UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026004 |
|---|---|
| Receipt number | 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 | 2021/03/04 18:59:20 |
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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
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
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
yashikiyo@keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029850
| Research Plan | |
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| Registered date | File name |
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