Multiple SclerosisNIDBaseNCT06443333
National, Multicentric Registry Study on Neuroimmunological Diseases in China
An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- What is being tested?
- Data collection and follow-up observation and Data collection
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients and healthy volunteers from China
Who may be able to join
- Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions:
- Multiple Sclerosis (the criteria followed the Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria)
- NMO Spectrum Disorder (the criteria followed the Diagnosis and Treatment Guidelines for Optic Neuromyelitis Spectrum Disorders in China 2016)
- Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (the criteria followed the Consensus of Chinese Experts on Diagnosis and Treatment of Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Diseases)
- Myasthenia Gravis (the criteria followed the Guidelines for the Diagnosis and Treatment of Myasthenia Gravis in China 2020)
- Autoimmune Encephalitis (the criteria followed the China Expert Consensus on Diagnosis and Treatment of Autoimmune Encephalitis 2017)
- Acute Disseminated Encephalomyelitis (the criteria are based on the article titled "Acute disseminated encephalomyelitis" 2007).
- Healthy adults who underwent a physical examination at the Physical Examination Center of Xuanwu Hospital, Capital Medical University
Who cannot join
- Women during pregnancy or lactation.
- Patients with other neurological diseases or serious mental diseases.
- Patients with serious liver and kidney function or other important organ dysfunction.
- Unable to cooperate with follow-up work and venous blood collection due to poor compliance of patients or healthy volunteers, or incomplete clinical and imaging data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing, Beijing Municipality, 100053
Junwei Hao, MD, 01083198277, haojunwei@vip.163.com
About this study
The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.
Read the detailed description
The purposes of this study are:(1)Establishing a clinical neuroimmune disease research cohort.(2)Collecting the blood, cerebrospinal fluid and other biological samples of the enrolled patients to discover and detect the new neural antibodies, so as to facilitate the diagnosis of related diseases.(3) Conducting in-depth exploration of the Genetic material of patients with neuroimmune diseases and healthy volunteers with second-generation sequencing technology, discovering the pathogenic genes and the mechanism of disease progression.The enrolled patients will be collected Clinical and therapeutic information. Blood and cerebrospinal fluid from the patients will be collected for sequencing analysis and antibody detection. They will also receive the 2-year follow-up with collection of basic clinical information, cognitive function, EDSS score, etc. Healthy volunteers will have their blood collected for sequencing analysis.
Finish the gene sequencing analysis of blood samples from enrolled patients and healthy volunteers to establish the disease gene database and the reference gene database of the healthy population and find the unique expression quantitative trait loci (eQTL) in China, so as to clarify the pathogenic genes and the key mechanism of neuroimmune disease occurrence and development.
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Myasthenia Gravis, Autoimmune Encephalitis, Acute Disseminated Encephalomyelitis
- Being tested
- Data collection and follow-up observation, Data collection
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Myasthenia Gravis, Autoimmune Diseases of the Nervous System, Encephalomyelitis, Acute Disseminated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and follow-up observationOther
At the time of enrollment, the patient's biological samples are collected to obtain genetic information. Following enrollment, trained investigators carry out a 2-year follow-up observation through face-to-face, telephone call or online visits. During the follow-up, basic clinical information, laboratory tests, imaging examinations, neurophysiology, clinical classification, medication use, and scale assessments are collected.
Data collectionOther
Collect demographic and genetic information from healthy volunteers upon enrollment.
| Study group | Role | What they receive |
|---|---|---|
| neuroimmune diseases patient | Patients diagnosed with neuroimmune diseases by a neurologist. Receives: Other: Data collection and follow-up observation | |
| Health Volunteers | Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual recurrence rate
Whether there is recurrence in patients followed up at 12 and 24 months after enrollment
Measured: At 12 and 24 months after enrollment
Secondary outcomes (8)
Change in Expanded Disability Status Scale scores (EDSS)
Change from baseline in Expanded Disability Status Scale scores (EDSS，range from 0 to 10 points, with a higher score indicating a more severe degree of neurological impairment).
Measured: At 6,12,18,24 months after enrollment
Change in MRI of head, optic nerve and spinal cord
whether there are New or enlarged lesions in T1WI, T2WI, T2 FLAIR, Sag bravo, DTI, and BOLD MRI of head, optic nerve and spinal cord in neuroimmune disease patients.
Measured: At 6,12,18,24 months after enrollment
Change in serum and CSF autoimmune antibody status
Collect the patient's serum and cerebrospinal fluid to measure the types and concentrations of autoantibodies. Note any changes compared to the baseline.
Measured: At 6,12,18,24 months after enrollment
Change in Activity of Daily Living Scale (ADL)
Change from baseline in Activity of Daily Living Scale (ADL, range from 14 to 56 points, with higher scores indicating poorer daily life abilities).
Measured: At 6,12,18,24 months after enrollment
Change in the relative power spectral density
Change from baseline in the relative power spectral density of the delta and theta bands in patients.
Measured: At 6,12,18,24 months after enrollment
Changes in Symbol Digit Modalities Test (SDMT)
Change from baseline in Symbol Digit Modalities Test (SDMT, scores range from 0 to 110, with lower scores indicating more severe cognitive impairment).
