ClinicalTrials.gg
RecruitingNCT06443333NIDBaseUpdated Jun 5, 2024

National, Multicentric Registry Study on Neuroimmunological Diseases in China

An observational study in Multiple Sclerosis, NMO Spectrum Disorder and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
7,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 59 studies in Multiple Sclerosis with a site in China — 31 open to participants now, 36 under way, 5 of them phase 3. Multiple Sclerosis · China.

Planned enrollment
4th of 14
7,000 · median 375
Started
2020
with 4 others
Observational
14 of 59
10 open now
Primary completion
2024-12
later than 0 of 35 live
Registered
28th of 59
by date
Lead sponsor
4 of 59
Xuanwu Hospital, Beijing

Among the 59 studies in Multiple Sclerosis with a site in China, this one is the 4th largest by planned enrollment of the 14 observational ones that give a count, is one of 5 that started in 2020, is one of 14 observational ones, reaches primary completion later than 0 of the 35 other live ones, and was the 28th registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

31 of the 59 studies in Multiple Sclerosis with a site in China are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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 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.

03

Conditions studied

  • Multiple Sclerosis
  • NMO Spectrum Disorder
  • Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
  • Myasthenia Gravis
  • Autoimmune Encephalitis
  • Acute Disseminated Encephalomyelitis
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients and healthy volunteers from China

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)
    • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
7,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • neuroimmune diseases patient

    Patients diagnosed with neuroimmune diseases by a neurologist.

    Other: Data collection and follow-up observation

  • Health Volunteers

    Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center.

    Other: Data collection

Interventions

  • OtherData collection and follow-up observation

    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.

  • OtherData collection

    Collect demographic and genetic information from healthy volunteers upon enrollment.

06

What researchers measure

Primary outcomes

  1. Annual recurrence rate

    Whether there is recurrence in patients followed up at 12 and 24 months after enrollment

    Time frame: At 12 and 24 months after enrollment

Secondary outcomes

  1. 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).

    Time frame: At 6,12,18,24 months after enrollment

  2. 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.

    Time frame: At 6,12,18,24 months after enrollment

  3. 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.

    Time frame: At 6,12,18,24 months after enrollment

  4. 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).

    Time frame: At 6,12,18,24 months after enrollment

  5. Change in the relative power spectral density

    Change from baseline in the relative power spectral density of the delta and theta bands in patients.

    Time frame: At 6,12,18,24 months after enrollment

  6. 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).

    Time frame: At 6,12,18,24 months after enrollment

  7. 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).

    Time frame: At 6,12,18,24 months after enrollment

  8. 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.)

    Time frame: At 6,12,18,24 months after enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2020 (actual). Primary completion is estimated for Dec 2024, 48 months after the start.

Of 335 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 81. This study's planned 48 months is above that.

Counting every sponsor, half of 426 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2024
First posted
Jun 5, 2024
StartActual
Dec 1, 2020
Primary completionEst.
Dec 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Jun 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06443333
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Dec 1, 2020
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jun 5, 2024

Study contacts

Junwei Hao, MD
Contact
haojunwei@vip.163.com
01083198277
Junwei Hao, MD
principal investigator · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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