Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

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)

Population: Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).

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)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

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)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

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.

Time frame: Day 1 to Day 168 (Week 24)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

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)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

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)

Population: Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).