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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-jRCTs031180220
Date of registration: 15/03/2019
Prospective Registration: No
Primary sponsor: Kanaoka Miwa
Public title: Rituximab treatment of blistering disease
Scientific title: Treatment of refractory autoimmuno blistering disease with rituximab
Date of first enrolment: 01/05/2014
Target sample size: 10
Recruitment status: Complete
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs031180220
Study type:  Interventional
Study design:  non-randomized controlled trial, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  N/A
Countries of recruitment
Contacts
Name: Miwa    Kanaoka
Address:  3-9 Fukuura, Kanazawa-ku, Yokohama 221-0004 Kanagawa Japan
Telephone: +81-45-787-2800
Email: kanaokam@yokohama-cu.ac.jp
Affiliation:  Yokohama City University Hospital
Name: Miwa    Kanaoka
Address:  3-9 Fukuura, Kanazawa-ku, Yokohama 221-0004 Kanagawa Japan
Telephone: +81-45-787-2800
Email: kanaokam@yokohama-cu.ac.jp
Affiliation:  Yokohama City University Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Patients who were diagnosed with pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid, with sufficient explanation and obtained research consent as sentences.
Exclusion criteria: Patients diagnosed as inappropriate by the judgment of the doctor.

Age minimum: >= 20age old
Age maximum: < 80age old
Gender: Both
Health Condition(s) or Problem(s) studied
Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid
Intervention(s)
Infusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.
Primary Outcome(s)
Reduction of immunosuppressive agent and steroid dose.
Secondary Outcome(s)
Improvement of clinical symptoms, reduction of antibody titer.
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Michiko Aihara
Ethics review
Status: Approval
Approval date:
Contact:
rinri@yokohama-cu.ac.jp
Yokohama City University Certified Institutional Review Board
+81-45-370-7627
rinri@yokohama-cu.ac.jp
Results
Results available: Yes
Date Posted: 31/03/2023
Date Completed: 01/12/2020
URL:
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