Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus
Status:
Recruiting
Trial end date:
2024-02-29
Target enrollment:
Participant gender:
Summary
Background:
The immune system is the body s defense against bacteria and other harmful invaders. In
people with systemic lupus erythematosus (SLE), the immune system becomes overactive and
attacks healthy cells by mistake. Many people use glucocorticoids (GCs) to treat their SLE.
GCs can calm down an overactive immune system by changing how the body reads genes. But GCs
have side effects that can increase over time. Researchers want to learn more about how GCs
work. This may help to develop new and better drugs for treating SLE without the side effects
GCs have.
Objective:
To better understand how GCs affect the immune system in people with SLE.
Eligibility:
People age 18-80 with SLE.
Design:
Participants will be screened with a physical exam. They will have a health and medical
history. They will have blood and urine tests. They will have an electrocardiogram to measure
heart activity. For this, sticky pads are put on their chest, arms, and legs.
Participants will have a methylprednisolone infusion for about 30 minutes. It will be given
through a needle in a vein.
Blood will be collected immediately before, 2 hours after, and 4 hours after the start of the
infusion. Blood pressure and heart activity will be monitored. Participants will repeat some
of the screening tests.
Participants will be contacted twice in the week after the infusion visit. They will discuss
any health problems they are having.
Phase:
Early Phase 1
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)