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

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Current effective version

Adopted 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

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2015–present


Published: 27/03/2015


Published: 05/03/2013


Published: 01/12/2009


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