Systemic lupus erythmatosus
Conditions
Interventions
bortezomib(1.3mg/m2) 2times/week total 8times.
saline
Sponsors
Tohoku university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age of 20y/o to 65 y/o 2) ALE diagnosed with ACR criteria 3) Treated with Predonisolone (more than 10mg/day and 6 months) 4) Treated with Immunosuppressant(more than 3 months) 5) SELENA-SLEDAI (6-31) 6) positive anti-dsDNA antiboy 7) Written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Previous bortezomib administration 2) Incresed steroid within 14 days. 3) History of malignacy. 4) Patients with peripheral neuropathy. 5) Patients with CNS lupus. 6) Patients with sevear renal disease. 7) History of hypersensitivity to mannitol or bolic acid. 8) Patients with interstitial pneumonia or pulmonary fibrosis. 9) Patients with sevear heart disease. 10) Patients with positive HBs Ag or HIV Ab or HCV Ab. 11) patients with hyperkalemia. 12) Patients with psychiatric disease. 13) Patients with sevear liver dysfunaction 14) Patients with uncontrolled diabetes mellitus. 15) Patients with uncontrolled hypertension. 16) Current or previous within the last 30 days history of sevear infectious disease. 17) The pregnant and lactating female , female who has possibility of the pregnancy. 18) Patients who were judged inappropriate to entry this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of anti-dsDNA antibody | — |
Countries
Japan
Contacts
Public ContactTomonori Ishii
Tohoku university hospital Hematology and Rheumatology
Outcome results
None listed