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

NCT02811094 | Terminated

• 2 other identifiers: 2015-262015-A00981-48
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• Area under the curve of the blood transcriptomic score to predict SLE flares.

  3 months

Study Arms (1)

Adult patients with Systemic LupusErythematosus (SLE)

OTHER

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

Interventions

polymerase chain reaction (PCR) technique of blood transcriptome analysis OTHER

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

Adult patients with Systemic LupusErythematosus (SLE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy, lactation

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la conception Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 23, 2016
• Study Start: November 9, 2016
• Primary Completion: January 14, 2020
• Study Completion: December 12, 2020
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

FR (1)