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Overview of the Neuroimmunological Disease Registry Study

Study TitleNeuroimmunological Disease Registry [RADDAR-J[79]]
Principal InvestigatorSonoko Misawa, MD, PhD
Department of Neurology, Institute of Science Tokyo Hospital

Purpose of the Study

This registry aims to continuously collect biosamples and clinical data from patients with neuroimmunological diseases in order to:

  • Gain insights into disease characteristics 
  • Capture real-world evidence on treatment practices 
  • Enable efficient recruitment of eligible patients for clinical trials 

Ultimately, the goal is to contribute to the rapid development of new therapeutic interventions.

Target Diseases

  • Chronic inflammatory demyelinating polyneuropathy (CIDP) 
  • Nodopathy 
  • Anti-MAG antibody-associated neuropathy 
  • Multifocal motor neuropathy (MMN)

Study Design

After initial enrollment, subjects will be followed up annually in principle.
Both clinical data and biosamples will be collected longitudinally.

Study Duration

Indefinite (renewed every 5 years)

Ethical Review

This study is centrally referred to and approved by the
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee.

  • All submission steps and procedures of the Ethics Committee are handled by the administration hub of the registry 
  • As such, administrative burden on participating institutions is minimized 
  • Conflict of interest (COI) management is conducted at each participating institution pursuant to the institution’s review or self-reporting procedures

Study Implementation Structure

  • The registry is operated under the supervision of the Japanese Society for Neuroimmunology 
  • Ongoing support is provided by the Ministry of Health, Labour and Welfare research group:
    “Validation of diagnostic criteria, severity classification, and guidelines for neuroimmunological diseases based on evidence, and evaluation of patient QOL” 
  • The role of the administrative hub of the registry is assumed and pursued by kizuna,  a General Incorporated Association, at the request of the Japanese Society for Neuroimmunology

Funding Source

  • Ministry of Health, Labour and Welfare (Japan):
    Intractable Diseases Policy Study Program 
  • Pharmaceutical companies

Flow of Patient Data and Biosamples

Clinical data and biosamples collected from patients are:

  1. Transferred via participating institutions 
  2. Stored in:
    • Electronic Case Report Forms (eCRF) at the administrative hub of the registry 
    • Biorepository 
  3. Made available to (for secondary exploitation):
    • Those external research institutions or companies which submit requests 
    • If and when reviewed and approved by:
      • the Registry Review Committee of the Japanese Society for Neuroimmunology
      • (if necessary) the Japanese Society for Neuroimmunology 
      • (if necessary) the Rare Disease Platform 
  4. Details of enrollment steps are set forth and implemented per the standard operating procedures distributed separately by the administrative hub of the registry.

Data Collected in This Study

Annual follow-up on subjects is planned after initial enrollment.

Itemized List of Clinical Data Collected (excerpt):

  • Subject name and contact information 
  • Date of birth and sex 
  • Date of onset, age at onset, diagnosis date, treatment starting date 
  • EQ-5D-5L (quality of life measurement) 
  • Medical history, comorbidities, family history 
  • Smoking history, pregnancy/childbirth history 
  • CIDP diagnostic category (possible / probable / definite) 
  • Clinical phenotype (typical, multifocal, distal, sensory, motor) 
  • Clinical symptoms:
    • Muscle weakness 
    • Sensory disturbance 
    • Ataxia 
    • Tremor 
    • Pain 
    • Cranial nerve symptoms 
  • Functional and severity scales:
    • ONLS 
    • RODS 
    • Grip strength 
    • MRC sum score 
  • Test findings:
    • Nerve conduction studies 
    • Blood biochemistry 
    • Autoantibodies (e.g., anti-NF155 antibody) 
    • Cerebrospinal fluid analysis 
    • Nerve ultrasonic test 
    • Peripheral nerve MRI 
  • Nerve biopsy findings 
  • Treatments:
    • Medications 
    • Treatment response 
    • Duration
  • Adverse events related to maintenance therapy

Benefits and Feedback

For Participating Physicians

  • Access to registry data and biosamples:
    Eligible for consultation with the administrative hub with respect to the data or biosamples maintained by the registry when there is need of prospective or retrospective studies; development of study protocol and review and approval by the Registry Review Committee are required for the study
  • Newsletter:
    Regular updates on disease-specific information 
  • Consultation for difficult cases:
    Opportunity to consult with experts specializing in the relevant disease(in preparation) 
  • Clinical trial opportunities:
    This registry is contemplated to draw interest in proactively exploiting the registry for recruitment of subjects into new clinical trials or other ventures; researchers of participating institutions have efficient access to information on upcoming trials

For Patients

  • Newsletter:
    Regular updates tailored for patients, e.g., updates on the diseases affecting patients (the contents of which vary from those of the newsletter for participating physicians)
    (Content differs from that provided to physicians) 
  • Access to clinical trial information:
    Enrollment facilitates opportunities to learn about new clinical studies/trials

