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

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/51230/2013
Published27/03/2015
Effective from01/09/2015
KeywordsCutaneous lupus erythematosus (CLE), systemic lupus erythematosus (SLE), discoid lupus erythematosus (DLE), efficacy endpoints, disease activity indices
DescriptionThis 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.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/09/2015–present


Published: 27/03/2015


Published: 05/03/2013


Published: 01/12/2009


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