Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in RA
Research type
Research Study
Full title
A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis.
IRAS ID
168058
Contact name
Monique de Weger
Contact email
Sponsor organisation
sanofi-aventis recherche & developpement
Eudract number
2014-002541-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 5 days
Research summary
The purpose of this study is to assess the efficacy of 200 mg of sarilumab versus adalimumab 40 mg when given to rheumatoid arthritis (RA) patients, and to provide data to support using sarilumab as single therapy for patients who are either intolerant of, considered inappropriate candidates for continued treatment, or inadequate responders to the first-line drug methotrexate (MTX).
Adalimumab is a widely used TNF-inhibiting anti-inflammatory drug, already licenced for RA. Sarilumab is an investigational drug that belongs to a class of drugs called anti-Interleukin 6 receptor monoclonal antibody (a type of protein) which blocks the activity of interleukin 6 in the body.
The study will approx 340 patients worldwide. Total study duration per patient is expected to be up to 58 weeks.
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 24 weeks where patients receive either sarilumab or adalimumab as subcutaneous injections (with matching placebo) every 2 weeks, followed then by a 24 week period where all patients received sarilumab every 2 weeks. Finally, a post treatment follow up approximately 6 weeks from last drug administration will take place.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/0145
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion