A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

Phase 3

Completed

• Conditions: arthritis; rheumatoid arthritis; 10023213

• Registration Number: NL-OMON41668
• Lead Sponsor: Sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Patient with Rheumatoid Arthritis (RA) who was previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, or SFY13370 study

Exclusion Criteria

- Patient with any adverse event leading to permanent study drug discontinuation from a prior study.
- Treatment with any concurrent biologic agents including investigational drugs for the treatment of Rheumatoid Arthritis (RA)
- Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety assessment of sarilumab over time.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Proportion of patients who achieve ACR20, DAS28 remission and EULAR response<br /><br>over time;<br /><br>HAQ-Di results over time;</p><br>