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

Phramongkutklao College of Medicine and Hospital

Status: Completed

Conditions: Systemic Lupus Erythematosus, SLE

Treatments: Behavioral: Glucocorticoid withdrawal group; Behavioral: Glucocorticoid maintenance group

Study type: Interventional

Funder types: Other

Identifiers

NCT06234852

LUCRA001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Glucocorticoid maintenance group

Active Comparator group

Description:

Maintenance of 5-mg of prednisolone daily over 24 weeks

Treatment:

Behavioral: Glucocorticoid maintenance group

Glucocorticoid withdrawal group

Placebo Comparator group

Description:

Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

Treatment:

Behavioral: Glucocorticoid withdrawal group