Systemic Lupus Erythematosus, SLENCT06234852
Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.
A study testing Glucocorticoid withdrawal group and Glucocorticoid maintenance group in people with Systemic Lupus Erythematosus, SLE, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, SLE
- What is being tested?
- Glucocorticoid withdrawal group and Glucocorticoid maintenance group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 24 Jan 2023to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged; 20 years
- Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
- Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
- Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.
Who cannot join
- Pregnant or pregnancy planning
- Unable to follow the schedules
- Overlap with other autoimmune disease, except secondary SjS and APS
- Co-morbid with any other condition which required prednisolone treatment
- Documented adrenal insufficiency
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, 10400
About this study
Official title: The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.
This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
Read the detailed description
Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
- Conditions
- Systemic Lupus Erythematosus, SLE
- Being tested
- Glucocorticoid withdrawal group, Glucocorticoid maintenance group
- Keywords
- Systemic Lupus Erythematosus, Glucocorticosteroid, Flare
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid withdrawal groupBehavioural
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
Glucocorticoid maintenance groupBehavioural
Daily 5-mg prednisolone over 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid maintenance group | Active comparator | Maintenance of 5-mg of prednisolone daily over 24 weeks Receives: Behavioral: Glucocorticoid maintenance group |
| Glucocorticoid withdrawal group | Placebo comparator | Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks Receives: Behavioral: Glucocorticoid withdrawal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any flare according any of 3 definitions
Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants.
Measured: 24 weeks
Secondary outcomes (4)
Any increase in clinical SLEDAI-2K
Percentage of participants with any increase in clinical SLEDAI-2K
Measured: 24 weeks
Any changes in immunology
Percentage of participants with the decrease of C3 or C4 by 50% and/or the increase of anti-dsDNA by 25% as compared with baseline
Measured: 24 weeks
Any increase in damage accrual
Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score.
Measured: 24 weeks
Changes in quality of life
Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start24 Jan 2023
- Primary completion26 Dec 2023
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus, SLEStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rattapol Pakchotanon, M.D., Study director, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234852
- Sponsor's protocol ID
- LUCRA001
- Status last verified
- Apr 2024
- First submitted
- 14 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol is to be shared with others. Full data would become available by mid 2025.
Publications
Niyompanichakarn S, Chaiamnuay S, Narongroeknawin P, Asavatanabodee P, Leosuthamas P, Pakchotanon R. The Effect of Gradual Withdrawal Versus Maintenance of Low-Dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Double-Blind Randomised Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70083. doi: 10.1002/msc.70083.
PubMed 40148251
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT06234852
- Acronym / sponsor ID
- LUCRA001
- Conditions
- Systemic Lupus Erythematosus, SLE
- Keywords
- Systemic Lupus Erythematosus, Glucocorticosteroid, Flare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 31 Jan 2024 (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 study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
Detailed description
Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid maintenance group | Active comparator | Behavioral: Glucocorticoid maintenance groupMaintenance of 5-mg of prednisolone daily over 24 weeks |
| Glucocorticoid withdrawal group | Placebo comparator | Behavioral: Glucocorticoid withdrawal groupGradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged; 20 years
- Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
- Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
- Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.
Key exclusion criteria (5 listed)
- Pregnant or pregnancy planning
- Unable to follow the schedules
- Overlap with other autoimmune disease, except secondary SjS and APS
- Co-morbid with any other condition which required prednisolone treatment
- Documented 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 |
|---|---|---|
| Glucocorticoid withdrawal groupGradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks | Behavioural | Glucocorticoid withdrawal group |
| Glucocorticoid maintenance groupDaily 5-mg prednisolone over 24 weeks | Behavioural | Glucocorticoid maintenance group |
Primary outcome
Any flare according any of 3 definitions
Time frame: 24 weeks
Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants.
4 secondary outcomes
Any increase in clinical SLEDAI-2K
Time frame: 24 weeks
Any changes in immunology
Time frame: 24 weeks
Any increase in damage accrual
Time frame: 24 weeks
Changes in quality of life
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 40148251Niyompanichakarn S, Chaiamnuay S, Narongroeknawin P, Asavatanabodee P, Leosuthamas P, Pakchotanon R. The Effect of Gradual Withdrawal Versus Maintenance of Low-Dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Double-Blind Randomised Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70083. doi: 10.1002/msc.70083.
- Individual participant dataSharing planned: Yes. Study Protocol is to be shared with others. Full data would become available by mid 2025.
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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. This study is not recruiting at the moment.
Rattapol Pakchotanon, M.D. study director
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucocorticoid withdrawal group and Glucocorticoid maintenance group in people with Systemic Lupus Erythematosus, SLE, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 4 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: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any flare according any of 3 definitions (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06234852, which also lists 1 linked publication.
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 19 Apr 2024.