Rituximab therapy for refractory pemphigus
- Conditions
- Refactory PemphigusOther disease of skin or skin tissue
- Registration Number
- JPRN-jRCTs031180405
- Lead Sponsor
- Funakoshi Takeru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
1) Patient diagnosed as pemphigus and relapse disease taking corticosteroids more than 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 24-week safety after Rituximab therapy (CTCAE)
- Secondary Outcome Measures
Name Time Method Efficacy (remission rate, PDAI, antibody titer)