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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015451 |
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Date of registration:
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25/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin. Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2
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Scientific title:
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Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin. Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2 - Rtx-BD Trial 2 |
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Date of first enrolment:
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2014/11/13 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017964 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Jun Yamagami |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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yamagamijun@a8.keio.jp |
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Affiliation:
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Keio University School of Medicine Depertment of Dermatology |
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Name:
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Masayuki Amagai |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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amagai@a7.keio.jp |
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Affiliation:
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Keio University School of Medicine Department of Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Pregnancy 2) Allergy for biologics 3) Severe organ disorder 4) History of other diseases which need systemic steroid treatment 5) Infections 6) Malignancy
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Pemphigus, Pemphigoid
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Intervention(s)
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Rituximab 375mg/sqm, q1w, 4 doses. Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48
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Primary Outcome(s)
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1) A rate of severe adverse events, beyond CTCAE grade 3. 2) A rate of remission
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Source(s) of Monetary Support
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Keio University School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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