UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin. Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2
Title of the study (Brief title)	Rtx-BD Trial 2
Region	Japan

Condition
Condition	Pemphigus, Pemphigoid
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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,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 375mg/sqm, q1w, 4 doses. Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48
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	1) Patients who are treated with PSL over 10mg/day and relapsed during steroid taper. 2) Patients who can be hospitalized at least 28 days. If PDAI or BPDAI is under 15, the minimum length of stay in a hospital is 10 days. 3) Patients who have not been treated with high-dose intravenous Ig, plasma exchange, steroid pulse therapy and new immunosuppressant within 30 days before enrollment.
Key exclusion criteria	1) Pregnancy 2) Allergy for biologics 3) Severe organ disorder 4) History of other diseases which need systemic steroid treatment 5) Infections 6) Malignancy
Target sample size	20

Research contact person
Name of lead principal investigator	Masayuki Amagai
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	amagai@a7.keio.jp

Public contact
Name of contact person	Jun Yamagami
Organization	Keio University School of Medicine
Division name	Depertment of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	yamagamijun@a8.keio.jp

Sponsor
Institute	Department of Dermatology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School
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）、北海道大学病院（北海道）、久留米大学病院（福岡県）、岡山大学病院（岡山県）、川崎医大附属川崎病院（岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 16 Day
Last modified on	2017 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017964