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NCT00819585 · ClinicalTrials.gov registry record · Phase 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)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 432
- Enrollment target
NCT00819585: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT00819585 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 432 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (225% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819585, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 432 participants
- Enrollment target
Study 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.
Primary Outcome
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Interventions
- DRUG Canakinumab
- DRUG Colchicine
- DRUG Allopurinol
- DRUG Placebo Matching Canakinumab
- DRUG Placebo Matching Colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00819585 record still lists
NCT00819585 is an interventional study that assigns participants to a tested intervention. The registered 432 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (225% higher).
The record links to 0 conditions, and to 5 interventions - of which Canakinumab is the first listed.
NCT00819585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00819585 about?
NCT00819585 is a clinical study titled "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)". 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...
What is the current status of trial NCT00819585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 432 participants. The study started on 2008-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00819585?
The interventions under investigation include: Canakinumab (DRUG), Colchicine (DRUG), Allopurinol (DRUG), Placebo Matching Canakinumab (DRUG), Placebo Matching Colchicine (DRUG).
Who is sponsoring clinical trial NCT00819585?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00819585's enrollment target sits among peer trials
432 90th of 2000 higher than 1,911 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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