LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse (LUMIER²)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02811094|
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus (SLE)||Other: polymerase chain reaction (PCR) technique of blood transcriptome analysis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse|
|Actual Study Start Date :||November 9, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2021|
Adult patients with Systemic LupusErythematosus (SLE)
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.
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
- Area under the curve of the blood transcriptomic score to predict SLE flares. [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811094
|Contact: Noémie JOURDE-CHICHE||04 91 38 30 firstname.lastname@example.org|
|Hôpital de la conception Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Noémie JOURDE-CHICHE 04 91 38 30 42 email@example.com|
|Study Director:||Urielle DESALBRES||Assistance Publique Hôpitaux de Marseille|