ACZ885H2251 Extension study in pts given ACZ885 at time of acute flare

• Research type

  Research Study

• Full title

  A 24-week, open-label, multicentre, follow-up and extension study to CACZ885H2251, to assess safety, tolerability and efficacy of canakinumab (ACZ885) in patients with gout who are given canakinumab at the time of acute flare.

• IRAS ID

  26727

• Contact name

  James Warburton

• Eudract number

  2009-012316-40

• ISRCTN Number

  NA

• Research summary

  Gout is a disease caused by excess uric acid in the body; this excess is deposited in joints, tendons and surrounding tissues which causes inflammation of the tissues. Acute gout attacks are painful and require immediate treatment, ACZ885 maybe a potential alternative treatment option for these acute flares. This study is a 6 month safety extension for participants completing the core ACZ885H2251 study. Each participant who completes the core study and provides written informed consent will enter the extension study and be provided with the option to treat any acute flare of gout on demand with ACZ885 150mg injection given just under the skin. The study has 2 scheduled visits with the option for unscheduled flare visits and control visits (1 week after flare visit). Participants who experience an acute flare should seek immediate treatment with ACZ885 by visiting their study centre as soon as possible.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/43

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion