PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
PRE-SURGE1
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
1 other identifier
interventional
241
2 countries
91
Brief Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2009
Shorter than P25 for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedApril 28, 2017
March 1, 2017
1.2 years
January 23, 2009
March 20, 2017
March 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.
Day 1 to Day 112 (Week 16)
Secondary Outcomes (5)
Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Study Arms (3)
Placebo
PLACEBO COMPARATORTwo subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
Rilonacept 80 mg
ACTIVE COMPARATORTwo subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Rilonacept 160 mg
ACTIVE COMPARATORTwo subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Interventions
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
Eligibility Criteria
You may qualify if:
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification; of the acute arthritis of primary gout;
- At least 2 gout flares in the year prior to the screening visit;
- Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
You may not qualify if:
- Acute gout flare within 2 weeks of the screening visit or during screening;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the screening visit;
- Previous exposure to Rilonacept;
- Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Gilbert, Arizona, 85296, United States
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Peoria, Arizona, 85381, United States
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Searcy, Arkansas, 72143, United States
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Concord, California, 94520, United States
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San Diego, California, 92103, United States
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Santa Maria, California, 93454, United States
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Trumball, Connecticut, 06611, United States
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Washington D.C., District of Columbia, 20003, United States
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Daytona Beach, Florida, 32117, United States
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Delray Beach, Florida, 33446, United States
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Jacksonville, Florida, 32205, United States
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Jupiter, Florida, 33458, United States
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Naples, Florida, 34102, United States
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St. Petersburg, Florida, 33702, United States
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Gainsville, Georgia, 30501, United States
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Rome, Georgia, 30165, United States
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Tucker, Georgia, 30084, United States
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Woodstock, Georgia, 30188, United States
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Boise, Idaho, 83713, United States
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Avon, Indiana, 46123, United States
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Evansville, Indiana, 47714, United States
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South Bend, Indiana, 46601, United States
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Wichita, Kansas, 67208, United States
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Bowling Green, Kentucky, 42101, United States
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Owensboro, Kentucky, 42303, United States
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Baltimore, Maryland, 21286, United States
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Ellicott City, Maryland, 21042, United States
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Resistertown, Maryland, 01136, United States
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Troy, Michigan, 48098, United States
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Jackson, Mississippi, 39202, United States
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Florissant, Missouri, 63031, United States
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Las Vegas, Nevada, 89123, United States
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Las Vegas, Nevada, 89146, United States
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Berkeley Heights, New Jersey, 07922, United States
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Freehold, New Jersey, 07728, United States
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Brooklyn, New York, 11201, United States
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Greensboro, North Carolina, 27408, United States
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Hickory, North Carolina, 28601, United States
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Morehead City, North Carolina, 28516, United States
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Raleigh, North Carolina, 27607, United States
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Raleigh, North Carolina, 27612, United States
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Salisbury, North Carolina, 28144, United States
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Akron, Ohio, 44313, United States
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Cincinnati, Ohio, 45246, United States
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Middleburg Heights, Ohio, 44130, United States
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Perrysburg, Ohio, 43551, United States
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Duncansville, Pennsylvania, 16635, United States
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Fountain Hill, Pennsylvania, 18105, United States
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Huntingdon Valley, Pennsylvania, 19006, United States
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Lancaster, Pennsylvania, 17601, United States
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Charleston, South Carolina, 29406, United States
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Columbia, South Carolina, 29204, United States
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Greer, South Carolina, 29651, United States
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North Charleston, South Carolina, 29406, United States
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Rock Hill, South Carolina, 29732, United States
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Memphis, Tennessee, 38120, United States
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Dallas, Texas, 75224, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77074, United States
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Longview, Texas, 75605, United States
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Richardson, Texas, 75080, United States
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San Antonio, Texas, 78229, United States
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Burke, Virginia, 22015, United States
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Richmond, Virginia, 23219, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Calgary, Alberta, T2X3X7, Canada
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Burnaby, British Columbia, V5G1T4, Canada
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Kamloops, British Columbia, V2C1K7, Canada
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Kelowna, British Columbia, V1Y3G8, Canada
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Quesnel, British Columbia, V2J2K3, Canada
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Victoria, British Columbia, V8R 6V4, Canada
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Mount Pearl, Newfoundland and Labrador, A1N1W7, Canada
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St. John's, Newfoundland and Labrador, A1E2E2, Canada
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Brampton, Ontario, L6W3E1, Canada
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Corunna, Ontario, N0N1G0, Canada
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Fort Erie, Ontario, L2A1Z3, Canada
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Greater Sudbury, Ontario, P3E1H5, Canada
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Kitchener, Ontario, N2M5N6, Canada
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Listowel, Ontario, N4W2P4, Canada
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London, Ontario, N5Z3L2, Canada
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London, Ontario, N6B2E5, Canada
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Mississauga, Ontario, L5M2V8, Canada
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Newmarket, Ontario, L3Y5G8, Canada
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Toronto, Ontario, M9W4L6, Canada
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Windsor, Ontario, N8X5A6, Canada
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Montreal, Quebec, H1T2M4, Canada
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Québec, Quebec, G1V3M7, Canada
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Trois-Rivières, Quebec, G8Z1YZ, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K0H6, Canada
Related Publications (1)
Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.
PMID: 22549879DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Management
- Organization
- Regeneron Pharmaceuticals, Inc. Phone:
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2009
First Posted
January 27, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
April 28, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-03