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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610363
First Posted: February 7, 2008
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
January 24, 2008
February 7, 2008
March 20, 2017
May 2, 2017
May 2, 2017
November 2007
October 2008   (Final data collection date for primary outcome measure)
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.
number of flares during the treatment period [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00610363 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gout
  • Biological: Rilonacept
    Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
  • Other: Placebo (for Rilonacept)
    Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
  • 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.
    Intervention: Other: Placebo (for Rilonacept)
  • 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.
    Intervention: Biological: Rilonacept

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00610363
IL1T-GA-0619
Yes
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Shirletta King-Davis Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP