NOCOMPOUNDLUP0001
Research type
Research Study
Full title
Longitudinal study of skin and systemic biomarkers in subjects with active cutaneous lupus erythematosus and in healthy volunteers
IRAS ID
141261
Contact name
David D'Cruz
Contact email
david.d'cruz@kcl.ac.uk
Sponsor organisation
Janssen Research and Development
Clinicaltrials.gov Identifier
Research summary
Approximately 5 million patients suffer from lupus worldwide. Lupus Erythematosus (LE) is a complex genetically based autoimmune disease (the body’s immune system ‘attacks’ healthy tissue); little is understood regarding causes. In some patients symptoms of LE are expressed only in the skin throughout the entire course of the disease. In others the disease impacts on internal organs such as the joints, the kidneys and central nervous system. It is a poorly understood, chronic and debilitating disease which damages internal organs and requires long term treatment, currently with toxic medicines. Clinical trials for lupus have been challenging because not all lupus patients are alike and the disease scoring instruments are difficult to use in clinical trials. The results of this are that despite drug development there is a lack of safe, effective therapies for lupus. The consequences of the way the disease presents itself makes diagnosis, classification and treating difficult. This study will be conducted to increase the understanding of the inflammatory pathways in lupus, how these pathways change over time focusing on the blood and skin and the impact that changes in medication has on these. We are also interested in how these inflammatory pathways differ between patients from different racial and ethnic backgrounds. The study aims to increase our understanding of the pathology and molecular mechanisms of lupus. In order for us to do this we are asking study subjects with lupus to provide us with blood, urine and small skin biopsy samples for further analysis. Up to 60 subjects with lupus will be enrolled into the study. As this is a non-intervention study no medications are being tested. Subjects will continue in the study for 92-95 days or until they withdraw their consent.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0018
Date of REC Opinion
30 Jan 2014
REC opinion
Further Information Favourable Opinion