Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00856206
First received: February 21, 2009
Last updated: December 1, 2011
Last verified: December 2011

February 21, 2009
December 1, 2011
March 2009
January 2011   (final data collection date for primary outcome measure)
Safety assessed by summarizing the incidences and types of treatment emergent adverse events and lab parameter changes. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00856206 on ClinicalTrials.gov Archive Site
Number of gout flares from Day 1 to Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Gout
  • Biological: Rilonacept
    160mg once a week
  • Other: Placebo
    Placebo once a week
  • Experimental: 1
    Rilonacept 320 mg SC loading dose followed by 160 mg SC weekly for 16 weeks.
    Intervention: Biological: Rilonacept
  • Placebo Comparator: 2
    Placebo SC loading dose followed by placebo SC weekly for 16 weeks
    Intervention: 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
1274
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female 18 to 80 years of age
  • Previously met the preliminary criteria of ARA for the classification of acute gout arthritis of primary gout
  • Subjects with history of gout, initiating or currently on urate lowering therapy who are at risk of gout flare

Exclusion Criteria:

  • Acute gout flare within 2 weeks prior to the Screening Visit and during the screening visit
  • Persistent chronic or active infections
  • History of an allergic reaction to allopurinol
  • History or presence of cancer within 5 years of the Screening Visit
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   India,   Indonesia,   South Africa,   Taiwan
 
NCT00856206
IL1T-GA-0815
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
December 2011

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