Trial record 13 of 5017 for:    "Genetic Diseases, Inborn" [DISEASE]

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Allopurinol
Metabolic Disease
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 August 18, 2014