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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031250833

Enrollment

Registered

2026-03-24

Start date

2026-03-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE) SLE

Interventions

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

Prednisolone tapering

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Individuals diagnosed with SLE who fulfill any of the following classification criteria: - The 1997 revised ACR classification criteria - The 2012 SLICC classification criteria - The 2019 EULAR/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) = 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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
SLE relapse rate up to Week 52 from the start of study treatment.	—

Secondary

Measure	Time frame
(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.	—

Contacts

Public ContactMasanori Kouno

The University of Tokyo Hospital

mkouno-tky@g.ecc.u-tokyo.ac.jp+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026