Clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Scientific guideline

This is a revision of the Guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis (CPMP/EWP/4891/03) which came into effect in May 2009. It should be considered as general guidance on the development of medicinal products for the treatment of axial spondyloarthritis and should be read in conjunction with other European and ICH guidelines which may apply to this disease area and patient population.

Keywords: Axial spondyloarthritis, regulatory requirements, AS, nonradiographical axial SpA

Current effective version

Guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1

AdoptedReference Number: EMA/CPMP/EWP/4891/03 Rev.1 Corr.Legal effective date: 01/05/2018

Document history

Guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1

AdoptedReference Number: EMA/CPMP/EWP/4891/03 Rev.1 Corr.Legal effective date: 01/05/2018

Draft guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1

Draft: consultation closedConsultation dates: 01/07/2016 to 31/12/2016Reference Number: CPMP/EWP/4891/03Summary:

This document is a revision of the guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis (CPMP/EWP/4891/03) which came into effect in May 2009. It should be considered as general guidance on the development of medicinal products for the treatment of axial spondyloarthritis and should be read in conjunction with other European and ICH guidelines which may apply to this disease area and patient population.

Guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis - First version

AdoptedReference Number: CPMP/EWP/4891/03Legal effective date: 01/11/2009

Draft guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis - First version

Draft: consultation closedReference Number: CPMP/EWP/4891/03

Concept paper on clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1

Draft: consultation closedConsultation dates: 01/04/2015 to 30/06/2015Reference Number: EMA/CHMP/80184/2015Summary:

This concept paper examines the need to update the guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis, addressing issues on adequate patient populations and outcome measures for clinical trials.