UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015451 |
|---|---|
| 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 |
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Basic information
Public 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
Acronym
Rtx-BD Trial 2
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
Scientific Title:Acronym
Rtx-BD Trial 2
Region
| Japan |
Condition
Condition
Pemphigus, Pemphigoid
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of rituximab treatment for steroid resistant autoimmune bullous disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) A rate of severe adverse events, beyond CTCAE grade 3.
2) A rate of remission
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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.
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Amagai |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
amagai@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Yamagami |
Organization
Keio University School of Medicine
Division name
Depertment of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
yamagamijun@a8.keio.jp
Sponsor or person
Institute
Department of Dermatology,
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 16 | Day |
Last modified on
| 2017 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017964
