Status:
COMPLETED
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participa...
Detailed Description
The maximum duration of the study was 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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Main study:
- Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.
- Sub-study:
- Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.
- Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.
- Exclusion criteria:
- Main study:
- Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.
- Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.
- Sub-study: There are no additional exclusion criteria to those defined in main study.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
2023 Patients enrolled
Trial Details
Trial ID
NCT01146652
Start Date
June 21 2010
End Date
December 31 2020
Last Update
March 28 2022
Active Locations (335)
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1
Investigational Site Number 840070
Anniston, Alabama, United States, 36207
2
Investigational Site Number 840138
Birmingham, Alabama, United States, 35205
3
Investigational Site Number 840152
Huntsville, Alabama, United States, 35801
4
Investigational Site Number 840072
Gilbert, Arizona, United States, 85234