Clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Scientific guideline

This document provides guidelines for the evaluation of medicinal products in juvenile idiopathic arthritis. It addresses specific issues related to the design of clinical studies, extrapolation of efficacy from other age groups and corresponding arthritis diagnoses, and assessment of disease activity.

Keywords: Juvenile idiopathic arthritis, systemic juvenile idiopatic arthritis, oligoarthritis, polyarthritis, enthesitis related arthritis, extrapolation

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Revision 2

Adopted Reference Number: EMA/CHMP/239770/2014 Rev. 2 Summary:

Juvenile idiopathic arthritis (JIA) is currently grouped in multiple categories some of which have counterparts in the more frequent adult diseases of rheumatoid arthritis (RA), axial spondyloarthritis and psoriatic arthritis (PsA) although with considerable differences in phenotype at different ages. Since the Paediatric Regulation came into force, several paediatric investigation plans (PIPs) for new and authorised treatments in adults have been evaluated by the Paediatric Committee (PDCO).

Document history - Revision 2 (current version)

Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Revision 2

Adopted Reference Number: EMA/CHMP/239770/2014 Rev. 2 Summary:

Juvenile idiopathic arthritis (JIA) is currently grouped in multiple categories some of which have counterparts in the more frequent adult diseases of rheumatoid arthritis (RA), axial spondyloarthritis and psoriatic arthritis (PsA) although with considerable differences in phenotype at different ages. Since the Paediatric Regulation came into force, several paediatric investigation plans (PIPs) for new and authorised treatments in adults have been evaluated by the Paediatric Committee (PDCO).

Overview of comments received on the 'Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis'

Reference Number: EMA/CHMP/738839/2015

Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Revision 2

Draft: consultation closed Consultation dates: 15/05/2014 to 15/11/2014 Reference Number: EMA/CHMP/239770/2014 Rev. 2 Summary:

The proposed guideline will replace the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (CPMP/EWP/422/04)

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis

Draft: consultation closed Consultation dates: 01/10/2012 to 15/12/2012 Reference Number: EMA/CHMP/520782/2012 Summary:

The current guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (JIA) was adopted in 2006. Since then there have been major advances in the understanding of the pathophysiology of JIA subtypes, along with the introduction of new treatments including biological therapies. An update of the current JIA guideline is required to reflect these recent advances.

Document history - First version

Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version

Adopted Reference Number: CPMP/EWP/422/04 Legal effective date: 01/05/2007

Overview of comments received on draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version

Reference Number: EMEA/CHMP/EWP/392476/2006

Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version

Draft: consultation closed Reference Number: CPMP/EWP/422/04