Clinical Trial: Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
Brief Summary: The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
Detailed Summary:
Sponsor: Regeneron Pharmaceuticals
Current Primary Outcome: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Week 20 ]
Original Primary Outcome: Safety assessed by summarizing the incidences and types of treatment emergent adverse events and lab parameter changes. [ Time Frame: 16 weeks ]
Current Secondary Outcome:
- Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]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 112 were counted, regardless whether the flares occurred during the treatment period or not.
- Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]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. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.
- Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]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. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.
- Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (Week 16) ]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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
Original Secondary Outcome: Number of gout flares from Day 1 to Week 16 [ Time Frame: 16 weeks ]
Information By: Regeneron Pharmaceuticals
Dates:
Date Received: February 21, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017