Study of Leukocyte Populations in Patients With Chronic Inflammatory

Not yet recruiting

• Conditions: Systemic Autoimmune Disease; Chronic Inflammatory Rheumatism; Sjogren's Syndrome; Systemic Lupus Erythematosus; Spondyloarthritis; Rheumatoid Arthritis

• Registration Number: NCT04749875
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

Detailed Description

The primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. We will perform an exploratory descriptive study whom primary endpoint will be to assess by FACS the phenotype of the specific leukocyte subsets. In addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: IL7 pathway, IFN signature).

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-06
• Last Update Submitted: 2021-02-06
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11
• Study Start: 2021-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Age ≥18 years
• Patient who did not express his opposition
• Patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pSS, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria.
• Weight> 35 kg

Exclusion Criteria

• Corticosteroid treatment> 10 mg / day
• Pregnant patient
• Patients under legal protection
• Beneficiary of the state medical aid

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases	At the end of the study (5 years)	Proportion of different leukocytes subset

Secondary Outcome Measures

Name	Time	Method
Protein study (ELISA on serum) : IL7	At the end of the study (5 years)	levels of IL7 and other cytokines
Transcriptome study (RNA) : mRNA levels	At the end of the study (5 years)	assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)
Genomic study (DNA) : SNPs	At the end of the study (5 years)	Determination of the genotype of different SNPs involved in IL7/IFN pathways

Trial Locations

Locations (1)

CHU Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France