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

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ClinicalTrials.gov Identifier: NCT00927810
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gout Drug: Canakinumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Are Given Canakinumab at the Time of Gout Flare
Study Start Date : July 2009
Actual Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: canakinumab Drug: Canakinumab



Primary Outcome Measures :
  1. To evaluate, in the extension study, the safety and tolerability in gout patients. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To evaluate the long term follow-up safety and tolerability of prophylactic treatment of canakinumab (received in the core study), observed in the core + extension study (combined) [ Time Frame: 24 weeks ]
  2. To assess, the efficacy of canakinumab in the treatment of recurrent acute flares of gout in the extension study in patients who were treated with canakinumab (for at least one flare) in the extension study. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Other protocol defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927810


  Hide Study Locations
Locations
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United States, California
Talbert Medical Group
Huntington Beach, California, United States, 92646
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States, 92108
United States, Florida
Health Awareness
Jupiter, Florida, United States, 33458
United States, Hawaii
East-West Medical Research institute
Honolulu, Hawaii, United States, 96814
United States, Kansas
Pinnacle Medical Research
Overland Park, Kansas, United States, 66215
Cotton O'Neil Clinic
Topeka, Kansas, United States, 66606
United States, Louisiana
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
The Family Doctors
Shreveport, Louisiana, United States, 71115
United States, Michigan
Shores Rheumatology
St. Clair Shores, Michigan, United States, 48081
United States, Nebraska
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
United States, New Mexico
NM Clinical Research & Osteoporosis Ct.
Albuquerque, New Mexico, United States, 87102
United States, New York
Rochester clinical Research
Rochester, New York, United States, 14609
United States, Oklahoma
Health Research of Oklahoma, PLLC
Oklahoma City, Oklahoma, United States, 73103
Castlerock Clinical Research Consultants, LLC
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Columbia Clinical Research
Columbia, South Carolina, United States, 29201
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
United States, Tennessee
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States, 37601
Belgium
Novartis Investigative Site
Gozée, Belgium
Novartis Investigative site
Oostham, Belgium
Guatemala
Novartis Investigative site
Guatemala City, Guatemala
Singapore
Novartis Investigative site
Singapore, Singapore
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00927810     History of Changes
Other Study ID Numbers: CACZ885H2251E1
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: May 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gout
Gouty arthritis
Gout flares
Anti-interleukin-1β monoclonal antibody
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs