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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: March 20, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:
  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Week 20 ]
    Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.


Secondary Outcome Measures:
  • Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.

  • Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.

  • Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.

  • Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.


Enrollment: 1315
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
Placebo Comparator: Placebo
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
Other: Placebo
Placebo subcutaneous injection once a week
Experimental: Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Biological: Rilonacept
Rilonacept 160 mg subcutaneous injection once a week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 80 years of age;
  • Previously met the preliminary criteria of American Rheumatism Associatio (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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00856206     History of Changes
Other Study ID Numbers: IL1T-GA-0815
Study First Received: February 21, 2009
Results First Received: March 20, 2017
Last Updated: March 20, 2017

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 September 21, 2017