Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
NCT ID: NCT07227428
Last Updated: 2025-11-25
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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NOT_YET_RECRUITING
PHASE4
206 participants
INTERVENTIONAL
2025-12-01
2027-12-31
Brief Summary
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A total of 206 patients (including 50 from Seoul National University Hospital) will be enrolled and followed for six months. Participants will be randomly assigned to one of the two tapering arms, and an exploratory group will include patients who continue low-dose prednisolone without tapering.
The primary efficacy endpoint is the change in RA disease activity, measured by DAS28-CRP, to demonstrate non-inferiority between the two tapering strategies. Secondary endpoints include the success rate of glucocorticoid discontinuation and changes in disease activity over time.
This trial seeks to define a standardized, practical glucocorticoid tapering protocol tailored to Korean RA patients. The findings are expected to support safer steroid withdrawal, reduce treatment-related adverse events, and guide clinical decision-making in long-term management of rheumatoid arthritis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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5mg tablet taper
Prednisolone will be tapered using 5mg tablet formulation
Prednisolone
PD will be tapered using a 5mg tab formulation
1mg tablet taper
Prednisolone will be tapered using 1 mg tablet formulation
Prednisolone
PD will be tapered using a 1 mg tab formulation
Continue
Prednisolone will be continued
Prednisolone
PD will be continued
Interventions
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Prednisolone
PD will be tapered using a 5mg tab formulation
Prednisolone
PD will be tapered using a 1 mg tab formulation
Prednisolone
PD will be continued
Eligibility Criteria
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Inclusion Criteria
* Body weight \< 90kg
* Have a diagnosis of RA per the 2010 ACR/EULAR criteria for at least 6 months
* Disease activity of rheumatoid arthritis has been stable for at least 4 weeks prior to randomization (DAS28-CRP ≤ 3.2)
* The patient has been taking a stable dose of prednisolone equivalent ≤ 5 mg/day for at least 12 weeks prior to randomization
* The dose of corticosteroids has not changed during the 4 weeks prior to randomization
Exclusion Criteria
* Increase in the dose of antirheumatic drugs within 4 weeks prior to screening due to worsening arthritis
* Pregnant or breastfeeding
* RA functional class IV, requiring confinement to bed or wheelchair
* History of primary or secondary adrenal insufficiency
19 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Gachon University Gil Medical Center
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Eun Bong Lee
Professor
Central Contacts
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Other Identifiers
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2502-080-1613
Identifier Type: -
Identifier Source: org_study_id
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