMARD) therapy as required in the initial protocol.
Drug: SAR153191 (REGN88)
Pharmaceutical form: solution
Route of administration: subcutaneous
The maximum duration of the study may be up to 523 weeks:
- Up to 1-week of screening, if any
- At least 264 weeks of open label treatment phase and up to 516 weeks as maximum
- 6-week post-treatment follow-up as required per protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146652
Show 335 Study Locations
|Study Director:||Clinical Sciences and Operations||Sanofi|