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Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00855920
First received: February 13, 2009
Last updated: March 20, 2017
Last verified: March 2017

February 13, 2009
March 20, 2017
March 2009
February 2010   (Final data collection date for primary outcome measure)
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).
The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT00855920 on ClinicalTrials.gov Archive Site
  • 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.
The change from baseline in PAP at Days 2, 3 and 4 [ Time Frame: 4 days ]
Not Provided
Not Provided
 
Study Utilizing Rilonacept in Gout Exacerbations
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Acute Gout Flare
  • Drug: Rilonacept
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
  • Drug: Indomethacin
    Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
  • Other: Placebo (for Indomethacin)
    Placebo (for Indomethacin) orally TID for 12 days.
  • Other: Placebo (for Rilonacept)
    Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
  • Active Comparator: Placebo (for Rilonacept) and Indomethacin
    Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
    Interventions:
    • Drug: Indomethacin
    • Other: Placebo (for Rilonacept)
  • Active Comparator: Rilonacept and Indomethacin
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
    Interventions:
    • Drug: Rilonacept
    • Drug: Indomethacin
  • Active Comparator: Rilonacept and Placebo (for Indomethacin)
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
    Interventions:
    • Drug: Rilonacept
    • Other: Placebo (for Indomethacin)
Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female 18 - 70 years of age
  2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
  3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
  4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
  5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

  1. Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
  2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
  3. History of NSAID intolerance
  4. Participants with history of chronic, gouty arthritis
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00855920
IL1T-GA-0814
Yes
Not Provided
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP