Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR). (HLA-DR)

Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR

Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.

Study Overview

• Status: Withdrawn
• Conditions: Immunosuppression
• Intervention / Treatment: Diagnostic test: mHLA-DR

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: ARNAUD HOT, MD; Phone Number: +33 04.72.11.75.65; Email: arnaud.hot@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patient Diagnosed With Any Pathology Indicating a Treatment by Corticotherapy

Description

Inclusion Criteria:

• Patient aged of 18 years old or more, male or female.
• Patient diagnosed with any pathology indicating a treatment by corticotherapy at 1mg/kg/day.
• Patient who didn't express any opposition to be enrolled in the study after reading the dedicated information letter.
• Patient affiliated to social heath care regimen

Exclusion Criteria:

• Treatment by corticosteroids in the previous 6 months.

  • Immunsuppressive treatment (except for corticosteroids) in the previous 2 years.
  • Patient under judicial protection, guardianship or curators

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses	mHLA-DR expression level will be compared between : Before treatment and at 1 month of treatment; Before treatment and at 3 months of treatment; Before treatment and at 6 months of treatment; 1 month and 3 months of treatment; 1 month and 6 months of treatment	Month 1, 3 and 6

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: ARNAUD HOT, MD, Service de Médecine Interne

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: any pathology; corticosteroids therapy
• Other Study ID Numbers: 69HCL19_1029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No