Single-dose study of canakinumab in patients with active SJIA

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Paediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

• IRAS ID

  37810

• Contact name

  Patricia Woo

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-005476-27

• Clinicaltrials.gov Identifier

  NCT00886769

• Research summary

  Systemic juvenile idiopathic arthritis (SJIA) is the most common form of persistent arthritis in children. Affected children may develoflulike symptoms including an 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 its 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 neutralising human IL-1 ǟ÷, a specialised 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 an earlier small study. This study is a short 4-week study to look at the initial efficacy of canakinumab in patients with SJIA. Improvement in patients SJIA symptoms will be defined as an adapted ACR Paediatric Response 30 and above (the ACR Paediatric Response is a standardised scoring system developed by the American College of Rheumatology and is used to assess patients disease severity).

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  09/H0713/72

• Date of REC Opinion

  8 Mar 2010

• REC opinion

  Further Information Favourable Opinion