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Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

NCT03636373 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-10-27

Study results available
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Summary

The purpose of this pilot study is to investigate the safety and efficacy of etanercept (Enbrel™; Amgen) for the treatment of an acute gout attack will be non-inferior to triamcinolone acetonide an FDA approved drug to treat acute gout attacks.

Conditions

  • Gout Attack

Interventions

DRUG

Etanercept

Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2

DRUG

Triamcinolone Acetonide

Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Naomi Schlesinger, MD · Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2021-08-13
Completion
2021-08-13
FDA Drug
Yes

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 NCT03636373 on ClinicalTrials.gov