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)
Status and phase
Completed
Phase 2
Conditions
Gout
Treatments
Drug: Canakinumab
Drug: Placebo Matching Colchicine
Drug: Colchicine
Drug: Placebo Matching Canakinumab
Drug: Allopurinol
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
432 patients
Sex
All
Ages
18 to 80 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Core study
Inclusion Criteria:
- Signed written informed consent before any study procedure is performed.
- History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
- Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
- Body Mass Index (BMI) ≤ 40 kg/m^2.
- Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Exclusion Criteria:
- Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
- History of allergy or contraindication to colchicine or allopurinol.
- History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
- History of bone marrow suppression.
- Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
Extension study
Inclusion criteria:
- Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
- Patients who have signed a written informed consent before any trial procedure is performed.
Exclusion Criteria:
- Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
432 participants in 11 patient groups
Core study: Canakinumab 25 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Placebo Matching Canakinumab
Drug: Canakinumab
Drug: Allopurinol
Core study: Canakinumab 50 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Placebo Matching Canakinumab
Drug: Canakinumab
Drug: Allopurinol
Core study: Canakinumab 100 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Placebo Matching Canakinumab
Drug: Canakinumab
Drug: Allopurinol
Core study: Canakinumab 200 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Placebo Matching Canakinumab
Drug: Canakinumab
Drug: Allopurinol
Core study: Canakinumab 300 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Placebo Matching Canakinumab
Drug: Canakinumab
Drug: Allopurinol
Core study: Canakinumab q4wk
Experimental group
Description:
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.
Treatment:
Drug: Placebo Matching Colchicine
Drug: Canakinumab
Drug: Allopurinol
Core study: Colchicine 0.5 mg
Active Comparator group
Description:
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:
Drug: Colchicine
Drug: Placebo Matching Canakinumab
Drug: Allopurinol
Extension study: Group A
Experimental group
Description:
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Treatment:
Drug: Canakinumab
Extension study: Group B
Experimental group
Description:
Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.
Treatment:
Drug: Canakinumab
Extension study: Group C
Experimental group
Description:
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Treatment:
Drug: Colchicine
Drug: Canakinumab
Extension study: Group D
Experimental group
Description:
Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.
Treatment:
Drug: Colchicine
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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