NCT02811094

LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity

Detailed description

Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity. We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion. LUMIER² is a prospective multicentric observational study conducted in the departments of Clinical Nephrology, Internal Medicine and Rheumatology in the South of France. Adult patients with SLE, clinically quiescent and with no change in treatment in the past 3 months, will be included and followed-up for 12 months. Blood samples will be drawn every 3 months during 12 months in the absence of flare. Patients presenting a flare will be sampled at the time of the flare and 1 month later. The inclusion of 300 patients is expected, with a test cohort (150 patients) and a validation cohort (150 patients).

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
OTHER	polymerase chain reaction (PCR) technique of blood transcriptome analysis	this study (LUMIER2 study) is to test the hypothesis that a test score or prognostic transcriptomic allows to discriminate clinically quiescent or patients who will not present a push of Systemic Lupus Erythematosus

Timeline

• Start date: 2016-11-09
• Primary completion: 2020-01-14
• Completion: 2020-12-12
• First posted: 2016-06-23
• Last updated: 2023-07-21

Locations

1 site across 1 country: France