Clinical investigation of medicinal products for the treatment of ankylosing spondylitis

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference numberCPMP/EWP/4891/03
Published23/04/2009
Effective from01/11/2009
KeywordsAnkylosing spondylitis, axial spondyloarthritis, spondyloarthritis, chronic inflammatory diseases
DescriptionThis document provides guidance for the clinical evaluation of new medicinal products for the treatment of ankylosing spondylitis. It addresses the patient characteristics and selection criteria, as well as efficacy assessement. It outlines strategies for early studies in man (dose-response trials) as well as for therapeutic confirmatory trials and specific aspects of evaluation of clinical safety.


Document history

Revision 1

In progress

PDF iconAdopted guideline



PDF iconDraft guideline

PDF iconConcept paper

Published: 31/10/2017
Updated: 13/07/2018
Effective from: 01/05/2018

Published: 01/07/2016

Published: 01/04/2015

First version

Current version

PDF iconAdopted guideline


Overview of comments


PDF iconDraft guideline

In operation: 01/11/2009–present


Published: 23/04/2009


Published: 23/06/2005


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