Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01459796
First received: October 12, 2011
Last updated: September 27, 2013
Last verified: November 2012

October 12, 2011
September 27, 2013
November 2011
June 2013   (final data collection date for primary outcome measure)
Summary of TEAEs (Treatment-Emergent Adverse Events) [ Time Frame: day 1 to week 56 ] [ Designated as safety issue: Yes ]
Safety as assessed by summarizing the incidences and types of treatment-emergent adverse events (TEAEs) and changes in laboratory parameters from day 1 to wk 56
Same as current
Complete list of historical versions of study NCT01459796 on ClinicalTrials.gov Archive Site
  • Proportion of patients with 1 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with 1 or more gout flares from day 1 to wk 52 [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with 2 or more gout flares from day 1 to wk 52. [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with 2 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
  • • Proportion of patients with 1 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
  • • Proportion of patients with 1 or more gout flares from day 1 to wk 52 [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
  • • Proportion of patients with 2 or more gout flares from day 1 to wk 52. [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
  • • Proportion of patients with 2 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

The purpose of this study is to determine the safety and tolerability of rilonacept for patients with gout who are initiating allopurinol.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gout
  • Drug: Rilonacept
    Regimen 1
  • Drug: Placebo
    Regimen 2
  • Drug: Allopurinol
    Background Treatment
  • Active Comparator: Group 1
    Interventions:
    • Drug: Rilonacept
    • Drug: Allopurinol
  • Placebo Comparator: Group 2
    Interventions:
    • Drug: Placebo
    • Drug: Allopurinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
219
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Key Inclusion criteria:

  • Male or female patients aged 18 to 80 years
  • Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout
  • Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit
  • A self-reported history of at least 2 gout flares in the year prior to screening

Exclusion Criteria:

Key Exclusion criteria:

  • Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug
  • Patients requiring dialysis
  • Patients who have had an organ transplant
  • Persistent chronic or active infections
  • Previous exposure to rilonacept
  • Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days 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
 
NCT01459796
IL1T-GA-1101
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
November 2012

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