Status:
COMPLETED
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)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 chron...
Eligibility Criteria
Inclusion
- Core study
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT00819585
Start Date
December 1 2008
End Date
August 1 2010
Last Update
July 17 2018
Active Locations (89)
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1
Talbert Medical Group
Huntington Beach, California, United States, 92646
2
San Diego Arthritis & Osteoporosis Medical clinic
San Diego, California, United States
3
Health Awareness
Jupiter, Florida, United States, 33458
4
East-West Medical Research institute
Honolulu, Hawaii, United States, 96814