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

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).

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)

Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).