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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020329
Receipt No. R000023477
Scientific Title Remission induction with rituximab in Japanese patients with ANCA-associated vascutlitis
Date of disclosure of the study information 2016/01/25
Last modified on 2017/06/20

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Basic information
Public title Remission induction with rituximab in Japanese patients with ANCA-associated vascutlitis
Acronym RemIRIT
Scientific Title Remission induction with rituximab in Japanese patients with ANCA-associated vascutlitis
Scientific Title:Acronym RemIRIT
Region
Japan

Condition
Condition ANCA-associated vasculitis
Classification by specialty
Medicine in general Pneumology Nephrology
Neurology Clinical immunology Ophthalmology
Dermatology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of AAV patients treated with rituximab
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes remission rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 MPA and GPA patient treated with rituximab
Key exclusion criteria patient lower than 20 years-old
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Arimura
Organization Kyorin university
Division name Dept. of Nephrology and Rheumatology
Zip code
Address 6-20-2, Shinkawa, Mitaka-city
TEL 0422-47-5511
Email amed-vas@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Nagasaka
Organization Tokyo Medical and Dental University
Division name Dept. of Pharmacovigilance
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Homepage URL
Email nagasaka.phv@tmd.ac.jp

Sponsor
Institute The strategic study group to establish evidences for the treatment guidelines of intractable vasculitis
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2016 Year 01 Month 25 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study

Management information
Registered date
2015 Year 12 Month 24 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023477

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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