systemic lupus erythematosus
Conditions
Interventions
None listed
Sponsors
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Diagnosed as SLE by American College of Rheumatology (ACR) classification criteria. b) Patients who have low disease activity (SELENA-SLEDAI < 4 points) c) Receipt of low dose GC (no more than prednisolone equivalent 10 mg) over 30 days d) Receipt of HCQ and/or other immunosuppressive drug such as Azathioprine and MMF over 30 days.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve glucocorticoid free [Time Frame: Week 52] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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] | — |
Countries
Japan
Contacts
Public ContactSatoshi Kubo
School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine
Outcome results
None listed