PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
NCT ID: NCT00958438
Last Updated: 2017-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
248 participants
INTERVENTIONAL
2009-07-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Two 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.
Placebo
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
Rilonacept 80 mg
Two 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
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
Rilonacept 160 mg
Two 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.
Rilonacept
Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
Interventions
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Placebo
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
Rilonacept
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
Rilonacept
Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Evans, PharmD
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Berlin, , Germany
Essen, , Germany
Goch, , Germany
Hamburg, , Germany
Kassel, , Germany
Künzing, , Germany
Lollar, , Germany
Magdeburg, , Germany
München, , Germany
Rhaunen, , Germany
Siegen, , Germany
Ahmedabad, , India
Bangalore, , India
Gandhinagar, , India
Hyderabaad, , India
Kolkata, , India
Mangalore, , India
Pune, , India
Secunderabad, , India
Vadodara, , India
Varanasi, , India
Denpasar, , Indonesia
Jakarta, , Indonesia
Kemerdekaan, , Indonesia
Palembang, , Indonesia
Semarang, , Indonesia
South Sulawesi, , Indonesia
West Java, , Indonesia
Yogyakarta, , Indonesia
Benoni, , South Africa
Bloemfontein, , South Africa
Breyten, , South Africa
Cape Town, , South Africa
Dundee, , South Africa
Durban, , South Africa
Durban North, , South Africa
eManzimtoti, , South Africa
Gauteng, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Krugersdorp, , South Africa
KZ-Natal, , South Africa
Lenasia, , South Africa
Lyttleton, , South Africa
Middleburg, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Roodepoort, , South Africa
Scottburgh, , South Africa
Somerset West, , South Africa
Soweto, , South Africa
Worcester, , South Africa
Yungkang City, Tainan, Taiwan
Changhua, , Taiwan
Dalin Town, , Taiwan
Hualien City, , Taiwan
Kaohsiung City, , Taiwan
Kwei-Shan, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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References
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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.
Related Links
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Other Identifiers
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2008-007762-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IL1T-GA-0816
Identifier Type: -
Identifier Source: org_study_id
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