Measured: At 6,12,18,24 months after enrollment
Changes in Montreal Cognitive Assessment Test (MoCA)
Change from baseline in Montreal Cognitive Assessment Test (MoCA, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment).
Measured: At 6,12,18,24 months after enrollment
changes in Mini-Mental Status Exam (MMSE)
Change from baseline in Mini-Mental Status Exam (MMSE, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment.)
Measured: At 6,12,18,24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Dec 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443333
- Sponsor's protocol ID
- XWZC20210115
- Acronym
- NIDBase
- Status last verified
- Apr 2024
- First submitted
- 10 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Han J, Xia J, Lin M, Chen T, Ruan S, Wang Q, Men Y, Gao R, Zheng H, Li J, Qi Y, Chen S, Wang Y, Tang Y, Li D, Yang X, Qiu Z, Liu Z, Dong H, Zhao Y, Hao J. Chinese neuroimmunological disease (NIDBase) cohort study: cohort profile. BMJ Open. 2026 Jan 8;16(1):e099386. doi: 10.1136/bmjopen-2025-099386.
PubMed 41506767
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentric Registry Study on Neuroimmunological Diseases in China
- ClinicalTrials.gov ID
- NCT06443333
- Acronym / sponsor ID
- NIDBase / XWZC20210115
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Myasthenia Gravis, Autoimmune Encephalitis, Acute Disseminated Encephalomyelitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.
Detailed description
The purposes of this study are:(1)Establishing a clinical neuroimmune disease research cohort.(2)Collecting the blood, cerebrospinal fluid and other biological samples of the enrolled patients to discover and detect the new neural antibodies, so as to facilitate the diagnosis of related diseases.(3) Conducting in-depth exploration of the Genetic material of patients with neuroimmune diseases and healthy volunteers with second-generation sequencing technology, discovering the pathogenic genes and the mechanism of disease progression.The enrolled patients will be collected Clinical and therapeutic information. Blood and cerebrospinal fluid from the patients will be collected for sequencing analysis and antibody detection. They will also receive the 2-year follow-up with collection of basic clinical information, cognitive function, EDSS score, etc. Healthy volunteers will have their blood collected for sequencing analysis.
Finish the gene sequencing analysis of blood samples from enrolled patients and healthy volunteers to establish the disease gene database and the reference gene database of the healthy population and find the unique expression quantitative trait loci (eQTL) in China, so as to clarify the pathogenic genes and the key mechanism of neuroimmune disease occurrence and development.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuroimmune diseases patient | – | Other: Data collection and follow-up observationPatients diagnosed with neuroimmune diseases by a neurologist. |
| Health Volunteers | – | Other: Data collectionHealthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and healthy volunteers from China
Key inclusion criteria (8 listed)
- Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions:
- Healthy adults who underwent a physical examination at the Physical Examination Center of Xuanwu Hospital, Capital Medical University
Key exclusion criteria (4 listed)
- Women during pregnancy or lactation.
- Patients with other neurological diseases or serious mental diseases.
- Patients with serious liver and kidney function or other important organ dysfunction.
- Unable to cooperate with follow-up work and venous blood collection due to poor compliance of patients or healthy volunteers, or incomplete clinical and imaging data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection and follow-up observationAt the time of enrollment, the patient's biological samples are collected to obtain genetic information. Following enrollment, trained investigators carry out a 2-year follow-up observation through face-to-face, telephone call or online visits. During the follow-up, basic clinical information, laboratory tests, imaging examinations, neurophysiology, clinical classification, medication use, and scale assessments are collected. | Other | neuroimmune diseases patient |
| Data collectionCollect demographic and genetic information from healthy volunteers upon enrollment. | Other | Health Volunteers |
Primary outcome
Annual recurrence rate
Time frame: At 12 and 24 months after enrollment
Whether there is recurrence in patients followed up at 12 and 24 months after enrollment
8 secondary outcomes
Change in Expanded Disability Status Scale scores (EDSS)
Time frame: At 6,12,18,24 months after enrollment
Change in MRI of head, optic nerve and spinal cord
Time frame: At 6,12,18,24 months after enrollment
Change in serum and CSF autoimmune antibody status
Time frame: At 6,12,18,24 months after enrollment
Change in Activity of Daily Living Scale (ADL)
Time frame: At 6,12,18,24 months after enrollment
Change in the relative power spectral density
Time frame: At 6,12,18,24 months after enrollment
Changes in Symbol Digit Modalities Test (SDMT)
Time frame: At 6,12,18,24 months after enrollment
Changes in Montreal Cognitive Assessment Test (MoCA)
Time frame: At 6,12,18,24 months after enrollment
changes in Mini-Mental Status Exam (MMSE)
Time frame: At 6,12,18,24 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 41506767Zhang M, Han J, Xia J, Lin M, Chen T, Ruan S, Wang Q, Men Y, Gao R, Zheng H, Li J, Qi Y, Chen S, Wang Y, Tang Y, Li D, Yang X, Qiu Z, Liu Z, Dong H, Zhao Y, Hao J. Chinese neuroimmunological disease (NIDBase) cohort study: cohort profile. BMJ Open. 2026 Jan 8;16(1):e099386. doi: 10.1136/bmjopen-2025-099386.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junwei Hao, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual recurrence rate (time frame: At 12 and 24 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.