Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Acute Gout
Interventions
DRUG

Canakinumab 150 mg

Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).

DRUG

Triamcinolone acetonide 40 mg

Triamcinolone acetonide 40 mg was supplied as a suspension.

DRUG

Placebo to canakinumab

Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.

DRUG

Placebo to triamcinolone acetonide

Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.

Trial Locations (47)

Unknown

Novartis Investigative Site, Darlinghurst

Novartis Investigative Site, Fitzroy

Novartis Investigative Site, Heidelberg

Novartis Investigative Site, Daw Park SA

Novartis Investigative site, Gozée

Novartis Investigative Site, Mount Pearl

Novartis Investigative site, St. John's

Novartis Investigative site, Hamilton

Novartis Investigative site, Barranquilla

Novartis Investigative site, Bogotá

Novartis Investigative site, Bucaramanga

Novartis Investigative site, Pärnu

Novartis Investigative site, Tallinn

Novartis Investigative site, Tartu

Novartis Investigative Site, Bayreuth

Novartis Investigative Site, Berlin

Novartis Investigative Site, Leipzig

Novartis Investigative Site, Löhne

Novartis Investigative Site, Magdeburg

Novartis Investigative site, Munich

Novartis Investigative Site, Guatemala City

Novartis Investigative Site, Riga

Novartis Investigative Site, Valmiera

Novartis Investigative Site, Kaunas

Novartis Investigative Site, Kėdainiai

Novartis Investigative site, Klaipėda

Novartis Investigative Site, Šiauliai

Novartis Investigative Site, Vilnius

Novartis Investigative site, Culiacán

Novartis Investigative site, Guadalajara

Novartis Investigative site, Mexicali

Novartis Investigative site, Oslo

Novartis Investigative site, Katowice

Novartis Investigative site, Kutno

Novartis Investigative site, Lublin

Novartis Investigative Site, Wroclaw

Novartis Investigative site, Moscow

Novartis Investigative site, Yaroslavl

Novartis Investigative site, Yekaterinburg

Novartis Investigative site, Singapore

Novartis Investigative Site, Gothenburg

Novartis Investigative site, Stockholm

Novartis Investigative Site, Lausanne

Novartis Investigative Site, Donetsk

Novartis Investigative Site, Kyiv

Novartis Investigative Site, Lviv

Novartis Investigative Site, Zaporizhzhya

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY