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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003927
Receipt No. 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

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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
Email

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
Email watarufu@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Dermatology, Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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