CACZ885H2251 - Chronic Gout

• Research type

  Research Study

• Full title

  A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy

• IRAS ID

  13646

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-005876-28

• ISRCTN Number

  n/a

• Research summary

  Gout is a disease caused by an excess build-up of uric acid in the body, due to either overproduction or under excretion of uric acid by the kidney. The excess uric acid deposits as monosodium urate crystals in joints, tendons and surrounding tissues and causes inflammation of these tissues. Acute gout attacks are painful and require immediate treatment. A major goal in managing gout is long term reduction of uric acid, allopurinol being the most commonly prescribed medication.When patients start allopurinol treatment, some tend to have gout flares, therefore colchicine is commonly given to help treat the gout flare or prevent the gout flare from occurring. However, colchicine is often not well tolerated. Side effects can include diarrhoea, abdominal cramps, nausea and vomiting, and very rarely bone marrow suppression, myopathy and neuropathy. ACZ885 (the study drug) may be a potential alternative treatment option for patients with chronic gout who have started treatment with allopurinol.ACZ885 is a fully human monoclonal IL-1 antibody. It is designed to decrease the action of a protein in the body called IL-1beta. Excessive IL-1beta is involved in many different kinds of inflammatory diseases including gout. ACZ885 is administered via an injection into either the arm or thigh.Each patient who signs consent and meets all of the inclusion criteria will undergo examinations to determine that they are eligible to join the study. Patients who enter the study will have a 6 in 8 chance of receiving active study drug.Each patient will visit the surgery 9 times over a 26 week period. A patient??s participation in the study is expected to last 26 weeks.The study is being run by Novartis Pharma AG. Approximately 440 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

  09/H0904/10

• Date of REC Opinion

  1 Apr 2009

• REC opinion

  Further Information Favourable Opinion