Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.
Launched by PHRAMONGKUTKLAO COLLEGE OF MEDICINE AND HOSPITAL · Jan 30, 2024
Trial Information
Current as of July 15, 2025
Completed
Keywords
ClinConnect Summary
Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Aged; 20 years
- • Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
- • Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
- • Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.
- Exclusion Criteria:
- • Pregnant or pregnancy planning
- • Unable to follow the schedules
- • Overlap with other autoimmune disease, except secondary SjS and APS
- • Co-morbid with any other condition which required prednisolone treatment
- • Documented adrenal insufficiency
About Phramongkutklao College Of Medicine And Hospital
Phra Mongkutklao College of Medicine and Hospital is a prestigious medical institution in Thailand, dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on medical education and patient care, the institution fosters a collaborative environment for researchers, healthcare professionals, and students. The college is committed to conducting rigorous clinical trials that aim to enhance medical knowledge, improve treatment outcomes, and contribute to the overall health of the community. Its experienced team is dedicated to adhering to the highest ethical standards and regulatory guidelines, ensuring the integrity and reliability of its research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, , Thailand
Patients applied
Trial Officials
Rattapol Pakchotanon, M.D.
Study Director
Phramongkutklao College of Medicine and Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported