Clinical trial NCT01431638: Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Official title: A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gouty Arthritis
Keywords: Gout
arthritis
gout flare
acute gout
gouty
rheumatic disease
uric acid
podagra
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-09-09
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled
Primary purpose: TREATMENT

Brief summary: This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.


Eligibility criteria: Inclusion criteria:

* Compliance and completion of the canakinumab PFS core study
* Unchanged significant clinical medical history from entry into core study

Exclusion criteria:

* Physician judgment of unsuitability for the study
* Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants Who Reported Adverse Events
timeFrame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Secondary outcomes:
measure: Probability of New Gout Flares at End of Study
timeFrame: Up to Day 337
measure: Number of Participant With New Flares
timeFrame: up to 36 weeks
measure: Change From Baseline in Pain Intensity on a 5-point Likert Scale
timeFrame: Baseline, upto 14 days post-dose
measure: Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
timeFrame: Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose
measure: Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
timeFrame: 48 weeks post-dose
measure: Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
timeFrame: Baseline, 7 days post-dose
measure: Number of Participants Responded for Physician's Global Assessment of Response to Treatment
timeFrame: 7 days post-dose
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Gulf Shores
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Buena Park
country: United States
facility: Novartis Investigative Site
state: California
city: Norwalk
country: United States
facility: Novartis Investigative Site
state: California
city: Westlake Village
country: United States
facility: Novartis Investigative Site
state: California
city: Jupiter
country: United States
facility: Novartis Investigative Site
state: Florida
city: Largo
country: United States
facility: Novartis Investigative Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Decatur
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Owensboro
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Belzoni
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Picayune
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Mineola
country: United States
facility: Novartis Investigative Site
state: New York
city: New Hyde Park
country: United States
facility: Novartis Investigative Site
state: New York
city: Roslyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cary
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Mogadore
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Fort Mill
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Varnville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Bristol
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Bedford
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: League City
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bountiful
country: United States
facility: Novartis Investigative Site
state: Utah
city: Danville
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Midlothian
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Washington
city: St-John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Weener
country: Germany
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: