NCT00819585|CompletedPhase 2Results

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

Novartis Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

CACZ885H2251EudraCT : 2008-005876-28

Study Type

interventional

Target

432

Locations

18 countries

Sites

Timeline

RegisteredJan 2009

StartedDec 2008

CompletionAug 2010

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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

432

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2008

Geographic Reach

18 countries

89 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed

9 months until next milestone

Results Posted

Study results publicly available

May 6, 2011

Completed

Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

January 8, 2009

Results QC Date

February 28, 2011

Last Update Submit

June 19, 2018

Conditions

Gout

Keywords

GoutChronic goutGouty arthritisGout flares

Outcome Measures

Primary Outcomes (1)

Core Study: Mean Number of Gout Flares Per Participant
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Baseline of the core study to Week 16

Secondary Outcomes (11)

Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
up to 16 weeks after randomization
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
Baseline of the core study to Week 16
Core Study: Percentage of Participants With Gout Flare at Different Time Points
Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Baseline of the core study to Week 16
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Baseline of the core study to Week 16
+6 more secondary outcomes

Study Arms (11)

Core study: Canakinumab 25 mg

EXPERIMENTAL

Canakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.