Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

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.

Timeline

Start

2019-10-25

Primary completion

2021-08-13

Completion

2021-08-13

Outcome

Missed primary endpoint

Stopped (Enrollment): “The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug”

registry analysis (non-inferiority test); Etanercept vs Triamcinolone Acetonide; p = 1.00; t-test, 1 sided NCT03636373 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Comparator	Triamcinolone Acetonide	Other / unclassified	40 mg	Intramuscular

Indications