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Study Utilizing Rilonacept in Gout Exacerbations

NCT00855920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2017-04-28

Study results available
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Summary

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Conditions

  • Acute Gout Flare

Interventions

DRUG

Rilonacept

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).

DRUG

Indomethacin

Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

OTHER

Placebo (for Indomethacin)

Placebo (for Indomethacin) orally TID for 12 days.

OTHER

Placebo (for Rilonacept)

Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

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 NCT00855920 on ClinicalTrials.gov