Clinical investigation of medicinal products for treatment of rheumatoid arthritis

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Current effective version

Revision 2 - Adopted guideline

Revision 2 enters into effect 01/07/2018 - see below

Reference numberCPMP/EWP/556/95 Rev. 2
Effective from01/07/2018
KeywordsRheumatoid arthritis, disease modifying anti-rheumatic drugs, clinical development, CHMP, EMA, guideline

This document is intended to provide guidance on the clinical evaluation of medicinal products in the treatment of rheumatoid arthritis (RA). 

*The guideline has been formerly known as "Clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis".

Document history

Revision 2 

Current version

Adopted guideline


Draft guideline

Draft guideline

Concept paper

Published: 10/01/2018
Effective from: 01/07/2018


Published: 04/06/2015

Published: 20/12/2011

Published: 01/02/2010

Revision 1


Points to considerIn operation: 01/06/2004–present

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