PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
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
2 other identifiers
interventional
248
5 countries
61
Brief Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was 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 Jul 2009
61 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
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedApril 28, 2017
March 1, 2017
1.4 years
August 11, 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 113 (Week 16)
Gout flare was defined as 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.
Day 1 to Day 113 (Week 16)
Secondary Outcomes (5)
Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)
Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)
Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)
Day 1 to Day 113 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)
Day 1 to Day 113 (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 113 (Week 16)
Day 1 to Day 113 (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
EXPERIMENTALTwo 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
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
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week 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 (61)
Unknown Facility
Berlin, Germany
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Essen, Germany
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Goch, Germany
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Hamburg, Germany
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Kassel, Germany
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Künzing, Germany
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Lollar, Germany
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Magdeburg, Germany
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München, Germany
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Rhaunen, Germany
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Siegen, Germany
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Ahmedabad, India
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Bangalore, India
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Gandhinagar, India
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Hyderabaad, India
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Kolkata, India
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Mangalore, India
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Pune, India
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Secunderabad, India
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Vadodara, India
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Varanasi, India
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Denpasar, Indonesia
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Jakarta, Indonesia
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Kemerdekaan, Indonesia
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Palembang, Indonesia
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Semarang, Indonesia
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South Sulawesi, Indonesia
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West Java, Indonesia
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Yogyakarta, Indonesia
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Benoni, South Africa
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Bloemfontein, South Africa
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Breyten, South Africa
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Cape Town, South Africa
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Dundee, South Africa
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Durban, South Africa
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Durban North, South Africa
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eManzimtoti, South Africa
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Gauteng, South Africa
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Johannesburg, South Africa
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Kempton Park, South Africa
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Krugersdorp, South Africa
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KZ-Natal, South Africa
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Lenasia, South Africa
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Lyttleton, South Africa
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Middleburg, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Roodepoort, South Africa
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Scottburgh, South Africa
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Somerset West, South Africa
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Soweto, South Africa
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Worcester, South Africa
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Yungkang City, Tainan, Taiwan
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Changhua, Taiwan
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Dalin Town, Taiwan
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Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Kwei-Shan, Taiwan
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Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Related Publications (1)
Mitha E, Schumacher HR, Fouche L, Luo SF, Weinstein SP, Yancopoulos GD, Wang J, King-Davis S, Evans RR. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. Epub 2013 Mar 13.
PMID: 23485476DERIVED
Related Links
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
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2009
First Posted
August 13, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 28, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-03