Neuromyelitis Optica Spectrum Disorder (NMOSD)NCT07032337
Efficacy and Safety of Conventional Immunosuppressant Therapies in Elderly Patients With Neuromyelitis Optica Spectrum Disorder
An observational study of Neuromyelitis Optica Spectrum Disorder (NMOSD), run by Samsung Medical Center.
Trial summary
Newly diagnosed NMOSD patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
- How many people
- 2,985 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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)
Who may be able to join
- From 2011 to 2022, newly diagnosed NMOSD patients..
Who cannot join
- Patients had a history of cancer
- Patients had used ISTs (excluding steroids) prior to the NMOSD diagnosis.
About this study
Official title: Efficacy and Safety of Conventional Immunosuppressant Therapies in Elderly Patients With Neuromyelitis Optica Spectrum Disorder: A Target Trial Emulation Study
Newly diagnosed NMOSD patients
Read the 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.
- Keywords
- immunosuppressive therapies, azathioprine, mycophenolate mofetil, rituximab, elderly
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IST group | patients who initiated any ISTs | |
| non-IST group | patients who did not initiate any ISTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Relapses were identified when patients were treated with one of the following interventions: intravenous steroids, immunoglobulin therapy, or plasma exchange.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 6 months after start of ISTs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2025
- Study start1 Jan 2011
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorder (NMOSD)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju-Hong Min, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032337
- Sponsor's protocol ID
- IST_NMOSD
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2025
- Last updated
- 23 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Conventional Immunosuppressant Therapies in Elderly Patients With Neuromyelitis Optica Spectrum Disorder: A Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07032337
- Acronym / sponsor ID
- IST_NMOSD
- Keywords
- immunosuppressive therapies, azathioprine, mycophenolate mofetil, rituximab, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,985 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IST group | – | –patients who initiated any ISTs |
| non-IST group | – | –patients who did not initiate any ISTs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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)
Key inclusion criteria (1 listed)
- From 2011 to 2022, newly diagnosed NMOSD patients..
Key exclusion criteria (2 listed)
- Patients had a history of cancer
- Patients had used ISTs (excluding steroids) prior to the NMOSD diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse
Time frame: 1 year
Relapses were identified when patients were treated with one of the following interventions: intravenous steroids, immunoglobulin therapy, or plasma exchange.
1 secondary outcome
Safety outcomes
Time frame: 6 months after start of ISTs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorder (NMOSD), run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2025.