Clinical Trial: Study Utilizing Rilonacept in Gout Exacerbations

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

Official Title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

Brief Summary: This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Detailed Summary:
Sponsor: Regeneron Pharmaceuticals

Current Primary Outcome: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours [ Time Frame: Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends ]

Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).


Original Primary Outcome: The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours [ Time Frame: 72 hours ]

Current Secondary Outcome:

  • Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours [ Time Frame: Baseline (Day 1) to 72 hours ]
    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
  • Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours [ Time Frame: Baseline (Day 1) to 48 hours ]
    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
  • Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours [ Time Frame: Baseline (Day 1) to 24 hours ]
    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.


Original Secondary Outcome: The change from baseline in PAP at Days 2, 3 and 4 [ Time Frame: 4 days ]

Information By: Regeneron Pharmaceuticals

Dates:
Date Received: February 13, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017