LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse (LUMIER²)
Primary Purpose
Systemic Lupus Erythematosus (SLE)
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polymerase chain reaction (PCR) technique of blood transcriptome analysis
Sponsored by
About this trial
This is an interventional other trial for Systemic Lupus Erythematosus (SLE)
Eligibility 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
Sites / Locations
- Hôpital de la conception Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adult patients with Systemic LupusErythematosus (SLE)
Arm Description
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.
Outcomes
Primary Outcome Measures
Area under the curve of the blood transcriptomic score to predict SLE flares.
Secondary Outcome Measures
Full Information
NCT ID
NCT02811094
First Posted
June 16, 2016
Last Updated
July 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02811094
Brief Title
LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse
Acronym
LUMIER²
Official Title
LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID situation
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
December 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult patients with Systemic LupusErythematosus (SLE)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
polymerase chain reaction (PCR) technique of blood transcriptome analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the curve of the blood transcriptomic score to predict SLE flares.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital de la conception Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse
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