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

NCT01459796 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-07-18

Study results available
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Summary

The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Conditions

Interventions

DRUG

Rilonacept

Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.

DRUG

Placebo

Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.

DRUG

Allopurinol

Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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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 NCT01459796 on ClinicalTrials.gov