Tongji NADs Cohort

NCT07333196 | Not Yet Recruiting

• 1 other identifier: NADsinTJ
• Study Type: observational
• Target: 1,550
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis; NMO Spectrum Disorder; Autoimmune Encephalitis; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Autoimmune Nodopathy; Acute Inflammatory Demyelinating Polyradiculoneuropathy; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Myasthenia Gravis; Idiopathic Inflammatory Myopathies

Outcome Measures

Primary Outcomes (6)

• 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.

  10 years from the date of enrollment

• 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.

  10 years from the date of enrollment

• MMT-8 Score

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

  10 years from the date of enrollment

• QMG Score

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

  10 years from the date of enrollment

• Annual recurrence rate

  10 years from the date of enrollment

• Adverse event

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

  10 years from the date of enrollment

Secondary Outcomes (3)

• Quantification of pathogenic antibodies

  10 years from the date of enrollment

• Quantification of cytokines

  10 years from the date of enrollment

• Quantitative and qualitative analysis of immunocyte subtypes

  10 years from the date of enrollment

Interventions

No active interventions OTHER

The therapies are based on needs of the participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Participants must meet the following eligibility criteria at the time of screening to participate in this study.
• 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.
• Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.
• Must be diagnosed with one of the following conditions:
• This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:
• ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.
• ≥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.
• 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.

You may not qualify if:

• The investigators identified other unexplained factors that may have disqualified participants from enrollment.

Sponsors & Collaborators

• Tongji Hospital: lead
• Shenzhen Genocury Biotech Co., Ltd.: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): March 1, 2037
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)