SARIL-RA-ASCERTAIN - SFY13370 (CCRN 1085)
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY ASSESSING THE SAFETY AND TOLERABILITY OF SARILUMAB AND TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO ARE INADEQUATE RESPONDERS TO OR INTOLERANT OF TNF ANTAGONISTS
IRAS ID
125401
Contact name
Paul Emery
Contact email
Eudract number
2012-003536-23
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the safety of either 150 mg or 200 mg of sarilumab (or matching placebo) given by subcutaneous injection every other week together with tocilizumab (or placebo) given intravenously for up to 24 weeks. Tocilizumab or placebo will be given every 4 weeks at a starting dose of 4 mg/kg rising to 8 mg/kg , according to US prescribing instructions. Tocilizumab is an approved treatment for rheumatoid arthritis and is incorporated into this trial to provide further safety context.
Sarilumab belongs to a class of drugs called anti-Interleukin 6 Receptor monoclonal antibody (a type of protein) that blocks the activity of interleukin 6 in the body. Sarilumab is an investigational drug.
The study will include approximately 200 men and women at least 18 years of age and will be conducted worldwide. An individual participant will be in the study for approximately 9 months should all study activities be completed.
The study will comprise of a screening period of up to 4 weeks where the patients eligibility for the study will be assessed. Following this a treatment period of up to 24 weeks, to assess the effect of treatment with the study drug will take place. Finally, a post-treatment follow-up approximately 6-10 weeks from last drug administration will take place.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
13/LO/0499
Date of REC Opinion
21 May 2013
REC opinion
Further Information Favourable Opinion