Exploratory Study of the Safety and SLE Flare Rate of Prednisolone Tapering and Discontinuation Based on Adrenal Function Recovery Criteria in Patients with Systemic Lupus Erythematosus in Clinical Remission

Not provided0 sites28 target enrollmentStarted: TBD

Overview

No summary available.

•(1) Diagnosed with SLE based on the 1997 revised ACR classification criteria.
•(2) Maintained clinical remission (meeting all of the following criteria) for 24 weeks or more prior to obtaining consent.
•Clinical SLEDAI score = 0
•Physician Global Assessment (PGA) < 0.5 (0-3)
•(3) Continued prednisolone 5 mg/day for SLE for 4 weeks or more prior to obtaining consent.
•(4) No dosage change in immunosuppressants (including biologics) and hydroxychloroquine for 24 weeks or more prior to obtaining consent.
•(5) Age: >= 18 years old at the time of obtaining consent.
•(6) Gender: Any.
•(7) Obtained written informed consent based on the subject's free will after receiving a full explanation and fully understanding the participation in this study.
•(8) Able to visit the outpatient clinic according to the study schedule.

•(1) Patients with severe infections.
•(2) Patients with comorbid malignancies.
•(3) Patients with clinical symptoms suspected of adrenal insufficiency.
•(4) Patients who are pregnant or possibly pregnant.
•(5) Patients who are breastfeeding.
•(6) Patients using desmopressin acetate hydrate (Minirin Melt).
•(7) Others judged inappropriate for participation in this study by the principal investigator or sub-investigator.

Sponsor

Not provided