Clinical Trial: PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Brief Summary: The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Detailed Summary:
Sponsor: Regeneron Pharmaceuticals

Current Primary Outcome: Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]

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. Number of gout flares per participant was reported for this outcome measure.


Original Primary Outcome: number of flares during the treatment period [ Time Frame: 16 Weeks ]

Current Secondary Outcome:

  • Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.
  • Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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.
  • Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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 was reported for this outcome measure.
  • Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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. Number of gout flare days per participant was reported for this outcome measure.
  • Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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.


Original Secondary Outcome:

  • number of modified gout flares per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ]


Information By: Regeneron Pharmaceuticals

Dates:
Date Received: August 11, 2009
Date Started: July 2009
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017