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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Systemic Lupus Erythematosus (SLE)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
June 16, 2016
Last Updated
July 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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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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