Flare prevention study of canakinumab in patients with active SJIA

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations (original protocol, amendment 1, amendment 2, amendment 3)

• IRAS ID

  33593

• Contact name

  Patricia Woo

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-005479-82

• Clinicaltrials.gov Identifier

  NCT00889863

• 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 a antibody that works by binding to and neutralizing human IL-1 ǟ÷, a specialised protein (cytokine) 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 a earlier small study.This study of canakinumab has 2 parts. The purpose of Part I (open label part) of this study is to show the ability of patients with SJIA to taper from corticosteroid use while receiving canakinumab. The purpose of Part II (double blind part) is to show how effective canakinumab is in preventing SJIA flares. 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 - Harrow Research Ethics Committee

• REC reference

  09/H0714/64

• Date of REC Opinion

  16 Dec 2009

• REC opinion

  Favourable Opinion