Status:
COMPLETED
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gouty Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2010
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00927810
Start Date
June 5 2009
End Date
August 4 2010
Last Update
July 2 2021
Active Locations (45)
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1
Novartis Investigative site
Seattle, Washington, United States, 98101
2
Novartis Investigative site
Capital Federal Buenos Aires, Argentina, 1027
3
Novartis Investigative site
Jette, Belgium, 1090
4
Novartis Investigative site
Barranquilla, Colombia