A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Ini… (NCT00819585) | Clinical Trial Compass
CompletedPhase 2
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
United States432 participantsStarted 2008-12
Plain-language summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Who can participate
Age range18 Years – 80 Years
SexALL
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Core study
Inclusion Criteria:
* Signed written informed consent before any study procedure is performed.
* History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
* Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
* Body Mass Index (BMI) ≤ 40 kg/m\^2.
* Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped \> 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Exclusion Criteria:
* Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
* History of allergy or contraindication to colchicine or allopurinol.
* History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
* History of bone marrow suppression.
* Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
Extension study
Inclusion criteria:
* Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
* Patients who have signed a written informed consent bef…
What they're measuring
1
Core Study: Mean Number of Gout Flares Per Participant