China National Registry of Neuro-Inflammatory Diseases
CNRID
1 other identifier
observational
10,000
1 country
1
Brief Summary
Central nervous system (CNS) idiopathic inflammatory demyelinating diseases (IDD) are mainly diseases caused by autoimmune factors that result in CNS demyelination damage and loss. It tends to accumulate in the brain, spinal cord and optic nerves. Multiple sclerosis (MS), clinically isolated syndrome (CIS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and acute disseminated encephalomyelitis (ADEM) are all common IDDs of the CNS. Besides, primary angiitis of the central nervous system (PACNS), autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A), etc. may also be included because they are important differential diagnoses. This study will establish a large prospective cohort study database of Chinese IDD, which will record detailed electronic information on IDD patients, including demographic and socioeconomic data, medical history, clinical information, medication, and relevant examination results. The long-term observational study will be used to understand the natural history of disease, disability progression rates, imaging and biological indicators, long-term treatment approaches and prognosis of Chinese patients with IDD, to find predictive markers for IDD progression and prognosis, and to identify factors that influence the treatment and prognosis of patients with IDD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
July 21, 2023
July 1, 2023
4.9 years
November 8, 2021
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Annual relapse rate (ARR) between baseline and follow-up in patients with IDD
a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
baseline up to 5 years
Change in EDSS scores of patients with IDD between baseline and follow-up over time
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. The higher the score, the worse the clinical symptoms.
baseline, Month 6, Month12, Month18, Month24, Month30, Month36, Month42, Month48, Month54, Month60
Secondary Outcomes (12)
The brain structural change over time between the baseline MRI and the follow-up MRIs
baseline, year1, year2, year3, year4, year5.
The spinal cord change over time between the baseline MRI and the follow-up MRIs.
baseline, year1, year2, year3, year4, year5.
Change of the central vein sign at 7T MRI.
baseline, year1, year2, year3, year4, year5.
Change of rim of iron at 7T MRI.
baseline, year1, year2, year3, year4, year5.
Change in High-contrast Letter Acuity (HCLA) over time at baseline and during follow-up in patients with IDD
baseline, year1, year2, year3, year4, year5.
- +7 more secondary outcomes
Study Arms (4)
MS/CIS
Diagnosis of MS and CIS based on the 2017 McDonald MS diagnostic criteria.
ADEM
Diagnosis of ADEM based on the 2012 IPMSSG diagnostic criteria for ADEM
MOGAD
Diagnosis of MOGAD based on the 2020 Chinese Expert Consensus.
NMOSD
diagnosis of NMOSD according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria.
Interventions
This study does not limit treatment methods. Patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. Immunomodulatory therapies are necessary for the remission stage. All drugs are used in accordance with relevant guidelines.
Eligibility Criteria
10000 IDD patients are planned to be recruited from many sites throughout the country.
You may qualify if:
- \. No requirement for age and sex
- \. Need to meet the diagnosis of at least one IDD (clinically isolated syndrome (CIS)/multiple sclerosis (MS)/neuromyelitis optica spectrum disorder (NMOSD)/MOG antibody-associated disease (MOGAD)/acute disseminated encephalomyelitis (ADEM).
- \. Signed informed consent form.
You may not qualify if:
- Those with severe mental disease unable to cooperate with the examination and/or follow-up.
- Any patient (or the patient's legal representative) who is unable or refuses to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100069, China
Related Publications (1)
Xu Y, Meng H, Fan M, Yin L, Sun J, Yao Y, Wei Y, Cong H, Wang H, Song T, Yang CS, Feng J, Shi FD, Zhang X, Tian DC. A Simple Score (MOG-AR) to Identify Individuals at High Risk of Relapse After MOGAD Attack. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200309. doi: 10.1212/NXI.0000000000200309. Epub 2024 Sep 9.
PMID: 39250723DERIVED
Biospecimen
blood and cerebral spinal fluid
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
December 13, 2021
Study Start
December 15, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
July 21, 2023
Record last verified: 2023-07