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Efficacy and safety of Inelizumab in NMOSDN combined with autoimmune diseases

Efficacy and safety of Inelizumab in NMOSDN combined with autoimmune diseases

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090925
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-10-18
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis spectrum disease

Interventions

Case series:NA

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with NMOSD (Chinese Guidelines for the Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases, 2015 edition) 2) Male/female patients =18 years of age with a diagnosis of NMOSD Blood AQP4-IgG status: Blood AQP4-IgG (+), =1 acute episode requiring emergency treatment in the past 1 year, or =2 acute episodes requiring rescue treatment in the past 2 years 3) Diagnosed autoimmune diseases (Sjogren's syndrome, SLE, undifferentiated connective tissue disease, Hashimoto's disease) Thyroiditis, hypothyroidism) (Chinese Guidelines for Sjogren's Syndrome 2023) (Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus 2023) (Diagnostic criteria for Hashimoto's thyroiditis) (Guidelines for the Diagnosis and Treatment of Chronic hypothyroidism in Adults 2022) 4) NMOSD patients who have been treated with Inebilizumab in the last five years 5) Sign informed consent

Exclusion criteria

Exclusion criteria: 1. Residents or family members are unable to cooperate with the questionnaire content or with the examination and treatment. 2. Patients with severe liver damage, kidney damage, heart failure, severe infection, coagulation function, and immune deficiency syndrome 3. Lactating and pregnant women 4. History of HIV, active hepatitis B or C, active syphilis

Design outcomes

Primary

MeasureTime frame
Annual recurrence rate;

Secondary

MeasureTime frame
Expanded Disability Status Scale score;Number of hospitalizations for NMOSD;The number of active lesions;EULAR Sj?gren's Syndrome Disease Activity Index;Duration and severity score of limb pain before and after medication;

Countries

China

Contacts

Public ContactYanxia Zhou

Shenzhen Second People's Hospital

yanxia.zhou@foxmail.com+86 189 2848 8136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026