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