Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Acute Gouty Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431638
• Other study ID #: CACZ885H2361E1
• Secondary ID: 2011-001342-15
• Status: Completed
• Phase: Phase 3
• Start date: August 25, 2011
• Est. completion date: May 9, 2013

Study information

• Verified date: June 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: May 9, 2013
• Est. primary completion date: May 9, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gouty Arthritis
• Arthritis
• Arthritis, Gouty

Intervention

Drug:
• Canakinumab 150mg in prefilled syringe
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Sainte-Foy	Quebec
Canada	Novartis Investigative Site	St-John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Regensburg	Bavaria
Germany	Novartis Investigative Site	Weener
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius	LT
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Bedford	Texas
United States	Novartis Investigative Site	Bellevue	Washington
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Novartis Investigative Site	Bountiful	Utah
United States	Novartis Investigative Site	Bristol	Tennessee
United States	Novartis Investigative Site	Buena Park	California
United States	Novartis Investigative Site	Cary	North Carolina
United States	Novartis Investigative Site	Chandler	Arizona
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Danville	Virginia
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Fort Mill	South Carolina
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	Gulf Shores	Alabama
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Jupiter	Florida
United States	Novartis Investigative Site	Largo	Florida
United States	Novartis Investigative Site	League City	Texas
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Midlothian	Virginia
United States	Novartis Investigative Site	Mineola	New York
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Mogadore	Ohio
United States	Novartis Investigative Site	New Hyde Park	New York
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Norwalk	California
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Picayune	Mississippi
United States	Novartis Investigative Site	Roslyn	New York
United States	Novartis Investigative Site	Salisbury	North Carolina
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Troy	Michigan
United States	Novartis Investigative Site	Varnville	South Carolina
United States	Novartis Investigative Site	Westlake Village	California
United States	Novartis Investigative Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Reported Adverse Events		From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Secondary	Probability of New Gout Flares at End of Study	The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.	Up to Day 337
Secondary	Number of Participant With New Flares	The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.	up to 36 weeks
Secondary	Change From Baseline in Pain Intensity on a 5-point Likert Scale	A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.	Baseline, upto 14 days post-dose
Secondary	Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time	Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.	Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose
Secondary	Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment	Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).	48 weeks post-dose
Secondary	Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint	Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.	Baseline, 7 days post-dose
Secondary	Number of Participants Responded for Physician's Global Assessment of Response to Treatment	The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.	7 days post-dose