Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment sar153191 (regn88)
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date June 2010
End date December 2020
Trial size 2000 participants
Trial identifier NCT01146652, 2010-019262-86, LTS11210

Summary

Primary Objective:

Assess the long term safety of sarilumab in patients with rheumatoid arthritis.

Secondary Objective:

Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sarilumab (SAR153191), Disease Modifying Anti-Rheumatic Drug (DMARD) therapy as required in the initial protocol.
sar153191 (regn88)
Pharmaceutical form: solution Route of administration: subcutaneous

Primary Outcomes

Measure
Number of patients with adverse events
time frame: At least 264 weeks or until commercial availability whichever later but no later than 2020

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria : Patients with Rheumatoid Arthritis (RA) who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, or EFC13752 study. Exclusion criteria: Patients with any adverse event leading to permanent study drug discontinuation from a prior study. Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Sanofi.