Trials / Completed
CompletedNCT00819585
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)
A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 432 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Canakinumab | Canakinumab was supplied in glass vials as a lyophilized powder. |
| DRUG | Colchicine | 0.5 mg capsule orally once daily for 16 weeks. |
| DRUG | Allopurinol | 100-300 mg orally once daily for 24 weeks. |
| DRUG | Placebo Matching Canakinumab | Subcutaneous injection. |
| DRUG | Placebo Matching Colchicine | Capsule orally once daily for 16 weeks. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-08-01
- Completion
- 2010-08-01
- First posted
- 2009-01-09
- Last updated
- 2018-07-17
- Results posted
- 2011-05-06
Locations
89 sites across 18 countries: United States, Argentina, Belgium, Colombia, Czechia, Germany, Guatemala, Hungary, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00819585. Inclusion in this directory is not an endorsement.