Long Term Study of Canakinumab (ACZ885) in Patients With Gout - Full Text View

Purpose

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	Intervention	Phase
Gout	Drug: Canakinumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Canakinumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate, in the extension study, the safety and tolerability in gout patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	July 2009
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: canakinumab	Drug: Canakinumab

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927810

Show 22 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00927810 History of Changes
Other Study ID Numbers:	CACZ885H2251E1
Study First Received:	June 23, 2009
Last Updated:	May 31, 2012
Health Authority:	Argentina: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products Colombia: National Institutes of Health Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Guatemala: Ministry of Health Hungary: National Institute of Pharmacy Portugal: National Pharmacy and Medicines Institute Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Pharmacological Committee, Ministry of Health Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Taiwan: Department of Health Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Venezuela: Nacional de Higiene Rafael Rangel

Keywords provided by Novartis:

Gout
Gouty arthritis
Gout flares
Anti-interleukin-1β monoclonal antibody

Additional relevant MeSH terms:

Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors

Genetic Diseases, Inborn
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013