Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus, SLE
• Interventions: Behavioral: Glucocorticoid maintenance group; Behavioral: Glucocorticoid withdrawal group

• Registration Number: NCT06234852
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief 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.

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 Timeline

• Study Start: 2023-01-24
• Primary Completion: 2023-12-26
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Status Verified: 2024-04
• Study Completion: 2024-04-17
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoid maintenance group	Glucocorticoid maintenance group	Maintenance of 5-mg of prednisolone daily over 24 weeks
Glucocorticoid withdrawal group	Glucocorticoid withdrawal group	Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

Primary Outcome Measures

Name	Time	Method
Any flare according any of 3 definitions	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.

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life	24 weeks	Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference)
Any increase in clinical SLEDAI-2K	24 weeks	Percentage of participants with any increase in clinical SLEDAI-2K
Any changes in immunology	24 weeks	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
Any increase in damage accrual	24 weeks	Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score.

Trial Locations

Locations (1)

Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine; 🇹🇭 Bangkok, Thailand