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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026004
Receipt No. R000029850
Scientific Title Safety evaluation study about rituximab therapy for refractory pemphigus
Date of disclosure of the study information 2017/03/08
Last modified on 2018/08/07

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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 10

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

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Tanaka
Organization Keio University, School of Medicine
Division name Depertment of Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3823
Homepage URL
Email ryotanaka@z8.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
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
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
Anticipated trial start date
2017 Year 05 Month 08 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
2017 Year 02 Month 04 Day
Last modified on
2018 Year 08 Month 07 Day


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

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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