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
Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis
Adopted Legal effective date: 01/07/2018 Reference Number: CPMP/EWP/556/95 Rev. 2English (EN) (202.64 KB - PDF)
First published: 10/01/2018 Last updated: 10/01/2018Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis
Consultation dates: 04/06/2015 to 29/11/2015 Draft: consultation closed Reference Number: CPMP/EWP/556/95 Rev. 2 Summary:
This document is intended to provide guidance on the clinical evaluation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of rheumatoid arthritis (RA). RA is a chronic systemic inflammatory disease of synovial joints and other organ systems. If left untreated, it causes joint destruction, deformity and functional impairment.
English (EN) (189.38 KB - PDF)
First published: 04/06/2015 Last updated: 04/06/2015Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis
Consultation dates: 05/12/2011 to 05/06/2012 Draft: consultation closed Reference Number: CPMP/EWP/556/95 Rev. 2 Summary:
This guideline replaces the points to consider on the clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs in rheumatoid arthritis (CPMP/EWP/556/95 rev. 1)
English (EN) (279.78 KB - PDF)
First published: 20/12/2011 Last updated: 20/12/2011Concept paper on the need for revision of the points to consider on the clinical investigation of medicinal products other than nsaids in rheumatoid arthritis
Consultation dates: 20/01/2010 to 30/04/2010 Draft: consultation closed Reference Number: EMA/CHMP/EWP/751552/2009
English (EN) (118.99 KB - PDF)