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Long Term Study of Canakinuma...

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

Last Updated: 2021-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-05

Study Completion Date

2010-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Gouty Arthritis

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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canakinumab

Group Type EXPERIMENTAL

Canakinumab

Intervention Type DRUG

Interventions

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Canakinumab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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United States Argentina Belgium Colombia Czechia Germany Guatemala Hungary Poland Portugal Russia Singapore Slovakia South Africa Spain Taiwan Turkey (Türkiye) United Kingdom