UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.
Title of the study (Brief title)	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	Masayuki Amagai
Organization	Keio University School of Medicine
Division name	Dermatology
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	amagai@a7.keio.jp

Public contact
Name of contact person	Julia Miyamoto
Organization	Keio University School of Medicine
Division name	Dermatology
Address	35 Shinanomachi Shinjyuku-ku Tokyo
TEL	03-3353-1211
Homepage URL
Email	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005293