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

Not Applicable

Terminated

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Other: polymerase chain reaction (PCR) technique of blood transcriptome analysis

• Registration Number: NCT02811094
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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).

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Study Start: 2016-11-09
• Primary Completion: 2020-01-14
• Study Completion: 2020-12-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Age ≥18 years
• SLE defined by ACR criteria
• Clinically quiescent disease (SLEDAI =< 4 without clinical flare) and absence of treatment increase in the past 3 months
• Written informed consent

Exclusion Criteria

• Pregnancy, lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult patients with Systemic LupusErythematosus (SLE)	polymerase chain reaction (PCR) technique of blood transcriptome analysis	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.

Primary Outcome Measures

Name	Time	Method
Area under the curve of the blood transcriptomic score to predict SLE flares.	3 months

Trial Locations

Locations (1)

Hôpital de la conception Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France