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PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00829829
First received: January 23, 2009
Last updated: April 26, 2012
Last verified: April 2012

January 23, 2009
April 26, 2012
February 2009
May 2010   (final data collection date for primary outcome measure)
number of flares during the treatment period [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00829829 on ClinicalTrials.gov Archive Site
  • number of modified gout flares per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • number of modified gout flares per subject from Day 1 to Week 16 (a gout flare for this analysis will be defined as subject reported articular pain typical of a gout attack that is deemed to require treatment with an anti-inflammatory agent) [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
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

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 beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced 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
Intercritical Gout
  • Drug: rilonacept
    Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
  • Drug: rilonacept
    rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
  • Drug: rilonacept
    rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: rilonacept
  • Active Comparator: 2
    rilonacept 80 mg
    Intervention: Drug: rilonacept
  • Active Comparator: 3
    rilonacept 160 mg
    Intervention: Drug: rilonacept
Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
June 2010
May 2010   (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 the ARA for the classification of the acute arthritis of primary gout
  • At least 2 gout flares in the year prior to the Screening Visit
  • Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the Screening Visit or during Screening
  • Persistent chronic or active infections
  • History of an allergic reaction to allopurinol
  • History or presence of cancer within 5 years of the Screening Visit
  • Previous exposure to rilonacept
  • Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00829829
IL1T-GA-0810
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Not Provided
Regeneron Pharmaceuticals
April 2012

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