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

Phase 4

Recruiting

• Conditions: systemic lupus erythematosus; SLE; D008180

• Registration Number: JPRN-jRCT1031180196
• Lead Sponsor: Tamura Naoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse free survival rate at week 54.

Secondary Outcome Measures

Name	Time	Method
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)