PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00958438
First received: August 11, 2009
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Gout
Drug: placebo
Drug: rilonacept
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • number of flares during the treatment period [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 244
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: placebo
Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
Active Comparator: 2
rilonacept 80 mg
Drug: rilonacept
rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
Active Comparator: 3
rilonacept 160 mg
Drug: rilonacept
rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958438

  Show 61 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
  More Information

Additional Information:
No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00958438     History of Changes
Other Study ID Numbers: IL1T-GA-0816, 2008-007762-39
Study First Received: August 11, 2009
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Taiwan: Department of Health

Keywords provided by Regeneron Pharmaceuticals:
Genetic Diseases, Inborn
Intercritical Gout
Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

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

ClinicalTrials.gov processed this record on August 26, 2014