Status:
COMPLETED
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Lead Sponsor:
Novartis
Conditions:
Acute Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs a...
Eligibility Criteria
Inclusion
- History of at least 1 gout flare prior to the Screening Visit
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
- Presence of acute gout flare for no longer than 5 days.
- Baseline pain intensity \> or = to 50 mm on the 0-100 mm VAS.
- Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.
Exclusion
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Presence of severe renal function impairment
- Contraindication to intramuscular injection
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
- Evidence of active pulmonary disease
- Live vaccinations within 3 months prior to the start of the study
- Use of forbidden therapy
- Other protocol-defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00798369
Start Date
November 1 2008
End Date
August 1 2009
Last Update
April 10 2012
Active Locations (75)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207-5710
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Associated Pharmaceutical Research
Buena Park, California, United States, 90620
4
Northern California Institute for Bone Health
Oakland, California, United States, 94609