A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

432

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Gout
Interventions
DRUG

Canakinumab

Canakinumab was supplied in glass vials as a lyophilized powder.

DRUG

Colchicine

0.5 mg capsule orally once daily for 16 weeks.

DRUG

Allopurinol

100-300 mg orally once daily for 24 weeks.

DRUG

Placebo Matching Canakinumab

Subcutaneous injection.

DRUG

Placebo Matching Colchicine

Capsule orally once daily for 16 weeks.

Trial Locations (89)

14609

Rochester clinical Research, Rochester

16635

Altoona Center for Clinical Research, Duncansville

29201

Columbia Clinical Research, Columbia

29615

Upstate Pharmaceutical Research, Greenville

33458

Health Awareness, Jupiter

48081

Shores Rheumatology, Saint Clair Shores

66215

Pinnacle Medical Research, Overland Park

70809

Dolby Research, LLC, Baton Rouge

71115

The Family Doctors, Shreveport

73103

Health Research of Oklahoma, PLLC, Oklahoma City

74136

Castlerock Clinical Research Consultants, LLC, Tulsa

78228

iMED Internal medicine, PA, San Antonio

92646

Talbert Medical Group, Huntington Beach

96814

East-West Medical Research institute, Honolulu

Unknown

San Diego Arthritis & Osteoporosis Medical clinic, San Diego

Cotton O'Neil Clinical Research Institute, Topeka

Heartland Clinical Research, Inc., Omaha

NM Clinical Research & Osteoporosis Ct., Albuquerque

MultiSpecialty Clinical Research, Johnson City

Novartis Investigative site, Buenos Aires

Novartis Investigative Site, Córdoba

Novartis Investigative site, Rosario

Novartis Investigative Site, Gozée

Novartis Investigative site, Oostham

Novartis Investigative Site, Bacaramanga

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Bogotá

Fundación Cardiovascular de Colombia, Florida Blanca

Novartis Investigative site, Havířov

Novartis Investigative site, Ostrava

Novartis Investigative site, Pardubice

Novartis Investigative site, Uherské Hradiště

Novartis Investigative site, Zlín

Novartis Investigative Site, Bautzen

Novartis Investigative Site, Chemnitz

Novartis Investigative Site, Dresden

Novartis Investigative Site, Frankfurt

Novartis Investigative Site, Georgensgmünd

Novartis Investigative Site, Göttingen

Novartis Investigative Site, Hamburg

Novartis Investigative Site, Magdeburg

Novartis Investigative Site, Messkirch

Novartis Investigative Site, München

Novartis Investigative Site, Riedlhuette

Novartis Investigative Site, Schwabach

Novartis Investigative site, Guatemala City

Novartis Investigative Site, Debrecen

Novartis Investigative Site, Eger

Novartis Investigative Site, Kistarcsa

Novartis Investigative Site, Zalaegerszeg

Novartis Investigative Site, Poznan

Novartis Investigative Site, Wroclaw

Novartis Investigative site, Coimbra

Novartis Investigative site, Lisbon

Novartis Investigative site, Ponte de Lima

Novartis Investigative Site, Chelyabinsk

Novartis Investigative site, Moscow

Novartis Investigative Site, Petrozavodsk

Novartis Investigative Site, Saint Petersburg

Novartis Investigative Site, Yaroslavl

Novartis Investigative Site, Yekaterinburg

Novartis Investigative site, Singapore

Novartis Investigative Site, Banská Bystrica

Novartis Investigative Site, Bratislava

Novartis Investigative Site, Košice

Novartis Investigative Site, Nové Zámky

Novartis Investigative Site, Piešťany

Novartis Investigative Site, Považská Bystrica

Novartis Investigative site, Trebišov

Novartis Investigative site, Cape Town

Novartis Investigative site, Panorama

Novartis Investigative site, Port Elizabeth

Novartis Investigative Site, Barakaldo

Novartis Investigative site, Madrid

Novartis Investigative site, Mérida

Novartis Investigative site, Valencia

Novartis Investigative site, Kaohsiung City

Novartis Investigative site, Taichung

Novartis Investigative site, Taipei

Baskent University Medical Faculty, Adana

Baskent University Medical Faculty, Ankara

Adnan Menderes University Medical Faculty, Aydin

Cukurova University Medical Faculty, Balcali Adana

Pamukkale University medical Faculty, Denizli Kampus

Gaziantep University Medical Faculty, Gaziantep

Dokuz Eylul University Medical Faculty, Izmir

Celal Bayar University Medical Faculty, Manisa

Gables Medicentre, Coventry

Flyde Coast Clinical Research Ltd, Lancashire

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY