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Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

NCT ID: NCT07227428

Last Updated: 2025-11-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Keywords

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steroid taper adrenal insufficiency disease activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This study is a single-blind study without placebo control. Investigators who access the DAS28 will be blinded to the treatment

Study Groups

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5mg tablet taper

Prednisolone will be tapered using 5mg tablet formulation

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

PD will be tapered using a 5mg tab formulation

1mg tablet taper

Prednisolone will be tapered using 1 mg tablet formulation

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

PD will be tapered using a 1 mg tab formulation

Continue

Prednisolone will be continued

Group Type PLACEBO_COMPARATOR

Prednisolone

Intervention Type DRUG

PD will be continued

Interventions

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Prednisolone

PD will be tapered using a 5mg tab formulation

Intervention Type DRUG

Prednisolone

PD will be tapered using a 1 mg tab formulation

Intervention Type DRUG

Prednisolone

PD will be continued

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Pregnant or breastfeeding
* RA functional class IV, requiring confinement to bed or wheelchair
* History of primary or secondary adrenal insufficiency
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun Bong Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jin Kyu Park, MD, PhD

Role: CONTACT

Phone: 82-2-2072-4765

Email: [email protected]

Other Identifiers

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2502-080-1613

Identifier Type: -

Identifier Source: org_study_id