Study of canakinumab in patients with active SJIA

• Research type

  Research Study

• Full title

  An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab(ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA).

• IRAS ID

  120307

• Contact name

  Athimalaipet V Ramanan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-003054-92

• Research summary

  Systemic juvenile idiopathic arthritis (SJIA) is the most common form of persistent arthritis in children. Affected children may develop flu like 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 nonsteroidal anti-inflammatory drugs (NSAID), corticosteroids, and methotrexate. The medication being studied is an antibody called 'Canakinumab' that works by binding to and neutralizing human IL1 ß, a specialized protein recognised 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 earlier studies. This extension study will look at the long term data with repeated dosing of canakinumab in patients with SJIA. In addition, the effect of canakinumab on vaccination with certain types of vaccines, called 'inactivated vaccines' will be assessed. 5 sites in the UK are expected to take part with a target of around 19 patients in total to be entered.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  13/SW/0034

• Date of REC Opinion

  25 Mar 2013

• REC opinion

  Further Information Favourable Opinion