PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

Last updated: March 20, 2017
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Bone Diseases

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT00958438
IL1T-GA-0816
2008-007762-39
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

  • 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 3months prior to the screening visit.

Study Design

Total Participants: 248
Study Start date:
July 01, 2009
Estimated Completion Date:
December 31, 2010

Connect with a study center

  • Berlin,
    Germany

    Site Not Available

  • Essen,
    Germany

    Site Not Available

  • Goch,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Kassel,
    Germany

    Site Not Available

  • Kuenzing,
    Germany

    Site Not Available

  • Lollar,
    Germany

    Site Not Available

  • Magdeburg,
    Germany

    Site Not Available

  • Muenchen,
    Germany

    Site Not Available

  • Rhaunen,
    Germany

    Site Not Available

  • Siegen,
    Germany

    Site Not Available

  • Ahmedabad,
    India

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  • Bangalore,
    India

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  • Gandhinagar,
    India

    Site Not Available

  • Hyderabaad,
    India

    Site Not Available

  • Kolkatta,
    India

    Site Not Available

  • Mangalore,
    India

    Site Not Available

  • Pune,
    India

    Site Not Available

  • Secunderabad,
    India

    Site Not Available

  • Vadodara,
    India

    Site Not Available

  • Varanasi,
    India

    Site Not Available

  • Denpasar,
    Indonesia

    Site Not Available

  • Jakarta,
    Indonesia

    Site Not Available

  • Kemerdekaan,
    Indonesia

    Site Not Available

  • Palembang,
    Indonesia

    Site Not Available

  • Semarang,
    Indonesia

    Site Not Available

  • South Sulawesi,
    Indonesia

    Site Not Available

  • West Java,
    Indonesia

    Site Not Available

  • Yogyakarta,
    Indonesia

    Site Not Available

  • Amanzimtoti,
    South Africa

    Site Not Available

  • Benoni,
    South Africa

    Site Not Available

  • Bloemfontein,
    South Africa

    Site Not Available

  • Breyton,
    South Africa

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • Dundee,
    South Africa

    Site Not Available

  • Durban,
    South Africa

    Site Not Available

  • Durban North,
    South Africa

    Site Not Available

  • Gauteng,
    South Africa

    Site Not Available

  • Johannesburg,
    South Africa

    Site Not Available

  • KZ-Natal,
    South Africa

    Site Not Available

  • Kempton Park,
    South Africa

    Site Not Available

  • Krugersdorp,
    South Africa

    Site Not Available

  • Lenasia,
    South Africa

    Site Not Available

  • Lyttleton,
    South Africa

    Site Not Available

  • Middleburg,
    South Africa

    Site Not Available

  • Port Elizabeth,
    South Africa

    Site Not Available

  • Pretoria,
    South Africa

    Site Not Available

  • Roodepoort,
    South Africa

    Site Not Available

  • Scottburgh,
    South Africa

    Site Not Available

  • Somerset West,
    South Africa

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  • Soweto,
    South Africa

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  • Worcester,
    South Africa

    Site Not Available

  • Yungkang City, Tainan
    Taiwan

    Site Not Available

  • Changhua,
    Taiwan

    Site Not Available

  • Dalin Town,
    Taiwan

    Site Not Available

  • Hualien,
    Taiwan

    Site Not Available

  • Kaohsiung,
    Taiwan

    Site Not Available

  • Kwei-Shan,
    Taiwan

    Site Not Available

  • Taichung,
    Taiwan

    Site Not Available

  • Tainan,
    Taiwan

    Site Not Available

  • Taipei,
    Taiwan

    Site Not Available

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