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

  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
United States, California
Burbank, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Upland, California, United States
United States, Florida
Brooksville, Florida, United States
Clearwater, Florida, United States
Debary, Florida, United States
Deland, Florida, United States
Jacksonville, Florida, United States
Naples, Florida, United States
Palm Harbor, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Canton, Georgia, United States
Decatur, Georgia, United States
Sandy Springs, Georgia, United States
Stockbridge, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Indiana
Brownsburg, Indiana, United States
Evansville, Indiana, United States
Greenfield, Indiana, United States
United States, Kentucky
Bowling Green, Kentucky, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Michigan
Bingham Farms, Michigan, United States
United States, Minnesota
Brooklyn Center, Minnesota, United States
United States, Missouri
Richmond Heights, Missouri, United States
St. Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
Kalispell, Montana, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Jersey
Elizabeth, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Brooklyn, New York, United States
Mineola, New York, United States
New York, New York, United States
Roslyn, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Hickory, North Carolina, United States
Mooresville, North Carolina, United States
Morganton, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Morrisville, Pennsylvania, United States
Ridley Park, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
United States, South Carolina
Anderson, South Carolina, United States
Monck's Corner, South Carolina, United States
Orangeburg, South Carolina, United States
United States, Tennessee
Johnson City, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Carrollton, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Sugarland, Texas, United States
United States, Utah
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Oak Creek, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Germany
Kuenzing, BY, Germany
Dietzenbach, HE, Germany
Hamburg, HH, Germany
Essen, NW, Germany
Goch, NW, Germany
Siegen, NW, Germany
Rhaunen, RP, Germany
India
Secundrabad, Andh Prad, India
New Dehli, Delhi, India
Ahmedabad, Gujarat, India
Gandhinagar, Gujarat, India
Bangalore, Karna, India
Mangalore, Karna, India
Mumbai, Mahara, India
Kolkatta, W Bengal, India
Indonesia
Denpasar, Bali, Indonesia
Makassar, South Sulawesi, Indonesia
Padang, West Sumatra, Indonesia
Bandung, Indonesia
Daerah Istimewa Yogyakarta, Indonesia
Malang, Indonesia
South Sumatra, Indonesia
South Africa
Port Elizabeth, E Cape, South Africa
Bloemfontein, Free State, South Africa
Benoni, Gauteng, South Africa
Centurion, Gauteng, South Africa
Eldoraigne, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Lenasia, Gauteng, South Africa
Limpopo, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Rustenburg, Gauteng, South Africa
Soweto, Gauteng, South Africa
Dundee, KZ-Natal, South Africa
Durban North, KZ-Natal, South Africa
Phoenix, KZ-Natal, South Africa
Verulam, KZ-Natal, South Africa
Breyten, Mpumalanga, South Africa
Durban, Mpumalanga, South Africa
Cape Town, W Cape, South Africa
Mpumalanga, South Africa
Taiwan
Changhua, Taiwan
Hualien, Taiwan
Tainan, Taiwan
Taipei, Taiwan
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 August 28, 2014