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

Completed · Phase 2

Conditions studied: Gouty Arthritis

In brief

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.

Key facts

Study ID

NCT00927810

Run by

Novartis Pharmaceuticals

People needed

341

Starts

2009-06-05

Expected to finish

2010-08-04

Last updated by the study team

2021-07-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative site — Seattle, Washington, United States
• Novartis Investigative site — Capital Federal Buenos Aires, Argentina
• Novartis Investigative site — Jette, Belgium
• Novartis Investigative site — Barranquilla, Colombia
• Novartis Investigative site — Bogotá, Colombia
• Novartis Investigative site — Bucaramanga, Colombia
• Novartis Investigative site — Floridablanca, Colombia
• Novartis Investigative site — Prague, Czech Republic, Czechia
• Novartis Investigative site — Sachsen, Dresden / Schützenhöhe 16, Germany
• Novartis Investigative site — Bayern, München / Mühlbaurstraße 16, Germany
• Novartis Investigative site — Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, Germany
• Novartis Investigative site — Guatemala City, Guatemala
• Novartis Investigative site — Debrecen, Bartók B U 2-26, Hungary
• Novartis Investigative site — Kistarcsa, Semmelweis Tér 1., Hungary
• Novartis Investigative site — Eger, Széchenyi U 27-29, Hungary
• Novartis Investigative site — Zalaegerszeg, Zrínyi U 1, Hungary
• Novartis Investigative site — Poznan, Poland
• Novartis Investigative site — Wroclaw, Poland
• Novartis Investigative site — Lisbon, Portugal
• Novartis Investigative site — Chelyabinsk, Russia
• Novartis Investigative site — Moscow, Russia
• Novartis Investigative site — Moscow, Russia
• Novartis Investigative site — Petrozavodsk, Russia
• Novartis Investigative site — Saint Petersburg, Russia
• Novartis Investigative site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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