Inelizumab in Neuromyelitis optica Spectrum Disease With Primary Sjögren's Syndrome - A Single-center, Two-arm, Real-world Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500111123

Enrollment

Unknown

Registered

2025-10-27

Start date

2025-10-31

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

neuromyelitis optica spectrum disorder (NMOSD)

Interventions

Conventional immunosuppressant treatment group:None

Inebilizumab treatment group:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Aged 18-75 years; 3. No limit to gender; 4. Patients with NMOSD combined with pSS were diagnosed according to the 2021 Chinese Neuromyelitis Optica Spectrum Disease Diagnosis and Treatment Guidelines and the 2016 American College of Rheumatology and European League Against Rheumatism classification criteria. 5. Patients who need to be treated with inelizumab according to the judgment of the treating doctor. 6. Patients must have all of the following data to be included in this study: baseline Expanded Disability Status Scale (EDSS) score less than 8.0 points; baseline AQP4-IgG positivity.

Exclusion criteria

Exclusion criteria: 1. There is a progressive neurological disorder unrelated to NMOSD. 2. Active hepatitis or severe liver insufficiency (more than 2 times the normal value of liver function test), patients with active viral hepatitis. 3. Severe renal insufficiency; 4. Patients with active or untreated latent tuberculosis. 5. Patients with a history of splenectomy, radiation therapy (total body radiation or lymphatic irradiation), or stem cell transplantation. 6. Cancer patients and patients with severe chronic infections or a history of recurrent infections; 7. Other patients who are deemed by the investigators to be unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Relapse or not after enrollment;	—

Secondary

Measure	Time frame
Serum AQP4 Antibody Titers;Expanded Disability Status Scale, EDSS;European League Against Rheumatism Sj?gren's Syndrome Disease Activity Index, ESSDAI;	—

Countries

China

Contacts

Public ContactYuan Chao

Nafang Hospital, Southern Medical University

yuanchao613@163.com+86 20 6164 1888

Outcome results

None listed

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