Sirukumab in Participants with Active RA Despite Anti-TNF Therapy
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF Therapy
IRAS ID
105971
Contact name
Adewale Adebajo
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2010-022243-38
Clinicaltrials.gov Identifier
Research summary
Rheumatoid arthritis (RA) is a long-lasting (chronic) inflammatory disease affecting many joints throughout the body, resulting in pain, swelling and joint damage with deformity which gets worse over time, causing loss of function and disability. Conventional therapies consist of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and disease-modifying anti-rheumatic drugs (DMARDs) including Anti-TNFa therapy, all of which are associated with varying degrees of effectiveness. Biologic therapies represent treatment that eases the signs and symptoms of RA by targeting a key inflammatory molecule. CNTO 136 (sirukumab) is a human anti-interleukin-6 (IL-6) mAb developed by Janssen Research & Development in collaboration with GlaxoSmithKline. It binds to human IL-6 associated with high affinity and specificity, and has been shown to inhibit the biological effect of IL-6. This research study is being done to see if the drug is effective in reducing the signs and symptoms of patients with active RA who are resistant to an anti-TNFa agent and to assess the safety of the treatment. Sirukumab is not approved by the US Food and Drug Administration (FDA) or the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency ?? MHRA, as a treatment for any disease and is not commercially available in any country. This is a multicentre, randomised, placebo-controlled, parallel group study. There are 3 treatment groups in this study: 1. Group 1 Placebo injections every 2 weeks (330 participants) 2. Group 2 Higher dose (100 mg) of sirukumab injections every 2 weeks (330 participants) 3. Group 3 Lower dose (50 mg) of sirukumab injections every 4 weeks(330 participants)
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
12/YH/0446
Date of REC Opinion
21 Nov 2012
REC opinion
Further Information Favourable Opinion