Rheumatoid Arthritis (RA)Phase 4NCT07227428
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
A Phase 4 study testing Prednisolone in people with Rheumatoid Arthritis (RA), run by Seoul National University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.
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.
Read more
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)
- Being tested
- Prednisolone
- Keywords
- steroid taper, adrenal insufficiency, disease activity
- Medical subject headings
- Arthritis, Rheumatoid, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
PD will be tapered using a 5mg tab formulation
PrednisoloneDrug
PD will be tapered using a 1 mg tab formulation
PrednisoloneDrug
PD will be continued
| Study group | Role | What they receive |
|---|---|---|
| 5mg tablet taper | Experimental | Prednisolone will be tapered using 5mg tablet formulation Receives: Drug: Prednisolone |
| 1mg tablet taper | Active comparator | Prednisolone will be tapered using 1 mg tablet formulation Receives: Drug: Prednisolone |
| Continue | Placebo comparator | Prednisolone will be continued Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score 28-CRP
Disease activity: Remission <2.6; Low 2.6-3.2; Moderate >3.2-5.1 High >5.1
Measured: 6 months
Secondary outcomes (4)
Number of Participants with RA flare
Measured: 6 months
Number of adrenal insufficiency
Measured: 6 months
Frequency of rescue medication use (%)
Measured: 6 months
Rate of successful steroid discontinuation (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gachon University Gil Medical Center, Chung-Ang University Hospital
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227428
- Sponsor's protocol ID
- 2502-080-1613
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07227428
- Acronym / sponsor ID
- 2502-080-1613
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- steroid taper, adrenal insufficiency, disease activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gachon University Gil Medical Center, Chung-Ang University Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5mg tablet taper | Experimental | Drug: PrednisolonePrednisolone will be tapered using 5mg tablet formulation |
| 1mg tablet taper | Active comparator | Drug: PrednisolonePrednisolone will be tapered using 1 mg tablet formulation |
| Continue | Placebo comparator | Drug: PrednisolonePrednisolone will be continued |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisolonePD will be tapered using a 5mg tab formulation | Drug | 5mg tablet taper |
| PrednisolonePD will be tapered using a 1 mg tab formulation | Drug | 1mg tablet taper |
| PrednisolonePD will be continued | Drug | Continue |
Primary outcome
Disease Activity Score 28-CRP
Time frame: 6 months
Disease activity: Remission <2.6; Low 2.6-3.2; Moderate >3.2-5.1 High >5.1
4 secondary outcomes
Number of Participants with RA flare
Time frame: 6 months
Number of adrenal insufficiency
Time frame: 6 months
Frequency of rescue medication use (%)
Time frame: 6 months
Rate of successful steroid discontinuation (%)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Rheumatoid Arthritis (RA), run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Kyu Park, MD, PhD (82-2-2072-4765, jinkyunpark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score 28-CRP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.