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

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ClinicalTrials.gov Identifier: NCT02811094
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus (SLE) Other: polymerase chain reaction (PCR) technique of blood transcriptome analysis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve of the blood transcriptomic score to predict SLE flares. [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Noémie JOURDE-CHICHE 04 91 38 30 42 noemie.jourde@ap-hm.fr

Locations
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France
Hôpital de la conception Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Noémie JOURDE-CHICHE    04 91 38 30 42    noemie.jourde@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02811094     History of Changes
Other Study ID Numbers: 2015-26
2015-A00981-48 ( Registry Identifier: ANSM )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases