Efficacy and Safety of Conventional Immunosuppressant The... | NCT07032337

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

NCT07032337

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jun 23, 2025Actual

Enrollment

2,985Actual

Phase

Not provided

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Apr 24, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,985Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IST group		patients who initiated any ISTs
non-IST group		patients who did not initiate any ISTs

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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)

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009471	Neuromyelitis Optica

Ancestor Terms

ID	Term
D009188	Myelitis, Transverse
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided