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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Unnamed facility
Number of Gout Flares Per Participant Assessed From Day 1 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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Percentage of Participants With at Least One Gout Flare From Day 1 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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flares Per Month Per Participant From Day 1 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).
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
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San Diego, California, United States
Unnamed facility
Santa Maria, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
Colorado Srings, Colorado, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Ocala, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Tampa, Florida, United States
...and 24 more locations
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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
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)
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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
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)
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.
Time frame: Day 1 (Baseline) to Day 84 (Week 12)