Open-label extension study of canakinumab in patients with SJIA
Research type
Research Study
Full title
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations
IRAS ID
37393
Contact name
Patricia Woo, CBE
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-008008-42
Clinicaltrials.gov Identifier
Research summary
Systemic juvenile idiopathic arthritis (SJIA) is the most common form of persistent arthritis in children. Affected children may develoflulike symptoms including a intermittent fever, a faint rash, lethargy, reduced physical activity, and poor appetite. Ultimately, all patients will develop swelling and pain of some joints (arthritis). The disease symptoms often flare, meaning they come and go. Late effects can include stiff or bent joints and joint damage. In addition, internal organs may be involved and that can lead to inflammation of the organ and or it's surrounding membrane (serositis). Possible treatments for SJIA include non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, and methotrexate.Canakinumab is an antibody that works by binding to and neutralizing human IL-1 B, a specialized protein (cytokine) recognized as a main factor involved in a variety of inflammatory conditions, including SJIA. It was shown to be an effective treatment in such patients in a earlier small study. This extension study will study the long-term effectiveness and safety of repeated dosing of canakinumab to patients with SJIA who had demonstrated a good clinical response with treatment in at least 1 of 2 other ongoing studies (CACZ885G2305 and CACZ885G2301). This is an open label study, meaning all patients will receive canakinumab and none will receive placebo. Patients will continue to receive canakinumab to treat their SJIA as long as the treatment maintains a good clinical response and no safety issues are observed.
REC name
London - Harrow Research Ethics Committee
REC reference
09/H0714/65
Date of REC Opinion
16 Dec 2009
REC opinion
Favourable Opinion