Clinical trial NCT00819585: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Keywords: Gout
Chronic gout
Gouty arthritis
Gout flares
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Core Study: Mean Number of Gout Flares Per Participant
timeFrame: Baseline of the core study to Week 16
Secondary outcomes:
measure: Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
timeFrame: up to 16 weeks after randomization
measure: Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
timeFrame: Baseline of the core study to Week 16
measure: Core Study: Percentage of Participants With Gout Flare at Different Time Points
timeFrame: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
measure: Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
timeFrame: Baseline of the core study to Week 16
measure: Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
timeFrame: Baseline of the core study to Week 16
measure: Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
timeFrame: Days 15, 29, 57, 85, 113, and 141 of the core study
measure: Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
timeFrame: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
measure: Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
timeFrame: Baseline of the extension study until the end of the study (up to 24 weeks)
measure: Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
timeFrame: Baseline of the extension study until the end of the study (up to 24 weeks)
measure: Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
timeFrame: Baseline of the extension study until the end of the study (up to 24 weeks)
measure: Extension Study: Amount of Rescue Medication Taken
timeFrame: Baseline of the extension study until the end of the study (up to 24 weeks)
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Arthritis & Osteoporosis Medical clinic
state: California
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research institute
state: Hawaii
city: Overland Park
country: United States
facility: Pinnacle Medical Research
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Institute
state: Kansas
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: The Family Doctors
state: Louisiana
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Albuquerque
country: United States
facility: NM Clinical Research & Osteoporosis Ct.
state: New Mexico
city: Rochester
country: United States
facility: Rochester clinical Research
state: New York
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma, PLLC
state: Oklahoma
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants, LLC
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research
state: Tennessee
city: San Antonio
country: United States
facility: iMED Internal medicine, PA
state: Texas
city: Buenos Aires
country: Argentina
facility: Novartis Investigative site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Rosario
country: Argentina
facility: Novartis Investigative site
city: Gozée
country: Belgium
facility: Novartis Investigative Site
city: Oostham
country: Belgium
facility: Novartis Investigative site
city: Bacaramanga
country: Colombia
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Florida Blanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
city: Havirov
country: Czechia
facility: Novartis Investigative site
city: Ostrava
country: Czechia
facility: Novartis Investigative site
city: Pardubice
country: Czechia
facility: Novartis Investigative site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative site
city: Zlin
country: Czechia
facility: Novartis Investigative site
city: Bautzen
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Georgensgmuend
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Messkirch
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Riedlhuette
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Zalaegerszeg
country: Hungary
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative site
city: Lisboa
country: Portugal
facility: Novartis Investigative site
city: Ponte de Lima
country: Portugal
facility: Novartis Investigative site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Piestany
country: Slovakia
facility: Novartis Investigative Site
city: Povazska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Trebisova
country: Slovakia
facility: Novartis Investigative site
city: Cape Town
country: South Africa
facility: Novartis Investigative site
city: Panorama
country: South Africa
facility: Novartis Investigative site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigative site
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Merida
country: Spain
facility: Novartis Investigative site
city: Valencia
country: Spain
facility: Novartis Investigative site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative site
city: Taichung
country: Taiwan
facility: Novartis Investigative site
city: Taipei
country: Taiwan
facility: Novartis Investigative site
city: Adana
country: Turkey
facility: Baskent University Medical Faculty
city: Ankara
country: Turkey
facility: Baskent University Medical Faculty
city: Aydin
country: Turkey
facility: Adnan Menderes University Medical Faculty
city: Balcali Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Denizli Kampus
country: Turkey
facility: Pamukkale University medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Manisa
country: Turkey
facility: Celal Bayar University Medical Faculty
city: Coventry
country: United Kingdom
facility: Gables Medicentre
city: Lancashire
country: United Kingdom
facility: Flyde Coast Clinical Research Ltd
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: