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

NCT07032337 | Completed

• 1 other identifier: IST_NMOSD
• Study Type: observational
• Target: 2,985
• Locations: 0 countries
• Sites: N/A

Brief Summary

Newly diagnosed NMOSD patients

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Keywords

immunosuppressive therapies; azathioprine; mycophenolate mofetil; rituximab; elderly

Outcome Measures

Primary Outcomes (1)

• Relapse

  Relapses were identified when patients were treated with one of the following interventions: intravenous steroids, immunoglobulin therapy, or plasma exchange.

  1 year

Secondary Outcomes (1)

• Safety outcomes

  6 months after start of ISTs

Study Arms (2)

IST group

patients who initiated any ISTs

non-IST group

patients who did not initiate any ISTs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Once diagnosed, patients were eligible to enter weekly emulated trials starting from the diagnosis date. At the beginning of each week (baseline of each emulated trial), eligibility was reassessed: patients who developed cancer or had previously initiated ISTs been excluded from the trial. Eligible patients were then assigned to the IST group if they initiated ISTs within the following 7 days, and to the non-IST group otherwise. Importantly, patients were allowed to contribute to multiple trials over time but could only be assigned to the IST group once-at the time they first initiated ISTs. The first day of follow-up (day zero) for each emulated trial was defined as the final day of that trial's enrollment week, and patients were followed until death or the end of the study period (December 31, 2022)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: June 23, 2025
• Study Start: January 1, 2011
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share