systemic lupus erythematosus SLE
Conditions
Interventions
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, continue
D046650
Sponsors
Tamura Naoto
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survival rate at week 54. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactYoshiyuki Abe
Juntendo University Hospital
Outcome results
None listed