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

NCT00958438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2017-04-28

Study results available
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Summary

The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Conditions

Interventions

DRUG

Placebo

Placebo loading dose followed by placebo subcutaneous (SC) injection (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.

Sponsors & Collaborators

Principal Investigators

  • Robert Evans, PharmD · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Germany
  • India
  • Indonesia
  • South Africa
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00958438 on ClinicalTrials.gov