Glucocorticoid-tapering aimed maintenance therapy in patients with systemic lupus erythematosus
- Conditions
- systemic lupus erythematosus
- Registration Number
- JPRN-UMIN000031259
- Lead Sponsor
- First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Not provided
a) Patients who contraindicated by package insert of BLM. b) Receipt of B cell depleted therapy (biologic agent) within 1 year. c) Receipt of cyclophosphamide (Endoxan) within 6 months. d) Receipt of high dose GC (prednisolone equivalent 1mg/kg) within 6 months. e) Receipt of plasma exchange within 6 months. f) Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases). g) Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve glucocorticoid free [Time Frame: Week 52]
- Secondary Outcome Measures
Name Time Method Secondary endpoints 1) Score of SELENA-SLEDAI [Time Frame: Week 24 and 52] 2) Mean changes from baseline in Physician's Global Assessment (PGA) using visual analogue scale (VAS) [Time Frame: Week 24 and 52] 3) Mean dose of glucocorticoids (Last Observation Carried Forward) 4) Annualized flare rate with flare defined as SELENA - SLEDAI score > 4 points [Time Frame: Week 52] Exploratory endpoints 1) The mean duration, subjects achieve 50% dose reduction of glucocorticoid [Time Frame: Week 52] 2) The immunophenotype of peripheral blood by flow cytometric analysis [Time Frame: Week 52] 3) The differences of immunophenotype, biomarkers, and autoantibodies between the patients who could achieve glucocorticoid free and the patients who could not achieve glucocorticoid free [Time Frame: Week 52]