Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT07227428
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.
Study:
NCT07227428
Study Brief:
Protocol Section:
NCT07227428