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: September 27, 2013
Last verified: June 2011

February 13, 2009
September 27, 2013
March 2009
February 2010   (final data collection date for primary outcome measure)
The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00855920 on ClinicalTrials.gov Archive Site
The change from baseline in PAP at Days 2, 3 and 4 [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Same as current
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 is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Gout Flare
  • Drug: rilonacept
    rilonacept 320 mg SC injection at baseline
  • Drug: indomethacin
    oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days)
  • Other: placebo
    oral placebo TID x 12 days
  • Other: placebo
    placebo one time dose
  • Active Comparator: Group 1
    indomethacin and placebo
    Interventions:
    • Drug: indomethacin
    • Other: placebo
  • Active Comparator: Group 2
    rilonacept and indomethacin
    Interventions:
    • Drug: rilonacept
    • Drug: indomethacin
  • Active Comparator: Group 3
    rilonacept and placebo
    Interventions:
    • Drug: rilonacept
    • Other: placebo
Not Provided

*   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 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. Subjects with history of chronic, gouty arthritis
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00855920
IL1T-GA-0814
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2011

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