UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020329 |
|---|---|
| Receipt number | 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 18:04:57 |
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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
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
nagasaka.phv@tmd.ac.jp
Sponsor or person
Institute
The strategic study group to establish evidences for the treatment guidelines of intractable vasculitis
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
