Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00856206
First received: February 21, 2009
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Gout
 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:

Drug Information available for: Rilonacept
U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00856206

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov 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:
Metabolism, Inborn Errors
Allopurinol
Metabolic Disease
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
 Arthritis
Rheumatic Diseases
Metabolic disorder
Purine Pyrimidine Metabolism, Inborn Errors
Gout
Intercritical Gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013