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

This guideline is under review, see concept paper below.

This guideline provides guidance on the clinical evaluation of the clinical investigation of medicinal products for the treatment of psoriatic arthritis. It describes patient characteristics and selection, methods to assess efficacy and safety as well as strategy and design of clinical trials.

Keywords: psoriatic arthritis, treat-to target, extra musculoskeletal disease manifestations, guidance

Current effective version

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

AdoptedLegal effective date: 01/07/2007Reference Number: CHMP/EWP/438/04

Document history

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

Consultation dates: 01/07/2024 to 30/09/2024Draft: consultation openReference Number: EMA/CHMP/96250/2024Summary:

The proposed guideline will replace the Guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis (CHMP/EWP/438/04).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Overview of comments received on draft guideline on psoriatic arthritis

Reference Number: EMEA/CHMP/EWP/487962/2006

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis

Draft: consultation closedReference Number: CPMP/EWP/438/04