pemphigus
Conditions
Interventions
Infuse rituximab 1000mg/body twice biweekly
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient diagnosed as pemphigus and relapse disease taking corticosteroids more then PSL 10mg/day 2) PDAI>=1 3) Greater than or equal to 20 years of age and younger than or equal to 80 years of age. 4) Able to understand and sign the Informed Consent Document.
Exclusion criteria
Exclusion criteria: 1) Women who may possibly be pregnant or pregnant and men who plan to impregnate a woman 2) Allergy to humanized monoclonal antibody and/or murine monoclonal antibody, murine derived component 3) Active major medical illnesses 4) Active infections 5) Past history of infection within 8weeks 6) Past history of taking antibiotics (oral ; within 2weeks, infusion ; 8weeks) 7) Past history of bacteremia within 1 year 8) Past history of deep tissue infections and/or abscess 9) chronic and/or recurrent infections 10) Past history ofPatients who have or had malignancies 11) Past history of alcoholism and/or drug intoxication 12) Patients who have severe psychiatric disease 13) Past history of surgical operation within 4weeks 14) Past history of severe infection during taking immunosuppressive agent 15) vaccinated within 28weeks 16) Have laboratory parameters without Protocol-defined range 17) Infused Rituximab within 24weeks 18) Past history of Rituximab therapy more than 3times 19) taking other investigational drugs 20) ineffectiveness of past Rituximab therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(CTCAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy(remission, PDAI, antibody titer) | — |
Countries
Japan
Contacts
Public ContactKiyoshi Yashiro
Keio University, School of Medicine Depertment of Dermatology
Outcome results
None listed