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Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

NCT07227428 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Prednisolone

PD will be tapered using a 5mg tab formulation

DRUG

Prednisolone

PD will be tapered using a 1 mg tab formulation

DRUG

Prednisolone

PD will be continued

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • SMG-SNU Boramae Medical Center

    collaborator OTHER

  • Gachon University Gil Medical Center

    collaborator OTHER

  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227428 on ClinicalTrials.gov