Estimate of the Activity and the Forecast of the Lupus Disease of the Adult by a Transcriptomic Score (STUDY LU-PUCE)

Not Applicable

Completed

• Conditions: Lupus Disease
• Interventions: Biological: blood sample

• Registration Number: NCT00920114
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2011-05
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Lupus disease diagnosed for lupus disease arm
• Signed assent

Exclusion Criteria

• non-compliance
• pregnancy
• persons without social coverage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy witnesses	blood sample	-
Lupus disease	blood sample	-
Healthy witnesses with an other auto-immune disease	blood sample	-

Primary Outcome Measures

Name	Time	Method
Identify the genes expressed during the disease to allow the calculation of a transcriptomic score and study the correlation of this transcriptionnal score with the SLEDAI score	2 years

Secondary Outcome Measures

Name	Time	Method
Identify genes correlated in various histological classes of lupus renal disease and types of pushes of the disease; to allow the calculation of a transcriptomic score and its correlation with the BILAG score	2 years

Trial Locations

Locations (1)

Assistance Publique-Hopitaux de Marseille; 🇫🇷 Marseille, France