drugset

drugset / Trial / NCT00420303

Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

NCT00420303 ↗

Phase 4 Completed 24 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

Timeline

Start: 2007-01
Primary completion: 2008-09
Completion: 2008-09

Outcome

Met primary endpoint

paper significantly greater in the etanercept versus placebo group: -28.5 versus -11.1, respectively (p=0.029). PMID 20511606 ↗

registry MEAN Etanercept: -37.59 (Standard Deviation 22.04) units on scale NCT00420303 ↗

registry analysis (superiority or other test); Etanercept vs Placebo; p = 0.007; ANCOVA NCT00420303 ↗

Publications

Dougados M, Combe B, Braun J, Landewe R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	—

Indications