Pemphigus
Conditions
Interventions
Individualized rituximab group:Individualized rituximab regimen (the initial dose is 100mg, and 1 month later for those peripheral blood B cells are not depleted will be given 500mg,and 1 month later
Conventional dosage of glucocorticoid group:Conventional dosage of glucocorticoid ?for patients with severe pemphigus (PDAI>45): 1.5mg/kg/d,for patients with moderate pemphigus (15=PDAI=45): 1mg/kg/d
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.age>=18 and <=80years 2.newly-treated pemphigus vulgaris (PV) or pemphigus foliaceus (PF) or those patients treated with glucocorticoid or immunosuppressant who have difficulty in tapering or unable to tolerate or undergo relapse 3. PV or PF patients who meet the following diagnostic criteria: a. Clinical manifestations: clinical features of PV or PF b. Histopathology:suprabasilar acantholysis or acantholysis in the granular layer c. Autoantibodies: Positive anti-Dsg1 and/or Dsg3 antibodies detected in serum by enzyme-linked immunosorbent assay (ELISA) 4.effective female contraceptive method for women in procreate age 5.consent obtained from patient
Exclusion criteria
Exclusion criteria: 1.patient treated with rituximab 2.pregnant woman or nursing mother 3.severe active infection 4.positive HIV serology 5.active hepatitis B/C infection 6.allergic to rat protein 7.serious cardiovascular diseases, such as unstable angina pectoris or ischemic heart disease, cardiac insufficiency, arrhythmia, etc. 8.karnovsky < 50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete remission(CR) at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve complete remission;Duration of complete remission;Control time;Rate of relapse;Changes of PDAI from baseline;Rate of adverse effects ;Changes of antibodies from baseline;Expense;Changes in the number of antigen-specific B cells and proportion of antigen specific B cells to peripheral blood B cells from baseline;Rate of CROT at 12 months;Rate of CRMT at 12 months; | — |
Countries
Beijing
Contacts
Public ContactMingyue Wang
Peking University First Hospital
Outcome results
None listed