systemic lupus erythematosus
Conditions
Sponsors
Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital; 2. Patients of SLE, to be aged 18 years to 65 years old; 3. All patients fulfilled the 2012 SLICC of SLE classification criteria, SLEDAI >=8;or BILAG score A/B; 4. Lupus nephritis with 24h urine protein>=1g; 5. Refractory disease as determined by failure of the following regimens: 5.1 Trial of corticosteroids (oral prednisone more than 7.5 mg/day); 5.2 Trial of cyclophosphamide 0.4~0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g/day, for three months.
Exclusion criteria
Exclusion criteria: 1. Patients with uncorrected disease, such as advanced cancer or other terminal illness, the prospective survival period less than 28 days; 2. Patients in the foreseeable dying state; 3. Have the bone marrow, lungs, liver, pancreas, or small bowel transplantation history; 4. Known or potential of portal hypertension, chronic icteric, chronic liver cirrhosis and ascites; 5.Have severe heart and lung failure, or irreversible damage or failure of other major organs; 6. Uncontrolled infection; 7. Patient participating or having participated in a clinical trial with another investigational drug Within 30 days before the start of this clinical trial; 8. Patient is pregnant or nursing; 9. History of patient is allergic to biological products; 10. HIV infected;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLEDAI;BILAG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lupus serology;Renal function;Liver function;Routine blood test;Electromyography;Imaging; | — |
Countries
China
Contacts
Public ContactXiang Xu
Outcome results
None listed