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NCT04233164 · ClinicalTrials.gov registry record · Early Phase 1
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus
A Early Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 47
- Enrollment target
NCT04233164 is a Early Phase 1 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 47 participants.
The verdict
NCT04233164, a Early Phase 1 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 47 participants
- Enrollment target
Study 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.
Interventions
- DRUG Solu-Medrol 1mg/kg
- DRUG Solu-Medrol 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2022-05-03 |
| Phase | Early Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04233164
The ClinicalTrials.gov registry entry for NCT04233164 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Solu-Medrol 1mg/kg is the first listed.
NCT04233164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04233164 about?
NCT04233164 is a clinical study titled "Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus". 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 ...
What is the current status of trial NCT04233164?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 47 participants. The study started on 2020-03-04. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04233164?
The interventions under investigation include: Solu-Medrol 1mg/kg (DRUG), Solu-Medrol 250 mg (DRUG).
Who is sponsoring clinical trial NCT04233164?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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