Evaluating Efficacy of Canakinumab (ACZ885) in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00819585

Purpose

A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy

Condition	Intervention	Phase
Gout	Drug: ACZ885 Drug: Colchicine	Phase II

MedlinePlus related topics: Gout

Drug Information available for: Colchicine Allopurinol Allopurinol sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A 24-Week, Dose-Ranging, Multi-Center, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate Canakinumab (ACZ885) for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy

Further study details as provided by Novartis:

Primary Outcome Measures:

To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of a repeat dose regimen of canakinumab as compared to the single doses of canakinumab with regards to the mean number of gout flares up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the number of patients with gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the time to first gout flare with canakimunab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate Patient's global pain intensity on a 0-100 mm VAS and 5-point Likert scale during gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician's global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	December 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Canakinumab 25 mg s.c. once on Day 1: Experimental	Drug: ACZ885
Canakinumab 50 mg s.c. once on Day 1: Experimental	Drug: ACZ885
Canakinumab 50 mg s.c. followed by canakinumab 25 mg s.c.: Experimental	Drug: ACZ885
Canakinumab 300 mg s.c. once on Day 1: Experimental	Drug: ACZ885
Colchicine 0.5 mg capsule orally once daily for 16 weeks: Active Comparator	Drug: Colchicine
Canakinumab 100 mg s.c. once on Day 1: Experimental	Drug: ACZ885
Canakinumab 200 mg s.c. once on Day 1: Experimental	Drug: ACZ885

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to the Screening Visit (based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the ACR 1977 preliminary criteria for the classification of arthritis of primary gout.
BMI < or = to 40 kg/m2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within < or = to 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion Criteria:

Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period
History of allergy or contraindication to colchicine or allopurinol
History of intolerance to allopurinol or to oral colchine in appropriate dose for prophylactic use
History of bone marrow suppression
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819585

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, California
Talbert Medical Group	Not yet recruiting
Huntington Beach, California, United States, 92646
United States, Florida
Health Awareness	Not yet recruiting
Jupiter, Florida, United States, 33458
United States, Hawaii
East-West Medical Research institute	Recruiting
Honolulu, Hawaii, United States, 96814
United States, Kansas
Pinnacle Medical Research	Not yet recruiting
Overland Park, Kansas, United States, 66215
United States, Louisiana
The Family Doctors	Not yet recruiting
Shreveport, Louisiana, United States, 71115
Dolby Research, LLC	Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Good Samaritan Hospital of Maryland	Not yet recruiting
Baltimore, Maryland, United States, 21239
United States, Michigan
Shores Rheumatology	Not yet recruiting
St. Clair Shores, Michigan, United States, 48081
United States, New York
Rochester clinical Research	Not yet recruiting
Rochester, New York, United States, 14609
United States, Oklahoma
Health Research of Oklahoma, PLLC	Not yet recruiting
Oklahoma City, Oklahoma, United States, 73103
Castlerock Clinical Research Consultants, LLC	Not yet recruiting
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Altoona Center for Clinical Research	Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Columbia Clinical Research	Not yet recruiting
Columbia, South Carolina, United States, 29201
Upstate Pharmaceutical Research	Not yet recruiting
Greenville, South Carolina, United States, 29615
United States, Texas
iMED Internal medicine, PA	Not yet recruiting
San Antonio, Texas, United States, 78228
Belgium
Novartis Investigative Site	Not yet recruiting
Gozée, Belgium
Novartis Investigative site	Not yet recruiting
Oostham, Belgium
Novartis Investigative Site	Recruiting
Brussels, Belgium
Guatemala
Novartis Investigative site	Not yet recruiting
Guatemala City, Guatemala
Singapore
Novartis Investigative site	Not yet recruiting
Singapore, Singapore

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CACZ885H2251, EudraCT : 2008-005876-28
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819585
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; Finland: National Agency for Medicines; 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; Switzerland: Federal Office of Public Health; 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
Chronic Gout
Gouty arthritis
Gout flares

Study placed in the following topic categories:

Allopurinol
Metabolic Diseases
Joint Diseases
Rheumatic Diseases
Gout
Purine-Pyrimidine Metabolism, Inborn Errors
Arthritis, Gouty

Signs and Symptoms
Metabolism, Inborn Errors
Musculoskeletal Diseases
Genetic Diseases, Inborn
Arthritis
Colchicine
Metabolic disorder

Additional relevant MeSH terms:

Antimetabolites
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents

Gout Suppressants
Protective Agents
Pharmacologic Actions
Therapeutic Uses
Free Radical Scavengers
Tubulin Modulators
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009