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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Intervention: Canakinumab 25 mg (Drug); Canakinumab 50 mg (Drug); Canakinumab 100 mg (Drug); Canakinumab 200 mg (Drug); Canakinumab 300 mg (Drug); Canakinumab repeated every 4 week (q4wk) (Drug); Colchicine (Drug); Allopurinol (Drug); Placebo Matching Canakinumab (Drug); Placebo Matching Colchicine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: The Mean Number of Gout Flares for Each Treatment Arm

Secondary outcome:

The Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab

The Percentage of Participants With Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine

The Percentage of Participants With Gout Flare at Different Time Points for Each Canakinumab Treatment Arm as Compared to Colchicine

Patient's Global Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine

Patient's Global Pain Intensity on 5-point Likert Scale up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine

Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale for Each Canakinumab Treatment Arm as Compared to Colchicine

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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 American College of Rheumatology (ACR) 1977

preliminary criteria for the classification of arthritis of primary gout.

- Body Mass Index (BMI) ≤ 40 kg/m^2.

- Willingness to initiate allopurinol therapy as urate lowering agent for their gout

therapy or having initiated allopurinol therapy within ≤ 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 colchicine 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

Locations and Contacts

Novartis Investigative site, Buenos Aires, Argentina

Novartis Investigative Site, Cordoba, Argentina

Novartis Investigative site, Rosario, Argentina

Novartis Investigative Site, Gozée, Belgium

Novartis Investigative site, Oostham, Belgium

Novartis Investigative Site, Bacaramanga, Colombia

Novartis Investigative Site, Barranquilla, Colombia

Novartis Investigative Site, Bogota, Colombia

Fundación Cardiovascular de Colombia, Florida Blanca, Colombia

Novartis Investigative site, Havirov, Czech Republic

Novartis Investigative site, Ostrava, Czech Republic

Novartis Investigative site, Pardubice, Czech Republic

Novartis Investigative site, Uherske Hradiste, Czech Republic

Novartis Investigative site, Zlin, Czech Republic

Novartis Investigative Site, Bautzen, Germany

Novartis Investigative Site, Chemnitz, Germany

Novartis Investigative Site, Dresden, Germany

Novartis Investigative Site, Frankfurt, Germany

Novartis Investigative Site, Georgensgmuend, Germany

Novartis Investigative Site, Goettingen, Germany

Novartis Investigative Site, Hamburg, Germany

Novartis Investigative Site, Magdeburg, Germany

Novartis Investigative Site, Messkirch, Germany

Novartis Investigative Site, Muenchen, Germany

Novartis Investigative Site, Riedlhuette, Germany

Novartis Investigative Site, Schwabach, Germany

Novartis Investigative site, Guatemala City, Guatemala

Novartis Investigative Site, Debrecen, Hungary

Novartis Investigative Site, Eger, Hungary

Novartis Investigative Site, Kistarcsa, Hungary

Novartis Investigative Site, Zalaegerszeg, Hungary

Novartis Investigative Site, Poznan, Poland

Novartis Investigative Site, Wroclaw, Poland

Novartis Investigative site, Coimbra, Portugal

Novartis Investigative site, Lisboa, Portugal

Novartis Investigative site, Ponte de Lima, Portugal

Novartis Investigative Site, Chelyabinsk, Russian Federation

Novartis Investigative Site, Ekaterinburg, Russian Federation

Novartis Investigative site, Moscow, Russian Federation

Novartis Investigative Site, Petrozavodsk, Russian Federation

Novartis Investigative Site, St. Petersburg, Russian Federation

Novartis Investigative Site, Yaroslavl, Russian Federation

Novartis Investigative site, Singapore, Singapore

Novartis Investigative Site, Banska Bystrica, Slovakia

Novartis Investigative Site, Bratislava, Slovakia

Novartis Investigative Site, Kosice, Slovakia

Novartis Investigative Site, Nove Zamky, Slovakia

Novartis Investigative Site, Piestany, Slovakia

Novartis Investigative Site, Povazska Bystrica, Slovakia

Novartis Investigative site, Trebisova, Slovakia

Novartis Investigative site, Cape Town, South Africa

Novartis Investigative site, Panorama, South Africa

Novartis Investigative site, Port Elizabeth, South Africa

Novartis Investigative Site, Barakaldo, Spain

Novartis Investigative site, Madrid, Spain

Novartis Investigative site, Merida, Spain

Novartis Investigative site, Valencia, Spain

Novartis Investigative site, Kaohsiung, Taiwan

Novartis Investigative site, Taichung, Taiwan

Novartis Investigative site, Taipei, Taiwan

Baskent University Medical Faculty, Adana, Turkey

Baskent University Medical Faculty, Ankara, Turkey

Adnan Menderes University Medical Faculty, Aydin, Turkey

Cukurova University Medical Faculty, Balcali Adana, Turkey

Pamukkale University medical Faculty, Denizli Kampus, Turkey

Gaziantep University Medical Faculty, Gaziantep, Turkey

Dokuz Eylul University Medical Faculty, Izmir, Turkey

Celal Bayar University Medical Faculty, Manisa, Turkey

Gables Medicentre, Coventry, United Kingdom

Flyde Coast Clinical Research Ltd, Lancashire, United Kingdom

Talbert Medical Group, Huntington Beach, California 92646, United States

San Diego Arthritis & Osteoporosis Medical clinic, San Diego, California, United States

Health Awareness, Jupiter, Florida 33458, United States

East-West Medical Research institute, Honolulu, Hawaii 96814, United States

Pinnacle Medical Research, Overland Park, Kansas 66215, United States

Cotton O'Neil Clinical Research Institute, Topeka, Kansas, United States

Dolby Research, LLC, Baton Rouge, Louisiana 70809, United States

The Family Doctors, Shreveport, Louisiana 71115, United States

Shores Rheumatology, St. Clair Shores, Michigan 48081, United States

Heartland Clinical Research, Inc., Omaha, Nebraska, United States

NM Clinical Research & Osteoporosis Ct., Albuquerque, New Mexico, United States

Rochester clinical Research, Rochester, New York 14609, United States

Health Research of Oklahoma, PLLC, Oklahoma City, Oklahoma 73103, United States

Castlerock Clinical Research Consultants, LLC, Tulsa, Oklahoma 74136, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Columbia Clinical Research, Columbia, South Carolina 29201, United States

Upstate Pharmaceutical Research, Greenville, South Carolina 29615, United States

MultiSpecialty Clinical Research, Johnson City, Tennessee, United States

iMED Internal medicine, PA, San Antonio, Texas 78228, United States

Additional Information

Starting date: December 2008
Last updated: April 12, 2011

Page last updated: August 23, 2015

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