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)
Public ClinicalTrials.gov record NCT00819585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00819585
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 432 participants
Conditions and interventions
Conditions
Interventions
- Canakinumab Drug
- Colchicine Drug
- Allopurinol Drug
- Placebo Matching Canakinumab Drug
- Placebo Matching Colchicine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2008 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Aug 2010 (Actual)
- Last update posted
- Jul 17, 2018
2008 – 2010
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Talbert Medical Group | Huntington Beach | California | 92646 | — |
| San Diego Arthritis & Osteoporosis Medical clinic | San Diego | California | — | — |
| Health Awareness | Jupiter | Florida | 33458 | — |
| East-West Medical Research institute | Honolulu | Hawaii | 96814 | — |
| Pinnacle Medical Research | Overland Park | Kansas | 66215 | — |
| Cotton O'Neil Clinical Research Institute | Topeka | Kansas | — | — |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | — |
| The Family Doctors | Shreveport | Louisiana | 71115 | — |
| Shores Rheumatology | Saint Clair Shores | Michigan | 48081 | — |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | — | — |
| NM Clinical Research & Osteoporosis Ct. | Albuquerque | New Mexico | — | — |
| Rochester clinical Research | Rochester | New York | 14609 | — |
| Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Castlerock Clinical Research Consultants, LLC | Tulsa | Oklahoma | 74136 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Columbia Clinical Research | Columbia | South Carolina | 29201 | — |
| Upstate Pharmaceutical Research | Greenville | South Carolina | 29615 | — |
| MultiSpecialty Clinical Research | Johnson City | Tennessee | — | — |
| iMED Internal medicine, PA | San Antonio | Texas | 78228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00819585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00819585 live on ClinicalTrials.gov.