Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.
NCT ID: NCT06234852
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-01-24
2024-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glucocorticoid maintenance group
Maintenance of 5-mg of prednisolone daily over 24 weeks
Glucocorticoid maintenance group
Daily 5-mg prednisolone over 24 weeks
Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
Interventions
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Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
Glucocorticoid maintenance group
Daily 5-mg prednisolone over 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Phramongkutklao College of Medicine and Hospital
OTHER
Responsible Party
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Principal Investigators
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Rattapol Pakchotanon, M.D.
Role: STUDY_DIRECTOR
Phramongkutklao College of Medicine and Hospital
Locations
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Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, , Thailand
Countries
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References
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Niyompanichakarn S, Chaiamnuay S, Narongroeknawin P, Asavatanabodee P, Leosuthamas P, Pakchotanon R. The Effect of Gradual Withdrawal Versus Maintenance of Low-Dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Double-Blind Randomised Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70083. doi: 10.1002/msc.70083.
Other Identifiers
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LUCRA001
Identifier Type: -
Identifier Source: org_study_id
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