Status:
COMPLETED
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Lead Sponsor:
Novartis
Conditions:
Arthritis, Gouty
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00663169
Start Date
April 1 2008
End Date
October 1 2009
Last Update
January 7 2013
Active Locations (4)
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1
Novartis Investigator Site
Birmingham, Alabama, United States, 35249
2
Novartis Investigator Site
New Brunswick, New Jersey, United States, 08901
3
Novartis Investigator Site
Lausanne, Switzerland
4
Novartis Investigator Site
Glasgow, United Kingdom