Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:June 2010
End Date:December 2020

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A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)

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.

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.

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.
We found this trial at
78
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