The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time frame: Day 1 to Day 392 (Week 56)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
Time frame: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
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Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
Unnamed facility
Sierra Vista, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
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Searcy, Arkansas, United States
Unnamed facility
Concord, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Long Beach, California, United States
...and 64 more locations
Time frame: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Time frame: Day 1 to Day 364 (Week 52)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Time frame: Day 1 to Day 364 (Week 52)
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
Time frame: Day 1 to Day 364 (Week 52)