Study of Leukocyte Populations in Patients With Chronic Inflammatory

Rheumatoid Arthritis Clinical Trial

— LIMA  

Official title:

Study of Leukocyte Populations in Patients With Chronic Inflammatory

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04749875
• Other study ID #: APHP210093
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Xavier MARIETTE
• Phone: 00 33 1 45 21 37 58
• Email: xavier.mariette[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Inflammatory Rheumatism
• Collagen Diseases
• Lupus Erythematosus, Systemic
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Spondylarthritis
• Spondyloarthritis
• Systemic Autoimmune Disease
• Systemic Lupus Erythematosus

Intervention

Other:
• blood sample
sampling of blood for research during routine care

Locations

Country	Name	City	State
France	CHU Bicêtre	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases	Proportion of different leukocytes subset	At the end of the study (5 years)
Secondary	Protein study (ELISA on serum) : IL7	levels of IL7 and other cytokines	At the end of the study (5 years)
Secondary	Transcriptome study (RNA) : mRNA levels	assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)	At the end of the study (5 years)
Secondary	Genomic study (DNA) : SNPs	Determination of the genotype of different SNPs involved in IL7/IFN pathways	At the end of the study (5 years)