Clinical trial NCT01356602: Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Official title: A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.


Eligibility criteria: Inclusion criteria:

* 3 or more gout flares within last year
* Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
* Body mass index of less than or equal to 45 kg/m2

Exclusion criteria:

* Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
* Hemodialysis
* Live vaccine within 3 months before first dose
* Donation or loss of 400 mL or more within 3 months before first dose
* Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
* Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
* Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
* Significant cardiovascular conditions such as uncontrolled hypertension
* Significant medical diseases such as uncontrolled diabetes, thyroid disease
* History of malignancy of any organ system within the past 5 years
* Women who are pregnant or nursing
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
timeFrame: 72 hours post dose
Secondary outcomes:
measure: Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
timeFrame: 72 hours post dose
measure: Patient's Assessment of Pain Intensity on a 0-100mm VAS
timeFrame: 14 days
measure: Patient's Assessment of Pain Intensity on a 5-point Likert Scale
timeFrame: 72 hours
measure: Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
timeFrame: 12 weeks
measure: Time to the First New Gouty Arthritis Flare
timeFrame: 12 weeks
measure: Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
timeFrame: 14 days
measure: Time to Resolution of Gouty Arthritis Flare as Reported by Patient
timeFrame: 14 days
measure: Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
timeFrame: 72 hours
measure: Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
timeFrame: 72 hours
measure: Physician's Assessment of Tenderness
timeFrame: 72 hours
measure: Physician's Assessment of Swelling
timeFrame: 72 hours
measure: Physician's Assessment of Erythema
timeFrame: 72 hours
measure: Physician's Assessment of Range of Motion of the Most Affected Joint
timeFrame: 72 hours
measure: Proportion of Patients With Rescue Medication Intake
timeFrame: 12 weeks
measure: Time to First Rescue Medication Intake
timeFrame: 14 days
measure: Amount of Rescue Medication Taken (mg)
timeFrame: 14 days
measure: C-reactive Protein Level
timeFrame: 72 hours
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: Phoenix
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: Fair Oaks
country: United States
facility: Novartis Investigative Site
state: California
city: Norwalk
country: United States
facility: Novartis Investigative Site
state: California
city: Orangevale
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Westlake Village
country: United States
facility: Novartis Investigative Site
state: California
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
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: Meridian
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
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: 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: Freehold
country: United States
facility: Novartis Investigative Site
state: New Jersey
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: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
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: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
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: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Murrells Inlet
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Ninety Six
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: Fayetteville
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: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bountiful
country: United States
facility: Novartis Investigative Site
state: Utah
city: Charlottesville
country: United States
facility: Novartis Investigative Site
state: Virginia
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
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Bad Doberan
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
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: Messkirch
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Weener
country: Germany
facility: Novartis Investigative Site
city: Zwiesel
country: Germany
facility: Novartis Investigative Site
city: Bekescsaba
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Gyula
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Szikszo
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
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: