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Multiple SclerosisNCT07333196

Tongji NADs Cohort

An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
No active interventions
How many people
1,550 participants
Where
1 siteChina
Study dates
1 Mar 2026to 1 Mar 2037
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study aims to enroll NADs patients meeting inclusion criteria at our center from March 1, 2022 to March 1, 2032. The planned retrospective and prospective cohort will include: 300 multiple sclerosis (MS) cases, 300 AQP4 antibody-positive neuromyelitis optica spectrum disorders (NMDs), 200 MOG antibody-associated diseases, 150 autoimmune encephalitis (AE) cases, 80 immune-mediated peripheral neuropathy (IMPN) cases, 400 myasthenia gravis (MG) cases, and 120 idiopathic inflammatory myopathy (IIM) cases.

Who may be able to join

  • Participants must meet the following eligibility criteria at the time of screening to participate in this study.
  • 1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.
  • 1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.
  • 1.3. Must be diagnosed with one of the following conditions:
  • 1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:
  • ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.
Show all 47Show fewer
  • ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.
  • ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.
  • A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.
  • A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.
  • Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: [1] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) [2] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord [3] OCB positivity.
  • 1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:
  • NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.
  • Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.
  • Note: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy/hypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.
  • MRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1/2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.
  • 1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:
  • A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;
  • If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).
  • Note: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.
  • Typical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or "H" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.
  • The strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.
  • 1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)
  • Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.
  • Diagnostic criteria:
  • Clinical presentation: Acute or subacute onset (<3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.
  • Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2/FLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and/or basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.
  • Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.
  • 1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:
  • AIDP: Essential features include: ① Progressive weakness in the upper and/or lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (<5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.
  • CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.
  • Autoimmune Ranvier node disease:
  • Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.
  • Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.
  • Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140/186 antibody.
  • Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.
  • 1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis
  • Basic conditions
  • ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).
  • ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.
  • Diagnostic criteria:
  • After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.
  • After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.
  • After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).
  • Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.
  • Diagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.
  • 1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR/ACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.

Who cannot join

  • This is an observational study with no specific exclusion criteria.
  • The investigators identified other unexplained factors that may have disqualified participants from enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders

Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.

While randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion/exclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.

Being tested
No active interventions
Medical subject headings
Multiple Sclerosis, Neuromyelitis Optica, Autoimmune Diseases of the Nervous System, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Guillain-Barre Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Myasthenia Gravis, Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No active interventionsOther

    The therapies are based on needs of the participants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EDSS Score

    EDSS Score is the most commonly used in evaluating the neurological functions of patients with central nervous system demyelination. The range is 0-10.0.

    Measured: 10 years from the date of enrollment

  2. modified Rankin Score

    Modified Rankin score is the most commonly used in evaluating the daily life ability of patients with neurological disorders. The range is 0-6.

    Measured: 10 years from the date of enrollment

  3. MMT-8 Score

    MMT-8 Score is mostly used in evaluating muscle strength of patients with myopathy. The range is 0-150.

    Measured: 10 years from the date of enrollment

  4. QMG Score

    An authoritative quantitative scale to assess the disease severity of patients with myasthenia gravis. The range is 0-39.

    Measured: 10 years from the date of enrollment

  5. Annual recurrence rate

    Measured: 10 years from the date of enrollment

  6. Adverse event

    All participants with treatment-related adverse events as will be assessed by CTCAE v4.0.

    Measured: 10 years from the date of enrollment

Secondary outcomes (3)

  1. Quantification of pathogenic antibodies

    Typical pathogenic antibodies include anti-AQP4-IgG, anti-MOG-IgG, anti-GFAP-IgG, anti-NMDAR-IgG, anti-LGI1-IgG, anti-AMPA-IgG, anti-AchR-IgG, anti-MUSK-IgG, etc, which are tested by ELISA in mmol/l.

    Measured: 10 years from the date of enrollment

  2. Quantification of cytokines

    Common cytokines include IL2, IL2R, IL6, IL8, IL10, TNFα, etc.

    Measured: 10 years from the date of enrollment

  3. Quantitative and qualitative analysis of immunocyte subtypes

    Common subtypes include CD3+CD19-,CD3-CD19+,CD3+CD4+,CD3+CD8+,CD3-CD16+CD56+,CD3+CD56+, etc. They are showed in cells/ul.

    Measured: 10 years from the date of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Mar 2036 (estimated)
  4. Study completion1 Mar 2037 (estimated)

Resources

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
Cross-sectional
Enrolment
1,550 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333196
Sponsor's protocol ID
NADsinTJ
Status last verified
Jan 2026
First submitted
9 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and NMO Spectrum Disorder, run by Tongji Hospital 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 47 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Jan 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EDSS Score (time frame: 10 years from the date of enrollment). The study lists 6 primary outcomes in all. 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 NCT07333196.

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 21 Jan 2026.

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Tongji NADs Cohort (NCT07333196) | AzTrials