PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00829829
First received: January 23, 2009
Last updated: April 26, 2012
Last verified: April 2012
  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 beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.


Condition Intervention Phase
Intercritical Gout
Drug: rilonacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • number of flares during the treatment period [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of modified gout flares per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 241
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: rilonacept
Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
Active Comparator: 2
rilonacept 80 mg
Drug: rilonacept
rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
Active Comparator: 3
rilonacept 160 mg
Drug: rilonacept
rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks

  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 the ARA for the classification of the acute arthritis of primary gout
  • At least 2 gout flares in the year prior to the Screening Visit
  • Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the Screening Visit or during Screening
  • Persistent chronic or active infections
  • History of an allergic reaction to allopurinol
  • History or presence of cancer within 5 years of the Screening Visit
  • Previous exposure to rilonacept
  • Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829829

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Gilbert, Arizona, United States, 85296
Peoria, Arizona, United States, 85381
United States, Arkansas
Searcy, Arkansas, United States, 72143
United States, California
Concord, California, United States, 94520
San Diego, California, United States, 92103
Santa Maria, California, United States, 93454
United States, Connecticut
Trumball, Connecticut, United States, 06611
United States, District of Columbia
Washington, District of Columbia, United States, 20003
United States, Florida
Daytona Beach, Florida, United States, 32117
Delray Beach, Florida, United States, 33446
Jacksonville, Florida, United States, 32205
Jupiter, Florida, United States, 33458
Naples, Florida, United States, 34102
St. Petersburg, Florida, United States, 33702
United States, Georgia
Gainsville, Georgia, United States, 30501
Rome, Georgia, United States, 30165
Tucker, Georgia, United States, 30084
Woodstock, Georgia, United States, 30188
United States, Idaho
Boise, Idaho, United States, 83713
United States, Indiana
Avon, Indiana, United States, 46123
Evansville, Indiana, United States, 47714
South Bend, Indiana, United States, 46601
United States, Kansas
Wichita, Kansas, United States, 67208
United States, Kentucky
Bowling Green, Kentucky, United States, 42101
Owensboro, Kentucky, United States, 42303
United States, Maryland
Baltimore, Maryland, United States, 21286
Ellicott City, Maryland, United States, 21042
Resistertown, Maryland, United States, 01136
United States, Michigan
Troy, Michigan, United States, 48098
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Florissant, Missouri, United States, 63031
United States, Nevada
Las Vegas, Nevada, United States, 89123
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Berkeley Heights, New Jersey, United States, 07922
Freehold, New Jersey, United States, 07728
United States, New York
Brooklyn, New York, United States, 11201
United States, North Carolina
Greensboro, North Carolina, United States, 27408
Hickory, North Carolina, United States, 28601
Morehead City, North Carolina, United States, 28516
Raleigh, North Carolina, United States, 27607
Raleigh, North Carolina, United States, 27612
Salisbury, North Carolina, United States, 28144
United States, Ohio
Akron, Ohio, United States, 44313
Cincinnati, Ohio, United States, 45246
Middleburg Heights, Ohio, United States, 44130
Perrysburg, Ohio, United States, 43551
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Fountain Hill, Pennsylvania, United States, 18105
Huntingdon Valley, Pennsylvania, United States, 19006
Lancaster, Pennsylvania, United States, 17601
United States, South Carolina
Charleston, South Carolina, United States, 29406
Columbia, South Carolina, United States, 29204
Greer, South Carolina, United States, 29651
North Charleston, South Carolina, United States, 29406
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75224
Houston, Texas, United States, 77074
Longview, Texas, United States, 75605
Richardson, Texas, United States, 75080
San Antonio, Texas, United States, 78229
United States, Virginia
Burke, Virginia, United States, 22015
Richmond, Virginia, United States, 23219
United States, Washington
Spokane, Washington, United States, 99204
Tacoma, Washington, United States, 98405
Canada, Alberta
Calgary, Alberta, Canada, T2X3X7
Canada, British Columbia
Burnaby, British Columbia, Canada, V5G1T4
Kamloops, British Columbia, Canada, V2C1K7
Kelowna, British Columbia, Canada, V1Y3G8
Quesnel, British Columbia, Canada, V2J2K3
Victoria, British Columbia, Canada, V8R 6V4
Canada, Newfoundland and Labrador
Mt. Pearl, Newfoundland and Labrador, Canada, A1N1W7
St. John's, Newfoundland and Labrador, Canada, A1E2E2
Canada, Ontario
Brampton, Ontario, Canada, L6W3E1
Corunna, Ontario, Canada, N0N1G0
Fort Erie, Ontario, Canada, L2A1Z3
Kitchener, Ontario, Canada, N2M5N6
Listowel, Ontario, Canada, N4W2P4
London, Ontario, Canada, N6B2E5
London, Ontario, Canada, N5Z3L2
Mississauga, Ontario, Canada, L5M2V8
Newmarket, Ontario, Canada, L3Y5G8
Sudbury, Ontario, Canada, P3E1H5
Toronto, Ontario, Canada, M9W4L6
Windsor, Ontario, Canada, N8X5A6
Canada, Quebec
Montreal, Quebec, Canada, H1T2M4
Trois-Rivieres, Quebec, Canada, G8Z1YZ
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K0H6
Canada
Quebec, Canada, G1V3M7
Sponsors and Collaborators
Regeneron Pharmaceuticals
  More Information

Additional Information:
No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00829829     History of Changes
Other Study ID Numbers: IL1T-GA-0810
Study First Received: January 23, 2009
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Regeneron Pharmaceuticals:
Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
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
Allopurinol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014