Status:
COMPLETED
Study Utilizing Rilonacept in Gout Exacerbations
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Acute Gout Flare
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this s...
Eligibility Criteria
Inclusion
- Male or female 18 - 70 years of age
- Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
- Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
- Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
- Current presentation of acute gout flare in 3 joints or less
Exclusion
- Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
- Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
- History of NSAID intolerance
- Participants with history of chronic, gouty arthritis
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00855920
Start Date
March 1 2009
End Date
February 1 2010
Last Update
April 28 2017
Active Locations (44)
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1
Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Mesa, Arizona, United States
4
Phoenix, Arizona, United States