Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 12:49 PM
Study NCT ID:
NCT07227428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: