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

HumanScientific guidelines

Italian is available via eTranslation, the European Commission's machine translation service.

Translate to Italian | Important information about machine translation

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 - under revision (see below)

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

Adopted Reference Number: CHMP/EWP/438/04 Legal effective date:

English (EN) (128.15 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Document history - Revision 1

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1

Draft: consultation closed Consultation dates: to Reference Number: CHMP/EWP/438/04 Rev. 1 Summary:

This guideline replaces 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.

English (EN) (424.23 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Document history - First version

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/96250/2024 Summary:

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.

English (EN) (197.07 KB - PDF)

Pubblicato per la prima volta:
Visualizza

Overview of comments received on draft guideline on psoriatic arthritis

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

English (EN) (104.59 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

Draft: consultation closed Reference Number: CPMP/EWP/438/04

English (EN) (116.53 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Share this page