Clinical investigation of medicinal products for treatment of rheumatoid arthritis - Scientific 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".

Keywords: Rheumatoid arthritis, disease modifying anti-rheumatic drugs, clinical development, CHMP, EMA, guideline

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis

Adopted Reference Number: CPMP/EWP/556/95 Rev. 2 Legal effective date: 01/07/2018

Document history

Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis

Draft: consultation closed Consultation dates: 04/06/2015 to 29/11/2015 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.

Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis

Draft: consultation closed Consultation dates: 05/12/2011 to 05/06/2012 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)

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

Draft: consultation closed Consultation dates: 20/01/2010 to 30/04/2010 Reference Number: EMA/CHMP/EWP/751552/2009

Points to consider on clinical investigation of medicinal products other than nsaids for treatment of rheumatoid arthritis

Adopted Reference Number: CPMP/EWP/556/95 rev 1/Final Legal effective date: 01/06/2004