Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: February 21, 2009
Last updated: December 1, 2011
Last verified: December 2011

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.

Condition Intervention Phase
Biological: Rilonacept
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety assessed by summarizing the incidences and types of treatment emergent adverse events and lab parameter changes. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of gout flares from Day 1 to Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 1274
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rilonacept 320 mg SC loading dose followed by 160 mg SC weekly for 16 weeks.
Biological: Rilonacept
160mg once a week
Placebo Comparator: 2
Placebo SC loading dose followed by placebo SC weekly for 16 weeks
Other: Placebo
Placebo once a week


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 18 to 80 years of age
  • Previously met the preliminary criteria of 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00856206

  Show 124 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00856206     History of Changes
Other Study ID Numbers: IL1T-GA-0815
Study First Received: February 21, 2009
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
South Africa: Medicines Control Council
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Regeneron Pharmaceuticals:
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metabolic Disease
Musculoskeletal Diseases
Joint Diseases
Rheumatic Diseases
Metabolic disorder
Purine Pyrimidine Metabolism, Inborn Errors
Intercritical Gout

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases processed this record on April 14, 2014