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)

Conditions

• Gout

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — DRUG
  Canakinumab was supplied in glass vials as a lyophilized powder.
• Colchicine — DRUG
  0.5 mg capsule orally once daily for 16 weeks.
• Allopurinol — DRUG
  100-300 mg orally once daily for 24 weeks.
• Placebo Matching Canakinumab — DRUG
  Subcutaneous injection.
• Placebo Matching Colchicine — DRUG
  Capsule orally once daily for 16 weeks.

Study Details

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.

Key Dates

Start date

Dec 31, 2008

Status verified

Jun 2018

Primary completion

Aug 31, 2010

Completion

Aug 31, 2010

Study Design

Enrollment

432 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Core study: Canakinumab 25 mg
  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.
• Experimental: Core study: Canakinumab 50 mg
  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.
• Experimental: Core study: Canakinumab 100 mg
  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.
• Experimental: Core study: Canakinumab 200 mg
  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.
• Experimental: Core study: Canakinumab 300 mg
  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.
• Experimental: Core study: Canakinumab q4wk
  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.
• Active Comparator: Core study: Colchicine 0.5 mg
  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.
• Experimental: Extension study: Group A
  Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
• Experimental: Extension study: Group B
  Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.
• Experimental: Extension study: Group C
  Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
• Experimental: Extension study: Group D
  Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.

Primary Outcome Measure

Core Study: Mean Number of Gout Flares Per Participant [ Time Frame: Baseline of the core study to Week 16 ]

Locations (19)

Find similar trials in Huntington Beach, CA

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