UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study of autoimmune bullous disease with imatinib
Acronym	Treatment of autoimmune bullous disease with imatinib
Scientific Title	Intervention study of autoimmune bullous disease with imatinib
Scientific Title:Acronym	Treatment of autoimmune bullous disease with imatinib
Region	Japan

Condition
Condition	Autoimmune bullous disease
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study will demonstrate that imatinib's extravascular antibody transfer inhibitory action improves symptomatic improvement of autoimmune bullous disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of severity of autoimmune bullous disease
Key secondary outcomes	Changes in autoantibody titer in blood Changes in antibody titer in body fluid (saliva, content of blisters)

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	After diagnosis of pemphigus group or pemphigoid group, oral administration of prednisolone is started according to the following: #1. In case of the initial onset: 0.5 mg/kg/day #2. In case of recurrence/relapse, keep the preceding dose. Within 14 days of starting steroid therapy (when the hospital bed is secured), imatinib 400 mg twice daily after dinner and breakfast. Terminate imatinib at day 7.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	#1 Diagnosed as pemphigus group or pemphigus group. #2 Those not planning treatment with steroid pulse therapy or IVIG therapy. #3 The age at the time of consent acquisition is over 20 years old. #4 The latest blood test and liver function test within 4 weeks before registration satisfy all of the following. Number of neutrophils >= 1,500 / mm3 Platelet count >= 75,000 / mm3 AST (GOT) <120 IU / L ALT (GPT) <120 IU / L Total bilirubin <1.8 mg / dL 5) In the case of men, those agreeing to contrace up to 4 weeks after the start of the study drug administration from the date of final administration of the test drug. In the case of women, one after surgical contraceptive surgery such as postmenopausal (more than 1 year since the last menstruation), or bilateral oophorectomy. 6) With regard to participation in this study, written informed consent has been obtained from the patient himself.
Key exclusion criteria	1) There is a history that has allergy to Imatinib. 2) It has one of the following complications. Serious heart disease or its past liver disorder, renal disorder 3) Consent Acknowledging participation in other exams within 4 weeks before acquisition. 4) In addition, patients judged unsuitable for the trial responsible doctor or shared medical doctor to safely carry out this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenji Kabashima
Organization	Kyoto University Hospital
Division name	Department of Dermatology
Zip code
Address	54 Shogoin-Kawahara-cho, Sakyoku, Kyoto
TEL	075-751-3310
Email	kaba_@_kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Nomura
Organization	Kyoto University Hospital
Division name	Department of Dermatology
Zip code
Address	54 Shogoin-Kawahara-cho, Sakyoku, Kyoto
TEL	075-751-3310
Homepage URL
Email	tnomura_@_kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 17 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	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 01 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	2018 Year 01 Month 17 Day
Last modified on	2018 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035238

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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