Long term study for participants completing SIRROUND-D and SIRROUND-T
Research type
Research Study
Full title
A Multicentre, Parallel-group Study of Long-term Safety and Efficacy of CNTO136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
IRAS ID
139277
Contact name
Adewale Adebajo
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2012-001176-10
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-TNFα 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 evaluate the long-term safety and effectiveness of CNTO 136 in patients with active RA who are resistant to DMARDs or anti-TNFα agents.
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, parallel group study of long term safety and efficacy of participants completing treatment in the CNTO136ARA3002 (SIRROUND-D) or CNTO136ARA3003 (SIRROUND-T) study. Participants will take part for between 1 and 5 years across the two studies.
Once the SIRROUND D & T studies have completely finished, this study will become open-label. Meaning the study doctor and participant will know which treatment group the participant is assigned to,
There are 2 treatment groups in this study:
1. Group 1 Higher dose (100 mg) of sirukumab injections every 2 weeks
2. Group 2 Lower dose (50 mg) of sirukumab injections every 4 weeksREC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0333
Date of REC Opinion
13 Dec 2013
REC opinion
Further Information Favourable Opinion