Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

Gout Attack Clinical Trial

Official title: Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The study was designed as a 14-day, two center- pilot randomized, active-controlled, double-blind, study. The study was approved by the Institutional Review Board (IRB) Pro2018000562. Patients were screened for eligibility at the time of an acute flare. Patients aged 28-55 years with an acute gout flare meeting the validated definition of flare were enrolled (12). Onset of current acute gout flare was within 3 days prior to randomization and baseline pain intensity ≥50 mm on a 0-100 mm visual analogue scale (VAS), Gout patients were defined by a confirmed diagnosis of crystal proven gout and or a score of ≥ 8 on the 2015 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Gout Classification Criteria (13).

Patients recorded pain intensity in the most affected joint prior to treatment. Efficacy, including pain on a 0-100 mm VAS, and safety assessments were conducted at 24 and 72 hours, 7 and 14 days after baseline. ;

Related Conditions & MeSH terms

• Gout
• Gout Attack

• NCT number: NCT03636373
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Terminated
• Phase: Phase 4
• Start date: October 25, 2019
• Completion date: August 13, 2021