Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Gouty

In brief

This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Key facts

Study ID

NCT00663169

Run by

Novartis

People needed

6

Starts

2008-04-01

Expected to finish

2009-10-01

Last updated by the study team

2013-01-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• score over 50 on the 0-100 VAS pain scale
• acute, confirmed gout flare for no longer than 3 days

You may not qualify if…

• Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
• Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
• Pregnant or breastfeeding women
• Major surgery with high infection risk
• History of severe allergy to food or drugs
• History or risk of tuberculosis
• Active infection
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigator Site — Birmingham, Alabama, United States
• Novartis Investigator Site — New Brunswick, New Jersey, United States
• Novartis Investigator Site — Lausanne, Switzerland
• Novartis Investigator Site — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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