Unique ID issued by UMIN | UMIN000015451 |
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Receipt number | R000017964 |
Scientific Title | 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 |
Date of disclosure of the study information | 2014/10/25 |
Last modified on | 2017/10/19 22:32:50 |
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
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
Japan |
Pemphigus, Pemphigoid
Dermatology |
Others
NO
To evaluate safety and efficacy of rituximab treatment for steroid resistant autoimmune bullous disease.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
1) A rate of severe adverse events, beyond CTCAE grade 3.
2) A rate of remission
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Patients who are treated with PSL over 10mg/day and relapsed during steroid taper.
2) Patients who can be hospitalized at least 28 days.
If PDAI or BPDAI is under 15, the minimum length of stay in a hospital is 10 days.
3) Patients who have not been treated with high-dose intravenous Ig, plasma exchange, steroid pulse therapy and new immunosuppressant within 30 days before enrollment.
1) Pregnancy
2) Allergy for biologics
3) Severe organ disorder
4) History of other diseases which need systemic steroid treatment
5) Infections
6) Malignancy
20
1st name | |
Middle name | |
Last name | Masayuki Amagai |
Keio University School of Medicine
Department of Dermatology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
amagai@a7.keio.jp
1st name | |
Middle name | |
Last name | Jun Yamagami |
Keio University School of Medicine
Depertment of Dermatology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
yamagamijun@a8.keio.jp
Department of Dermatology,
Keio University School of Medicine
Keio University School of Medicine
Other
Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School
NO
慶應義塾大学病院(東京都)、北海道大学病院(北海道)、久留米大学病院(福岡県)、岡山大学病院(岡山県)、川崎医大附属川崎病院(岡山県)
2014 | Year | 10 | Month | 25 | Day |
Unpublished
Terminated
2014 | Year | 11 | Month | 13 | Day |
2014 | Year | 11 | Month | 13 | Day |
2014 | Year | 10 | Month | 16 | Day |
2017 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017964
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