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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT00819585

Run by

Novartis Pharmaceuticals

People needed

432

Starts

2008-12-01

Expected to finish

2010-08-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 before any trial procedure is performed.
• Exclusion Criteria:
• Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
• Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• San Diego Arthritis & Osteoporosis Medical clinic — San Diego, California, United States
• Health Awareness — Jupiter, Florida, United States
• East-West Medical Research institute — Honolulu, Hawaii, United States
• Pinnacle Medical Research — Overland Park, Kansas, United States
• Cotton O'Neil Clinical Research Institute — Topeka, Kansas, United States
• Dolby Research, LLC — Baton Rouge, Louisiana, United States
• The Family Doctors — Shreveport, Louisiana, United States
• Shores Rheumatology — Saint Clair Shores, Michigan, United States
• Heartland Clinical Research, Inc. — Omaha, Nebraska, United States
• NM Clinical Research & Osteoporosis Ct. — Albuquerque, New Mexico, United States
• Rochester clinical Research — Rochester, New York, United States
• Health Research of Oklahoma, PLLC — Oklahoma City, Oklahoma, United States
• Castlerock Clinical Research Consultants, LLC — Tulsa, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Columbia Clinical Research — Columbia, South Carolina, United States
• Upstate Pharmaceutical Research — Greenville, South Carolina, United States
• MultiSpecialty Clinical Research — Johnson City, Tennessee, United States
• iMED Internal medicine, PA — San Antonio, Texas, United States
• Novartis Investigative site — Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative site — Rosario, Argentina
• Novartis Investigative Site — Gozée, Belgium
• Novartis Investigative site — Oostham, Belgium
• Novartis Investigative Site — Bacaramanga, Colombia
• Talbert Medical Group — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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