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Xanthine Oxidase Inhibitor

Extension study: Group C for Gout

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 15, 29, 57, 85, 113, and 141 of the core study

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

Eligible Conditions

Gout

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 15, 29, 57, 85, 113, and 141 of the core study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 15, 29, 57, 85, 113, and 141 of the core study

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 15, 29, 57, 85, 113, and 141 of the core study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core Study: Mean Number of Gout Flares Per Participant

Secondary study objectives

Gout

Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares

Core Study: Percentage of Participants With Gout Flare at Different Time Points

+7 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Group I: Extension study: Group DExperimental Treatment1 Intervention

Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.

Group II: Extension study: Group CExperimental Treatment2 Interventions

Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Group III: Extension study: Group BExperimental Treatment1 Intervention

Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.

Group IV: Extension study: Group AExperimental Treatment1 Intervention

Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Group V: Core study: Canakinumab q4wkExperimental Treatment3 Interventions

Canakinumab 50 mg sc at Days 1, and 29 followed by canakinumab 25 mg sc on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). 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.

Group VI: Core study: Canakinumab 50 mgExperimental Treatment4 Interventions

Canakinumab 50 mg 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.

Group VII: Core study: Canakinumab 300 mgExperimental Treatment4 Interventions

Canakinumab 300 mg 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.

Group VIII: Core study: Canakinumab 25 mgExperimental Treatment4 Interventions

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.

Group IX: Core study: Canakinumab 200 mgExperimental Treatment4 Interventions

Canakinumab 100 mg 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.

Group X: Core study: Canakinumab 100 mgExperimental Treatment4 Interventions

Group XI: Core study: Colchicine 0.5 mgActive Control3 Interventions

Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine

FDA approved

Allopurinol

FDA approved

Placebo Matching Colchicine

2008

Completed Phase 2

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