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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: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Gout
 Drug: Rilonacept
Drug: Placebo
Drug: Allopurinol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 219
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Drug: Rilonacept
Regimen 1
Drug: Allopurinol
Background Treatment
Placebo Comparator: Group 2 Drug: Placebo
Regimen 2
Drug: Allopurinol
Background Treatment

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459796

  Show 74 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01459796     History of Changes
Other Study ID Numbers: IL1T-GA-1101
Study First Received: October 12, 2011
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013