UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation study about rituximab therapy for refractory pemphigus
Acronym	Rituximab therapy for refractory pemphigus
Scientific Title	Safety evaluation study about rituximab therapy for refractory pemphigus
Scientific Title:Acronym	Rituximab therapy for refractory pemphigus
Region	Japan

Condition
Condition	pemphigus
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety of the rituximab therapy for refractory pemphigus
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety(CTCAE)
Key secondary outcomes	efficacy(remission, PDAI, antibody titer)

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	Infuse rituximab 1000mg/body twice biweekly
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) Patient diagnosed as pemphigus and relapse disease taking corticosteroids more then PSL 10mg/day 2) PDAI>=1 3) Greater than or equal to 20 years of age and younger than or equal to 80 years of age. 4) Able to understand and sign the Informed Consent Document.
Key exclusion criteria	1) Women who may possibly be pregnant or pregnant and men who plan to impregnate a woman 2) Allergy to humanized monoclonal antibody and/or murine monoclonal antibody, murine derived component 3) Active major medical illnesses 4) Active infections 5) Past history of infection within 8weeks 6) Past history of taking antibiotics (oral ; within 2weeks, infusion ; 8weeks) 7) Past history of bacteremia within 1 year 8) Past history of deep tissue infections and/or abscess 9) chronic and/or recurrent infections 10) Past history ofPatients who have or had malignancies 11) Past history of alcoholism and/or drug intoxication 12) Patients who have severe psychiatric disease 13) Past history of surgical operation within 4weeks 14) Past history of severe infection during taking immunosuppressive agent 15) vaccinated within 28weeks 16) Have laboratory parameters without Protocol-defined range 17) Infused Rituximab within 24weeks 18) Past history of Rituximab therapy more than 3times 19) taking other investigational drugs 20) ineffectiveness of past Rituximab therapy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takeru Middle name Last name Funakoshi
Organization	Keio University, School of Medicine
Division name	Depertment of Dermatology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3823
Email	takeruf@a8.keio.jp

Public contact
Name of contact person	1st name Kiyoshi Middle name Last name Yashiro
Organization	Keio University, School of Medicine
Division name	Depertment of Dermatology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3823
Homepage URL
Email	yashikiyo@keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Keio University, School of Medicine Funding from patient
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Zenyaku Kogyo Co., Ltd.

IRB Contact (For public release)
Organization	Certified Review Board of Keio
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031180405
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 08 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	2017 Year 01 Month 28 Day
Date of IRB	2017 Year 05 Month 11 Day
Anticipated trial start date	2017 Year 05 Month 11 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 04 Day
Last modified on	2021 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029850