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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004428 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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) |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Research group of rare intractable dermatologial disorder |
Institute | |
Department |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005293 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |