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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045936
Receipt No. R000052437
Scientific Title Japan Neuroimmune Disease Registry
Date of disclosure of the study information 2021/11/20
Last modified on 2021/10/30

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Basic information
Public title Japan Neuroimmune Disease Registry
Acronym JANIMA
Scientific Title Japan Neuroimmune Disease Registry
Scientific Title:Acronym JANIMA
Region
Japan

Condition
Condition Neuroimmune Disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We will clarify the natural history and prognostic factors of neuroimmune diseases by accumulating and reviewing clinical information over a long period of time.
Basic objectives2 Others
Basic objectives -Others We will establish a system to enable efficient recruitment of patients for clinical trials. This will contribute to the development and establishment of new treatment methods for neuroimmune diseases in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The course of clinical endpoints mainly used for each neuroimmune disease.
Key secondary outcomes 1. EQ-5D-5L
2. Treatment response
3. Frequency of adverse events

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria As follows:
1) Chronic inflammatory demyelinating polyneuropathy (CIDP): Patients who diagnosed the EFNS/PNS diagnostic criteria 2010 definite, probable, possible
2) Patients who have given written consent to participate in the study
Key exclusion criteria Patients deemed inappropriate for inclusion by the investigator.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kuwabara
Organization Graduate School of Medicine and School of Medicine, Chiba University
Division name Department of Neurology, Professor
Zip code 2608677
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL 0432262126
Email kuwabara-s@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Aotsuka
Organization Graduate School of Medicine and School of Medicine, Chiba University
Division name Department of Neurology
Zip code 2608677
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL 0432262126
Homepage URL https://www.janima.org
Email info@janima.org

Sponsor
Institute The Japanese Society for Neuroimmunology
Institute
Department

Funding Source
Organization Department of Neurology, Graduate School of Medicine and School of Medicine, Chiba University
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2021 Year 11 Month 20 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 Preinitiation
Date of protocol fixation
2021 Year 08 Month 26 Day
Date of IRB
2021 Year 08 Month 26 Day
Anticipated trial start date
2021 Year 11 Month 20 Day
Last follow-up date
2041 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Although the research period is permanent, ethical review approval and research permission will be obtained every five years.

Management information
Registered date
2021 Year 10 Month 30 Day
Last modified on
2021 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052437

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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