NCT06234852

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

The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus, SLE

Interventions

Type	Name	Description
BEHAVIORAL	Glucocorticoid withdrawal group	Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
BEHAVIORAL	Glucocorticoid maintenance group	Daily 5-mg prednisolone over 24 weeks

Timeline

• Start date: 2023-01-24
• Primary completion: 2023-12-26
• Completion: 2024-04-17
• First posted: 2024-01-31
• Last updated: 2024-04-19

Locations

1 site across 1 country: Thailand