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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

Exploratory Study of the Safety and SLE Flare Rate of Prednisolone Tapering in Patients with remitted SLE

Fujio Keishi

The University of Tokyo Hospital

7-3-1 Hongo. Bunkyo-ku,Tokyo

FUJIOK-INT@h.u-tokyo.ac.jp

Kouno Masanori

The University of Tokyo Hospital

7-3-1 Hongo. Bunkyo-ku,Tokyo

+81-338155411

mkouno-tky@g.ecc.u-tokyo.ac.jp

Recruiting

Mar. 24, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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.

Both

Systemic Lupus Erythematosus (SLE)

Prednisolone will be administered for 52 weeks while tapering using criteria for adrenal function recovery (morning cortisol level) in SLE patients in clinical remission.

SLE

Prednisolone tapering

SLE relapse rate up to Week 52 from the start of study treatment.

(1) Time to first SLE relapse.
(2) Proportion of SLE relapse by severity.
(3) Trends in anti-dsDNA antibody titers and complement (C3, 4) levels from the start of study treatment to 52 weeks.
(4) Amount of PSL tapering and final achieved dose by the end of study treatment.
(5) Incidence rate of glucocorticoid-related adverse events.
(6) Proportion of subjects who developed adrenal insufficiency.

+81-3-5841-3600

Mar. 17, 2026

No

none