UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004428 |
|---|---|
| Receipt number | R000005293 |
| Scientific Title | Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2017/08/07 21:58:01 |
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Basic information
Public title
Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.
Acronym
Rtx-BD Trial
Scientific Title
Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.
Scientific Title:Acronym
Rtx-BD Trial
Region
| Japan |
Condition
Condition
pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita
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, pemphigus, bullous pemphigoid and epidermolysis bullosa acquisita
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase 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
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)PDAI over 10 at first and also PDAI 10 to 15 after treatment of PSL 1.0 mg/kg/day 2weeks. Patients who cannot be into complete remmision by usual treatment.
2) Over 20 years old
3) Patients who can be hospitalized 28 days.
Key exclusion criteria
Health condition
1) Pregnancy
2) Allergy for biologics
3) Severe organ disorder
4) History of other diseases which need systemic steroid treatment
5) Infections
6) Malignancy
Treatment history
1) Use of biologics
2) Severe adverse events by immunosuppressant (CTCAE over grade 3)
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
Dermatology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
amagai@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Julia Miyamoto |
Organization
Keio University School of Medicine
Division name
Dermatology
Zip code
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
julia19780124@gmail.com
Sponsor or person
Institute
Research group of rare intractable dermatologial disorder
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Okayama University School of Medicine
Kurume University School of Medicine
Hokkaido University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2017 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005293
