lupus myelopathy
Conditions
Interventions
A:Rituximab (MabThera,500mg, intravenously weekly or biweekly for 2-3 times)
Sponsors
Shanghai JiaoTong University School of Medicine Affiliated Renji Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meet both the American College of Rheumatology (ACR) criteria of SLE in 1997 and the definition of myelopathy, that is, acute or subacute onset of a spinal cord lesion with associated motor or sensory deficits, and sphincter dysfunction; 2. Lower extremity muscle strength <=grade 3; 3. Be refractory to pulse methylprednisolone treatment and/or in combination with immunosuppressive agent; 4. Written informed consent was obtained from each patient or their family members.
Exclusion criteria
Exclusion criteria: 2. Allergic to Rituximab or mouse protein; 3. Severe infection; 4. Abnormal liver function (alanine or aspartate aminotransferase 2 times above the upper limit of normal); renal dysfunction (serum creatinine levels above the upper limit of the various research units); 5. WBC<1.5*10^9/L or PLT<75*10^9/L; 6. Pregnant or lactating women; 7. Hepatitis B virus carrier; chronic hepatitis B infection; active tuberculosis infection; 8. Patients with heart disease or pulmonary insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BILAG index score;WISCI;ASIA impairment scale; | — |
Countries
China
Contacts
Public ContactShuang Ye
Outcome results
None listed