NCT04360772

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

Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	mHLA-DR	* Before treatment/ At inclusion/Day 0 : Collection of gender, date of birth, comorbidities, pathology implicating treatment by corticosteroids and other treatment administered at the time of inclusion. * At Day 0, Month 1, Month 3, Month 6 : Blood sampling (3mL) to proceed to mHLA-DR measurement. At those time-points, results from lymphocytes immunophenotyping, C-reactive protein and numeration will be collected. * At Month 24 : Collection from medical report of * any infectious events that would have occured during the follow-up * course of the disease with corticosteroids * survival or death at 24 months of follow-up.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-04-24
• Last updated: 2024-02-09