Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
|ClinicalTrials.gov Identifier: NCT01146652|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2010
Last Update Posted : September 28, 2017
Assess the long term safety of sarilumab in patients with rheumatoid arthritis.
Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: SAR153191 (REGN88)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)|
|Actual Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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
- Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
- Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) [ Time Frame: Up to 264 weeks ]
- Disease Activity Score (DAS28-CRP) [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
- European League Against Rheumatism (EULAR) response [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146652
Show 335 Study Locations
|Study Director:||Clinical Sciences and Operations||Sanofi|