PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
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
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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
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| 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 June 17, 2013