UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003927 |
|---|---|
| Receipt number | R000004720 |
| Scientific Title | Therapeutic trial of rituximab in the treatment of patients with recalcitrant epidermolysis bullosa acquisita |
| Date of disclosure of the study information | 2010/08/20 |
| Last modified on | 2012/01/20 15:28:37 |
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Basic information
Public title
Therapeutic trial of rituximab in the treatment of patients with recalcitrant epidermolysis bullosa acquisita
Acronym
Rituximab in the treatment of epidermolysis bullosa acquisita
Scientific Title
Therapeutic trial of rituximab in the treatment of patients with recalcitrant epidermolysis bullosa acquisita
Scientific Title:Acronym
Rituximab in the treatment of epidermolysis bullosa acquisita
Region
| Japan |
Condition
Condition
epidermolysis bullosa acquisita
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to examine the efficacy and side effects of the monoclonal antibody anti-CD20 (rituximab) on epidermolysis bullosa acquisita
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate the disease activity and therapeutic response according to the pemphigus disease area index (PDAI) every one month after the end of the treatment.
Key secondary outcomes
We examine peripheral blood T/B cell subset(CD3+CD4+ T cells, CD3+CD8+ T cells, CD19+B cells), immunoglobulins(IgG, IgA, IgM), anti-type VII collagen every one month after the end of the treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four intravenous infusion of 375mg/m2 of rutuximab will be given at weekly intervals.
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
Patients with recalcitrant epidermolysis bullosa acquisita who meet the following criteria;
1) resistant to combined therapy with prednisolone more than 40mg/d and immuno-suppressant(cyclophosphamide, azathioprine, cyclosporine)
2) resistant to combined therapy with prednisolone more than 40mg/d and plasma exchange or intravenous immunoglobulins.
3) patients with severe side effects due to long-term treatment with steroid.
4) patients who cannot tolerate treatment with high-dose steroid due to complications including diabetes mellitus.
Patients who submitted a signed informed consent are eligible to the trial.
Key exclusion criteria
Patients with severe infection, type B hepatitis and severe hematological diseases will be excluded.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp/med
watarufu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
http://www.kawasaki-m.ac.jp/med
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kawasaki-m.ac.jp/med
Number of participants that the trial has enrolled
Results
Two patients with EBA were enrolled in this study and treated with rituximab and low dose steroid. Skin and oral lesions improved quite slowly after 67 weeks in case 1, while oral lesions and the lesions on hands and face showed slight improvement after 37 weeks in case 2. Anti-type VII collagen antibody ELISA index values declined consecutively from 106.3 to 20.0 in case 1 and from 125.4 to 26.5 in case 2, respectively. Although skin fragility still remains in both patients, the rituximab treatment combined with low dose steroid may be a safe, valuable adjuvant treatment regimen for recalcitrant EBA.
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 | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 20 | Day |
Last modified on
| 2012 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
