NCT07333196

Tongji NADs Cohort

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,550 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	No active interventions	The therapies are based on needs of the participants

Timeline

• Start date: 2026-03-01
• Primary completion: 2036-03-01
• Completion: 2037-03-01
• First posted: 2026-01-12
• Last updated: 2026-01-21

Locations

1 site across 1 country: China