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Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00610363
First received: January 24, 2008
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.

Condition Intervention Phase
Gout
Biological: Rilonacept
Other: Placebo (for Rilonacept)
Phase 2

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, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During 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 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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 84 were counted, regardless whether the flares occurred during the treatment period or not.


Secondary Outcome Measures:
  • Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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.

  • Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).

  • Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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. Mean number of gout flare days per participant was reported for this outcome measure.

  • Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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. Mean number of gout flare days per month 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 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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 154) 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 154), 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.

  • Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12) [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]
    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: 83
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (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 16.
Other: Placebo (for Rilonacept)
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
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 16.
Biological: Rilonacept
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.

  Eligibility

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

Inclusion Criteria:

  • Male or female greater than 18 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.

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the screening visit and 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.
  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: NCT00610363

  Hide Study Locations
Locations
United States, California
San Diego, California, United States, 92108
Santa Maria, California, United States, 93454
Whittier, California, United States, 90601
United States, Colorado
Colorado Srings, Colorado, United States, 80910
United States, Florida
DeLand, Florida, United States, 32720
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32804
St. Petersburg, Florida, United States, 33710
Tampa, Florida, United States, 33614
Tampa, Florida, United States
United States, Georgia
Dunwoody, Georgia, United States, 30338
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Idaho
Boise, Idaho, United States, 83702
United States, Indiana
Indianapolis, Indiana, United States, 46268
South Bend, Indiana, United States, 46601
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Maryland
Wheaton, Maryland, United States, 20902
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Reno, Nevada, United States, 89502
United States, New York
Albany, New York, United States, 12206
Plainview, New York, United States, 11803
Roslyn, New York, United States, 11576
United States, North Carolina
Monroe, North Carolina, United States, 28112
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45242
Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Charleston, South Carolina, United States, 29406
Grenville, South Carolina, United States, 29601
United States, Texas
Dallas, Texas, United States, 75235
United States, Washington
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Shirletta King-Davis Regeneron Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00610363     History of Changes
Other Study ID Numbers: IL1T-GA-0619
Study First Received: January 24, 2008
Results First Received: March 20, 2017
Last Updated: March 20, 2017

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 May 25, 2017