Long Term Study of Canakinumab (ACZ885) in Patients With Gout

A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Study Overview

• Status: Completed
• Conditions: Gouty Arthritis
• Intervention / Treatment: Drug: Canakinumab

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal Buenos Aires, Argentina, 1027
    • Novartis Investigative Site
• Belgium
  • Jette, Belgium, 1090
    • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia
    • Novartis Investigative Site
  • Bogotá, Colombia
    • Novartis Investigative Site
  • Bucaramanga, Colombia
    • Novartis Investigative Site
  • Floridablanca, Colombia
    • Novartis Investigative Site
• Czechia
  • Czech Republic
    • Praha 5, Czech Republic, Czechia, 15006
      • Novartis Investigative Site
• Germany
  • Dresden / Schützenhöhe 16
    • Sachsen, Dresden / Schützenhöhe 16, Germany, D-01099
      • Novartis Investigative Site
  • München / Mühlbaurstraße 16
    • Bayern, München / Mühlbaurstraße 16, Germany, D-81677
      • Novartis Investigative Site
  • Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
    • Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, Germany, D-06846
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01015
    • Novartis Investigative Site
• Hungary
  • Bartók B U 2-26
    • Debrecen, Bartók B U 2-26, Hungary, 4043
      • Novartis Investigative Site
  • Semmelweis Tér 1.
    • Kistarcsa, Semmelweis Tér 1., Hungary, 2143
      • Novartis Investigative Site
  • Széchenyi U 27-29
    • Eger, Széchenyi U 27-29, Hungary, 3301
      • Novartis Investigative Site
  • Zrínyi U 1
    • Zalaegerszeg, Zrínyi U 1, Hungary, 8900
      • Novartis Investigative Site
• Poland
  • Poznań, Poland, NA 61- 734
    • Novartis Investigative Site
  • Wrocław, Poland, NA 50-333
    • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1749-004
    • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454047
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115522
    • Novartis Investigative Site
  • Moscow, Russian Federation, 127473
    • Novartis Investigative Site
  • Petrozavodsk, Russian Federation
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 190068
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 193015
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 169611
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, N/A 813 69
    • Novartis Investigative Site
  • Košice, Slovakia, N/A 042 66
    • Novartis Investigative Site
  • Nitra, Slovakia, N/A 949 01
    • Novartis Investigative Site
  • Piešťany, Slovakia, N/A 921 12
    • Novartis Investigative Site
  • Trenčín, Slovakia, N/A 911 50
    • Novartis Investigative Site
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0153
      • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28046
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 81346
    • Novartis Investigative Site
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Taipei, Taiwan, 11217
    • Novartis Investigative Site
• Turkey
  • Bahcellievler
    • Ankara, Bahcellievler, Turkey, 06490
      • Novartis Investigative Site
  • Balcali
    • Adana, Balcali, Turkey, 01330
      • Novartis Investigative Site
  • Inciraltı
    • İzmir, Inciraltı, Turkey, 35340
      • Novartis Investigative Site
  • Merkez
    • Aydın, Merkez, Turkey, 09100
      • Novartis Investigative Site
    • Manisa, Merkez, Turkey, 45010
      • Novartis Investigative Site
  • Sehitkamil
    • Gaziantep, Sehitkamil, Turkey, 27310
      • Novartis Investigative Site
• United Kingdom
  • Tyne & Wear
    • Jarrow, Tyne & Wear, United Kingdom, NE32 3DT
      • Novartis Investigative Site
• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who completed the core study CACZ885H2251. 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 1 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).

• Female patients who were physiologically capable of becoming pregnant, unless they were:

  • Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
  • Female patients whose partners had been sterilized by vasectomy or other means.
  • Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
  • Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: canakinumab	Drug: Canakinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events and Serious Adverse Events	Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards	From start of study up to study completion (up to 14 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Change From Baseline in Participant's Gout Pain During First Flare	Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.	Baseline and Day 7
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category	Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.	24 weeks
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category	Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.	24 weeks
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group	Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.	24 weeks
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group	The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.	24 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2009
• Primary Completion (Actual): August 4, 2010
• Study Completion (Actual): August 4, 2010

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Gout flares; Anti-interleukin-1β monoclonal antibody; Gouty arthritis; Gouty
• 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: CACZ885H2251E1