Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146652
Show 335 Study Locations
|Study Director:||Clinical Sciences and Operations||Sanofi|