Optimal tapering regimens of glucocorticoid for severe SLE: multi-center randomized open label trial

JRCT ID: jRCT1031180196

Registered date:06/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: systemic lupus erythematosus
• Date of first enrollment: 15/04/2019
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Conventional therapy group: After initial dose is continued for 2 to 4 weeks, tapering GC every 2 weeks according to the following dose
60 mg -50 mg - 45 mg - 40 mg - (tapering every 2 weeks, continued hospitalization)
37.5 mg - 35 mg - 32.5 mg - 30 mg - (tapering every 4 weeks)
Rapid Tapering Group: After continuing the initial dose for 2 to 4 weeks, tapering GC every week according to the following dose
60 mg - 50 mg - 45 mg - 40 mg - 35 mg - 30 mg - (tapering every week, continued hospitalization)
After tapering less than 30 mg, GC dose is decided by the attending physician.

Outcome(s)

• Primary Outcome: Relapse free survival rate at week 54.
• Secondary Outcome: Total dose and minimum maintenance dose of corticosteroid per unit period, ratio of infection requiring hospitalization, relapse free survival rate at 104 weeks and 156 weeks and achievement rate of Lupus low disease activity state (LLDAS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Men and women aged over 20 years, able and willing to give written informed consent, fulfilled 1997 ACR classification criteria for SLE or SLICC criteria for SLE classification, have received 0.5 mg/kg/day or more and over 45mg/day of oral prednisolone or equivalent doses of corticosteroids with or without any immunosuppressant.
• Exclude criteria: Unable to give informed consent, have uncontrollable complications, being pregnant or a nursing woman, Men and women with plan of pregnancy within 52 weeks

Related Information

• Primary Sponsor: Tamura Naoto