NCT07333196

Tongji NADs Cohort

Not yet recruiting Last updated 21 January 2026

What this trial tests

trial testing No active interventions in Multiple Sclerosis in 1,550 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 March 2036

1 March 2037

Quick facts

Lead sponsor	Tongji Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	1,550
Start date	1 March 2026
Primary completion	1 March 2036
Estimated completion	1 March 2037
Sites	1 location across China

Drugs / interventions tested

• No active interventions

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• NMO Spectrum Disorder — all drugs for NMO Spectrum Disorder →
• Autoimmune Encephalitis — all drugs for Autoimmune Encephalitis →
• Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease — all drugs for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease →

Sponsor

Tongji Hospital

Who can join

Adults 18 to 80, any sex, with Multiple Sclerosis or NMO Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.