Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

March 4, 2020

Primary Completion Date

May 3, 2022

Study Completion Date

May 3, 2022

Conditions
Systemic Lupus Erythematous (SLE)
Interventions
DRUG

Solu-Medrol 1mg/kg

Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an anti-inflammatory glucocorticoid that occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol, but is insoluble in chloroform and is very slightly soluble in acetone. The study agent solution will be administered as an IV infusion over 30 minutes, for a total single dose of 1 mg/kg of methylprednisolone.

DRUG

Solu-Medrol 250 mg

Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an anti-inflammatory glucocorticoid that occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol, but is insoluble in chloroform and is very slightly soluble in acetone. The study agent solution will be administered as an IV infusion over 30 minutes, for a total single dose of 250 mg of methylprednisolone.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

NCT04233164 - Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter