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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: March 20, 2017
Last verified: March 2017
  Purpose
The purpose of this clinical research study was 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 Other: Placebo Drug: Rilonacept 80 mg Drug: Rilonacept 160 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 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.


Secondary Outcome Measures:
  • Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.

  • Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    Gout flare was defined as 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.

  • Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    Gout flare was defined as 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 flares was reported for this outcome measure.

  • Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    Gout flare was defined as 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 flare days per participant was reported for this outcome measure.

  • Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]
    Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.


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: 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 loading dose followed by placebo injections (2 mL) qw for 16 weeks.
Active Comparator: Rilonacept 80 mg
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Drug: Rilonacept 80 mg
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
Active Comparator: 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.
Drug: Rilonacept 160 mg
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.

  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 the American Rheumatism Association (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
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: 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, 75224
Dallas, Texas, United States, 75231
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, N5Z3L2
London, Ontario, Canada, N6B2E5
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:
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
Results First Received: March 20, 2017
Last Updated: March 20, 2017

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017