Clinical investigation of medicinal products for treatment of rheumatoid arthritis - Scientific guideline
Table of contents
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".
Keywords: Rheumatoid arthritis, disease modifying anti-rheumatic drugs, clinical development, CHMP, EMA, guideline
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Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis (PDF/189.38 KB)
Draft: consultation closed
First published: 04/06/2015
Last updated: 04/06/2015
Consultation dates: 04/06/2015 to 29/11/2015
CPMP/EWP/556/95 Rev. 2 -
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Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis (PDF/279.78 KB)
Draft: consultation closed
First published: 20/12/2011
Last updated: 20/12/2011
Consultation dates: 05/12/2011 to 05/06/2012
CPMP/EWP/556/95 Rev. 2 -
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Concept paper on the need for revision of the points to consider on the clinical investigation of medicinal products other than nsaids in rheumatoid arthritis (PDF/118.99 KB)
Draft: consultation closed
First published: 01/02/2010
Last updated: 01/02/2010
Consultation dates: 20/01/2010 to 30/04/2010
EMA/CHMP/EWP/751552/2009 -
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Points to consider on clinical investigation of medicinal products other than nsaids for treatment of rheumatoid arthritis (PDF/175.47 KB)
Adopted
First published: 17/12/2003
Last updated: 17/12/2003
Legal effective date: 01/06/2004
CPMP/EWP/556/95 rev 1/Final