An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years (B-Relieved)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01470989
First received: August 16, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 and CACZ885H2357E2. Overall, the treatment and follow-up period from the initial baseline visit in the core studies, and all subsequent extensions will amount to a total of up to 3 years.The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients' Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.


Condition Intervention Phase
Chronic Gouty Arthritis
Biological: canakinumab
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Safety and tolerability will be evaluated by summarizing adverse events (including infections and malignancies), vital signs and laboratory data in patients exposed to canakinumab


Secondary Outcome Measures:
  • Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Flare rate will be calculated as the number of new gout flares over the period of observations in years

  • Long-term efficacy of canakinumab defined as Patient's assessment of gout pain intensity (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Patient's assessment of gout pain intensity (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit

  • Long-term efficacy of canakinumab defined as global assessment of response to treatment (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Global assessment of response to treatment (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit

  • Long-term efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)

  • Immunogenicity of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Immunogenicity will be assessed at scheduled (every 6 months) and unscheduled visits (flare visits)

  • Safety in the concomitant use of canakinumab with different urate lowering therapy regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Safety in the concomitant use with different ULT regimens will be evaluated by summarizing adverse events (including infections and malignancies), urate lowering concomitant medications, vital signs and laboratory data in patients initiating or modifying their urate lowering therapy while exposed canakinumab


Enrollment: 229
Study Start Date: November 2011
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab Biological: canakinumab
Canakinumab 150 mg

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients who have completed the second extension studies
  • Patients who have already been treated with canakinumab in the core studies or subsequent extensions

Exclusion criteria:

  • Continuation in this extension study is considered inappropriate by the treating physician
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470989

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative site
Mobile, Alabama, United States, 36608
United States, California
Novartis Investigative site
Burbank, California, United States, 91505
United States, Florida
Novartis Investigative site
Clearwater, Florida, United States, 33756
United States, Georgia
Novartis Investigative site
Decatur, Georgia, United States, 30035
United States, Idaho
Novartis Investigative site
Boise, Idaho, United States, 83702
United States, Kansas
Novartis Investigative site
Overland Park, Kansas, United States, 66215
United States, Louisiana
Novartis Investigative site
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
Novartis Investigative site
Clarkston, Michigan, United States, 48346
United States, Mississippi
Novartis Investigative site
Jackson, Mississippi, United States, 39209
United States, Nebraska
Novartis Investigative site
Omaha, Nebraska, United States, 68114
United States, North Carolina
Novartis Investigative site
Charlotte, North Carolina, United States, 28209
United States, Ohio
Novartis Investigative site
Dayton, Ohio, United States, 45417
United States, Oklahoma
Novartis Investigative site
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Novartis Investigative site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Novartis Investigative site
Charleston, South Carolina, United States, 29407
United States, Tennessee
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Bristol, Tennessee, United States, 37620
United States, Texas
Novartis Investigative site
Lake Jackson, Texas, United States, 77566
United States, Virginia
Novartis Investigative site
Danville, Virginia, United States, 24541
Australia
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Darlinghurst, Australia
Canada
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Quebec, Canada
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St Johns, Canada
Estonia
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Parnu, Estonia
Novartis Investigative site
Tallinn, Estonia
Germany
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Augsburg, Germany
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Loehne, Germany
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Magdeburg, Germany
Latvia
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Riga, Latvia
Novartis Investigative site
Valmiera, Latvia
Lithuania
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Kaunas, Lithuania
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Kedainiai, Lithuania
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Klaipeda, Lithuania
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Siauliai, Lithuania
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Vilnius, Lithuania
Russian Federation
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Ekaterinburg, Russian Federation
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Moscow, Russian Federation
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Petrozavodsk, Russian Federation
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St Petersburg, Russian Federation
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Tver, Russian Federation
Novartis Investigative site
Yaroslavi, Russian Federation
Ukraine
Novartis Investigative site
Lviv, Ukraine
Novartis Investigative site
Uzhgorod, Ukraine
Novartis Investigative site
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01470989     History of Changes
Other Study ID Numbers: CACZ885H2357E3, 2011-003414-17
Study First Received: August 16, 2011
Last Updated: May 15, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Estonia: The State Agency of Medicine
Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration
Ukraine: Ministry of Health

Keywords provided by Novartis:
Gout
inflammatory gout
acute gout flares

Additional relevant MeSH terms:
Arthritis, Gouty
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014