Overview of the Neuromyelitis Optica Spectrum Disorder (NMOSD) Registry　（Neuroimmunological Disease Registry）

Study TitleNeuromyelitis Optica Spectrum Disorder Registry
(Neuroimmunological Disease Registry [RADDAR-J[79]])
Principal InvestigatorIchiro Nakashima, MD, PhD
Department of Neurology, Tohoku Medical and Pharmaceutical University

Purpose of the Study

This registry aims to continuously collect biosamples and clinical data from patients with neuroimmunological diseases in order to:

  • Gain insights into disease characteristics 
  • Capture real-world evidence on treatment practices 
  • Enable efficient recruitment of eligible patients for clinical trials 

Ultimately, the goal is to contribute to the rapid development of new therapeutic interventions.

Target Diseases

  • Neuromyelitis optica spectrum disorder (NMOSD)
  • Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

Study Design

After initial enrollment, subjects will be followed up annually in principle.
Both clinical data and biosamples will be collected longitudinally.

Study Duration

Indefinite (renewed every 5 years)

Target Enrollment Size

1,000 patients
Collection of biosamples is planned to be completed upon reaching approximately 600 enrolled subjects. After this point, only clinical data will continue to be collected.

Ethical Review

This study is centrally referred to and approved by the
Kyoto University (Graduate School and Faculty of Medicine, Ethics Committee.

  • All submission steps and procedures of the Ethics Committee are handled by the institution for which the principal investigator works for and by the administration hub of the registry 
  • As such administrative burden on participating institutions is minimized 
  • Conflict of interest (COI) management is conducted at each participating institution pursuant to the institution’s review or self-reporting procedures

Study Implementation Structure

  • The registry is operated under the supervision of the Japanese Society for Neuroimmunology 
  • Ongoing supported is provided by the Ministry of Health, Labour and Welfare research program:
    “Research contributing to the improvement of medical standards and patient QOL in neuroimmunological diseases” 
  • The role of the administrative hub of the registry is assumed and pursued by kizuna, a General Incorporated Association, at the request of the Japanese Society for Neuroimmunology

Funding Source

  • Ministry of Health, Labour and Welfare (Japan):
    Intractable Diseases Policy Study Program 
  • Chugai Pharmaceutical Co., Ltd.

Flow of Patient Data and Biosamples

Clinical data and biosamples collected from patients are:

  1. Transferred via participating institutions 
  2. Stored in:
    • Electronic Data Capture (EDC) system at the administrative hub of the registry 
    • Biorepository 
  3. Made available to (for secondary exploitation):
    • Those external research institutions or companies which submit requests 
    • If and when reviewed and approved by:
      • the Registry Review Committee of the Japanese Society for Neuroimmunology 
      • (if necessary) the Japanese Society for Neuroimmunology 
      • (if necessary) the Rare Disease Platform 
  4.  Details of enrollment steps are set forth and implemented per the standard operating procedures distributed separately by the administrative hub of the registry.

Data Collected in This Study

Annual follow-up on subjects is planned after initial enrollment.

Biosample collection will be completed after approximately 600 cases; thereafter, only clinical data will be collected.。

Itemized List of Clinical Data Collected

  • Personal information (name, contact details, date of birth, etc.) 
  • Managerial/background information (diagnosis, date of diagnosis, etc.) 
  • Comorbidities 
  • Baseline disease severity 
  • Number of relapses prior to enrollment 
  • Most recent relapse 
  • Test results:
    • AQP4 antibody 
    • MOG antibody 
    • Cerebrospinal fluid analysis 
    • Brain MRI 
    • Spinal cord MRI 
  • Treatment information:
    • Acute-phase treatment 
    • Preventive treatment 
    • Past treatments 
  • EQ-5D-5L 
  • Adverse events 
  • Relapse events (including postpartum relapses)

Benefits and Feedback

For Participating Physicians

  • Access to registry data and biosamples:
    Eligible for consultation with the administrative hub with respect to the data or biosamples maintained by the registry when there is need of prospective or retrospective studies; development of study protocol and review and approval by the Registry Review Committee are required for the study
  • Newsletter:
    Regular updates on disease-specific information 
  • Consultation for difficult cases:
    Opportunity to consult with experts specializing in the relevant disease(in preparation) 
  • Clinical trial opportunities:
    This registry is contemplated to draw interest in proactively exploiting the registry for recruitment of subjects into new clinical trials or other ventures; researchers of participating institutions have efficient access to information on upcoming trials

For Patients

  • Newsletter:
    Regular updates tailored for patients, e.g., updates on the diseases affecting patients (the contents of which vary from those of the newsletter for participating physicians)
    (Content differs from that provided to physicians) 
  • Access to clinical trial information:
    Enrollment facilitates opportunities to learn about new clinical studies/trials