ACZ885H2255 - Acute Gout

• Research type

  Research Study

• Full title

  An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine

• IRAS ID

  8346

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-004666-61

• ISRCTN Number

  Not available

• Research summary

  Gout is a disease in which there is an excess build-up of uric acid in the body, due to either overproduction or under excretion of uric acid by the kidney. In gout, the excess uric acid is deposited in joints, tendons and surrounding tissues and causes inflammation of these tissues. Gout most commonly attacks the joint of the big toe.Acute gouty attacks are painful and potentially disabling arthritis which needs immediate treatment.The optimal therapy is directed at controlling the pain and inflammation. Current treatments for acute attacks include non-steroidal anti-inflammatory drugs (NSAIDs), colchicine and corticosteroids.However, current treatments for acute gout attacks are not always effective in relieving the pain, well tolerated or may not be used in some patients as they may have other medical problemsGouty inflammation is due to urate crystal-induced release of proinflammatory cytokines, such as Interleukin-1?(IL-1×ý) from leukocytes.ACZ885 (the study drug) is a fully human monoclonal anti-human IL-1×ý antibody. It is designed to bind to human IL-1×ý and thus blocks the interaction of this cytokine with its receptors. The study drug is administered via an injection into either the arm or thigh.Patients need to have an acute gout attack in order to enter the study. Patients will be required to give their consent and will then undergo examinations to further determine their eligibility for the study. Patients who enter the study will have a 5 in 6 chance of receiving active study drug.Each patient will visit the surgery 5 times over an 8 week period. A patient??s participation in the study is expected to last 8 weeks.The study is being run by Novartis Pharma AG. Approximately 200 patients from across the world will be recruited into the study of which 10 patients will be recruited in the UK.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  08/H0904/105

• Date of REC Opinion

  28 Jan 2009

• REC opinion

  Further Information Favourable Opinion