Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
1 other identifier
interventional
1,315
6 countries
124
Brief Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedApril 28, 2017
March 1, 2017
1.8 years
February 21, 2009
March 20, 2017
March 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Baseline up to Week 20
Secondary Outcomes (4)
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)
Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least Two 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)
Study Arms (2)
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 160 mg
EXPERIMENTALTwo 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
Eligibility Criteria
You may qualify if:
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
You may not qualify if:
- Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the Screening Visit;;;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
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Alabaster, Alabama, United States
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Mesa, Arizona, United States
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Burbank, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Upland, California, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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DeBary, Florida, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Naples, Florida, United States
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Palm Harbor, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Decatur, Georgia, United States
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Sandy Springs, Georgia, United States
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Stockbridge, Georgia, United States
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Boise, Idaho, United States
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Brownsburg, Indiana, United States
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Evansville, Indiana, United States
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Greenfield, Indiana, United States
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Bowling Green, Kentucky, United States
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Bingham Farms, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Richmond Heights, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Kalispell, Montana, United States
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Lincoln, Nebraska, United States
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Elizabeth, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Roslyn, New York, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Mooresville, North Carolina, United States
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Morganton, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Middleburg Heights, Ohio, United States
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Duncansville, Pennsylvania, United States
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Morrisville, Pennsylvania, United States
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Ridley Park, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Anderson, South Carolina, United States
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Monck's Corner, South Carolina, United States
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Orangeburg, South Carolina, United States
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Johnson City, Tennessee, United States
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Arlington, Texas, United States
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Carrollton, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Sugarland, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Oak Creek, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Künzing, Bavaria, Germany
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Hamburg, Hamburg, Germany
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Dietzenbach, Hesse, Germany
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Essen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Siegen, North Rhine-Westphalia, Germany
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Rhaunen, Rhineland-Palatinate, Germany
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Secundrabad, Andh Prad, India
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Ahmedabad, Gujarat, India
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Gandhinagar, Gujarat, India
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Bangalore, Karna, India
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Mangalore, Karna, India
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Mumbai, Mahara, India
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New Dehli, National Capital Territory of Delhi, India
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Kolkata, West Bengal, India
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Denpasar, Bali, Indonesia
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Makassar, South Sulawesi, Indonesia
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Padang, West Sumatra, Indonesia
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Bandung, Indonesia
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Malang, Indonesia
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South Sumatra, Indonesia
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Yogyakarta, Indonesia
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Port Elizabeth, E Cape, South Africa
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Bloemfontein, Free State, South Africa
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Benoni, Gauteng, South Africa
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Centurion, Gauteng, South Africa
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Eldoraigne, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Kempton Park, Gauteng, South Africa
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Krugersdorp, Gauteng, South Africa
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Lenasia, Gauteng, South Africa
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Limpopo, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Rustenburg, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Dundee, KZ-Natal, South Africa
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Durban North, KZ-Natal, South Africa
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Phoenix, KZ-Natal, South Africa
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Verulam, KZ-Natal, South Africa
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Breyten, Mpumalanga, South Africa
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Durban, Mpumalanga, South Africa
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Cape Town, W Cape, South Africa
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Mpumalanga, South Africa
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Changhua, Taiwan
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Hualien City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
Related Publications (1)
Sundy JS, Schumacher HR, Kivitz A, Weinstein SP, Wu R, King-Davis S, Evans RR. Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study. J Rheumatol. 2014 Aug;41(8):1703-11. doi: 10.3899/jrheum.131226. Epub 2014 Jul 15.
PMID: 25028379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Management
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Robert Evans, PharmD
Regeneron Pharmaceuticals
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
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2009
First Posted
March 5, 2009
Study Start
March 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
April 28, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-03