Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain

Phase 4 Completed 108 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.

Timeline

Start: 2006-12
Primary completion: 2008-06
Completion: 2008-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Etanercept BIW vs Etanercept QW; p = 0.6031; Chi-squared NCT00873730 ↗

paper At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). PMID 21700683 ↗

Publications

Navarro-Sarabia F, Fernandez-Sueiro JL, Torre-Alonso JC, Gratacos J, Queiro R, Gonzalez C, Loza E, Linares L, Zarco P, Juanola X, Roman-Ivorra J, Martin-Mola E, Sanmarti R, Mulero J, Diaz G, Armendariz Y, Collantes E. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23.

Drugs

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