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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)

NCT00819585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2018-07-17

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Argentina
  • Belgium
  • Colombia
  • Czechia
  • Germany
  • Guatemala
  • Hungary
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819585 on ClinicalTrials.gov