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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Gouty Arthritis
• Intervention / Treatment: Drug: Canakinumab 150mg in prefilled syringe

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St-John's, Newfoundland and Labrador, Canada, A1E 2C2
      • Novartis Investigative Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1v 3M7
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Loehne, Germany, 32584
    • Novartis Investigative Site
  • Magdeburg, Germany, 39110
    • Novartis Investigative Site
  • Weener, Germany, 26826
    • Novartis Investigative Site
  • Bavaria
    • Regensburg, Bavaria, Germany, 93053
      • Novartis Investigative Site
• Lithuania
  • Klaipeda, Lithuania, LT-92288
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-08661
    • Novartis Investigative Site
  • Vilnius, Lithuania, 09310
    • Novartis Investigative Site
  • LT
    • Kaunas, LT, Lithuania, LT-50128
      • Novartis Investigative Site
    • Kaunas, LT, Lithuania, 51349
      • Novartis Investigative Site
    • Vilnius, LT, Lithuania, 01117
      • Novartis Investigative Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207-5710
      • Novartis Investigative Site
    • Gulf Shores, Alabama, United States, 36547
      • Novartis Investigative Site
    • Mobile, Alabama, United States, 36608
      • Novartis Investigative Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Novartis Investigative Site
    • Scottsdale, Arizona, United States, 85251
      • Novartis Investigative Site
  • California
    • Buena Park, California, United States, 90620
      • Novartis Investigative Site
    • Norwalk, California, United States, 90650
      • Novartis Investigative Site
    • Westlake Village, California, United States, 91361
      • Novartis Investigative Site
  • Florida
    • Jupiter, Florida, United States, 33458
      • Novartis Investigative Site
    • Largo, Florida, United States, 33773
      • Novartis Investigative Site
    • South Miami, Florida, United States, 33143
      • Novartis Investigative Site
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Novartis Investigative Site
    • Decatur, Georgia, United States, 30035
      • Novartis Investigative Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Novartis Investigative Site
    • Owensboro, Kentucky, United States, 42303
      • Novartis Investigative Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Novartis Investigative Site
  • Michigan
    • Troy, Michigan, United States, 48085
      • Novartis Investigative Site
  • Mississippi
    • Belzoni, Mississippi, United States, 39038
      • Novartis Investigative Site
    • Jackson, Mississippi, United States, 39209
      • Novartis Investigative Site
    • Picayune, Mississippi, United States, 39466
      • Novartis Investigative Site
  • Montana
    • Missoula, Montana, United States, 59804
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68114
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68134
      • Novartis Investigative Site
  • New York
    • Mineola, New York, United States, 11501
      • Novartis Investigative Site
    • New Hyde Park, New York, United States, 11042
      • Novartis Investigative Site
    • Roslyn, New York, United States, 11576
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Novartis Investigative Site
    • Cary, North Carolina, United States, 27518
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28209
      • Novartis Investigative Site
    • Greensboro, North Carolina, United States, 27401
      • Novartis Investigative Site
    • Salisbury, North Carolina, United States, 28144
      • Novartis Investigative Site
    • Shelby, North Carolina, United States, 28152
      • Novartis Investigative Site
    • Wilmington, North Carolina, United States, 28401
      • Novartis Investigative Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Novartis Investigative Site
  • Ohio
    • Mogadore, Ohio, United States, 44260
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Novartis Investigative Site
    • Columbia, South Carolina, United States, 29204
      • Novartis Investigative Site
    • Fort Mill, South Carolina, United States, 29707
      • Novartis Investigative Site
    • Greer, South Carolina, United States, 29651
      • Novartis Investigative Site
    • Varnville, South Carolina, United States, 29944
      • Novartis Investigative Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Novartis Investigative Site
    • Johnson City, Tennessee, United States, 37601
      • Novartis Investigative Site
    • Memphis, Tennessee, United States, 38125
      • Novartis Investigative Site
  • Texas
    • Bedford, Texas, United States, 76021
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigative Site
    • League City, Texas, United States, 77573
      • Novartis Investigative Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • Novartis Investigative Site
  • Virginia
    • Danville, Virginia, United States, 24541
      • Novartis Investigative Site
    • Midlothian, Virginia, United States, 23114
      • Novartis Investigative Site
    • Newport News, Virginia, United States, 23606
      • Novartis Investigative Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Canakinumab 150mg; Canakinumab 150mg in prefilled syringe subcutaneously	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Reported Adverse Events	From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2011
• Primary Completion (ACTUAL): May 9, 2013
• Study Completion (ACTUAL): May 9, 2013

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (ESTIMATE): September 9, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Gout; uric acid; arthritis; acute gout; rheumatic disease; gout flare; gouty; podagra
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty
• Other Study ID Numbers: CACZ885H2361E1; 2011-001342-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com