Clinical investigation of medicinal products for the treatment of ankylosing spondylitis

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCPMP/EWP/4891/03
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

Adopted guideline

Draft guideline 

Concept 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

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/11/2009–present

Published: 23/04/2009

Published: 23/06/2005

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