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

NCT00856206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1315

Last updated 2017-04-28

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Rilonacept

Rilonacept 160 mg subcutaneous injection once a week

OTHER

Placebo

Placebo subcutaneous injection once a week

Sponsors & Collaborators

Principal Investigators

  • Robert Evans, PharmD · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Germany
  • India
  • Indonesia
  • South Africa
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856206 on ClinicalTrials.gov