Efficacy and Safety of Conventional Immunosuppressant Therapies in Elderly Patients With Neuromyelitis Optica Spectrum Disorder

Completed

• Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Registration Number: NCT07032337
• Lead Sponsor: Samsung Medical Center

Brief Summary

Newly diagnosed NMOSD patients

Detailed Description

From 2011 to 2022, newly diagnosed NMOSD patients who had not previously claimed NMOSD. Exclusion criteria were history of cancer or had used ISTs (excluding steroids) prior to the NMOSD diagnosis.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2025-04-24
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-23
• Last Update Posted: 2025-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2985

Inclusion Criteria

• From 2011 to 2022, newly diagnosed NMOSD patients..

Exclusion Criteria

• Patients had a history of cancer
• Patients had used ISTs (excluding steroids) prior to the NMOSD diagnosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse	1 year	Relapses were identified when patients were treated with one of the following interventions: intravenous steroids, immunoglobulin therapy, or plasma exchange.

Secondary Outcome Measures

Name	Time	Method
Safety outcomes	6 months after start of ISTs	Incidence of serious infection, fracture, cancer, myocardial infarction, stroke, depression, anxiety, dementia, and Parkinson's disease which defined as presence of ICD-10 codes.