Study Utilizing Rilonacept in Gout Exacerbations

Condition(s) targeted: Acute Gout Flare

Intervention: placebo and indomethacin (Drug); rilonacept and indomethacin (Drug); rilonacept and placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Regeneron Pharmaceuticals

Official(s) and/or principal investigator(s):
Robert Evans, PharmD, Study Director, Affiliation: Regeneron Pharmaceuticals

Overall contact:
Robert Evans, Phone: 9143457400, Ext: 7782, Email: robert.evans@regeneron.com

This purpose of this clinical research is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.

Official title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours

Secondary outcome: The change from baseline in PAP at Days 2, 3 and 4

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female 18 - 70 years of age

2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout

3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity

4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint

5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

1. Treatment with any 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.

2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments

3. History of NSAID intolerance

4. Subjects with history of chronic, gouty arthritis

Robert Evans, Phone: 9143457400, Ext: 7782, Email: robert.evans@regeneron.com

Birmingham, Alabama, United States; Recruiting

Huntsville, Alabama, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Sierra Vista, Arizona, United States; Recruiting

Mesa, Arizona, United States; Recruiting

Whittier, California, United States; Recruiting

Burbank, California, United States; Recruiting

Orlando, Florida, United States; Recruiting

Debary, Florida, United States; Recruiting

Deland, Florida, United States; Recruiting

Orange Park, Florida, United States; Recruiting

Oviedo, Florida, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Jupiter, Florida, United States; Recruiting

Boise, Idaho, United States; Recruiting

Elizabethtown, Kentucky, United States; Recruiting

Wheaton, Maryland, United States; Recruiting

Baltimore, Maryland, United States; Recruiting

Detroit, Michigan 48221, United States; Recruiting

Stevenville, Michigan, United States; Recruiting

Billings, Montana, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

Albany, New York, United States; Recruiting

Raleigh, North Carolina 27612, United States; Recruiting

Wilmington, North Carolina, United States; Recruiting

Burlington, North Carolina, United States; Recruiting

Raleigh, North Carolina, United States; Recruiting

Cary, North Carolina, United States; Recruiting

Willoughby Hills, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Lake Oswego, Oregon, United States; Recruiting

Portland, Oregon, United States; Recruiting

Johnstown, Pennsylvania, United States; Recruiting

Limerick, Pennsylvania, United States; Recruiting

Norristown, Pennsylvania, United States; Recruiting

Greenville, South Carolina, United States; Recruiting

Bristol, Tennessee, United States; Recruiting

Irving, Texas, United States; Recruiting

North Richland Hills, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Forth Worth, Texas, United States; Recruiting

Mesquite, Texas, United States; Recruiting

Rilonacept

Starting date: March 2009
Ending date: April 2010
Last updated: May 19, 2009