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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02811094

Acronym

LUMIER²

Enrollment

210

Registered

2016-06-23

Start date

2016-11-09

Completion date

2020-12-12

Last updated

2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE)

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).

Interventions

OTHERpolymerase 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026