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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00819585
• Date of registration: 08/01/2009
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: December 2008
• Target sample size: 432
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00819585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Belgium, Colombia, Czech Republic, Czechia, Germany, Guatemala, Hungary, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gout

Intervention(s)

Drug: Placebo Matching Colchicine

Drug: Placebo Matching Canakinumab

Drug: Canakinumab

Drug: Colchicine

Drug: Allopurinol

Primary Outcome(s)

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

Secondary Outcome(s)

Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization [Time Frame: Baseline of the core study to Week 16]

Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare [Time Frame: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)]

Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale [Time Frame: Baseline of the extension study until the end of the study (up to 24 weeks)]

Extension Study: Amount of Rescue Medication Taken [Time Frame: Baseline of the extension study until the end of the study (up to 24 weeks)]

Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab [Time Frame: up to 16 weeks after randomization]

Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale [Time Frame: Baseline of the extension study until the end of the study (up to 24 weeks)]

Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares [Time Frame: Baseline of the core study to Week 16]

Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare [Time Frame: Baseline of the extension study until the end of the study (up to 24 weeks)]

Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares [Time Frame: Baseline of the core study to Week 16]

Core Study: Percentage of Participants With Gout Flare at Different Time Points [Time Frame: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study]

Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale [Time Frame: Days 15, 29, 57, 85, 113, and 141 of the core study]

Secondary ID(s)

CACZ885H2251

EudraCT : 2008-005876-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00819585