Clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis - Scientific guideline

This document provides guidance on the development and evaluation of medicinal products for the chronic treatment of systemic lupus erythematosus in adult and juvenile onset forms. It also addresses the development of medicinal products for the treatment of patients with lupus nephritis.

Keywords: Cutaneous lupus erythematosus (CLE), systemic lupus erythematosus (SLE), discoid lupus erythematosus (DLE), efficacy endpoints, disease activity indices

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis

Adopted Reference Number: EMA/CHMP/51230/2013 Summary:

This document is intended to provide guidance on the clinical investigation of medicinal products for the chronic treatment of systemic lupus erythematosus (SLE), a complex autoimmune disease that can affect multiple organs.

Overview of external comments received on the 'Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, and lupus nephritis'

Reference Number: EMA/37217/2015

Draft guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis

Draft: consultation closed Consultation dates: 05/03/2013 to 04/09/2013 Reference Number: EMA/CHMP/51230/2013 Summary:

This document is intended to provide guidance on the clinical investigation of medicinal products for the treatment of systemic lupus erythematosus (SLE), a complex autoimmune disease that can affect multiple organs.

Concept paper on the need for a guideline on the clinical investigation of medicianl products intended for treatment of systematic and cutaneous lupus erythematosus

Draft: consultation closed Consultation dates: 19/11/2009 to 28/02/2010 Reference Number: EMEA/CHMP/EWP/604040/2009