NCT07227428Not yet recruitingPhase 4
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
This multicenter, randomized, controlled, single-blind prospective study aims to establish an evidence-based protocol for discontinuing long-term low-dose glucocorticoids in patients with rheumatoid arthritis (RA). The study will compare two tapering strategies (1) a split-dose tapering method, in which the 5 mg tablet is divided into halves and gradually reduced, and (2) a sequential 1 mg-by-1 mg tapering method. 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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 7 Nov 2025
- Start date
- Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07227428
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 206
- From Dec 2025 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major surgery within 8 weeks prior to screening
- Increase in the dose of antirheumatic drugs within 4 weeks prior to screening due to worsening arthritis
Other illness
- History of primary or secondary adrenal insufficiency
Other
- Pregnant or breastfeeding
- RA functional class IV, requiring confinement to bed or wheelchair
Who the study is looking for
- Males or females ≥19 years of age at time of consent
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.