Rare DiseasesNCT07247292
Epidemiological Study of Treatment Approaches on AQP4-IgG Positive NMOSD in Russia
An observational study of Rare Diseases and Neuromyelitis Optica Spectrum Disorder (NMOSD), run by AstraZeneca at 1 site in Russia.
Trial summary
This is a multi-centre, retrospective-prospective, single-arm, non-interventional (observational) cohort study with secondary data collection within real-world settings of participants with AQP4-IgG positive NMOSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rare Diseases, Neuromyelitis Optica Spectrum Disorder (NMOSD)
- How many people
- 3 participants
- Where
- 1 siteRussia
- Study dates
- 23 Dec 2025to 26 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of both sexes aged 18 years and older with diagnosis of AQP4-IgG positive NMOSD established according to 2015 IPND criteria will be enrolled in various clinical institutions in Russia that provide treatment for NMOSD patients.
Who may be able to join
- Adults (≥18 years) with a confirmed diagnosis of AQP4-IgG positive NMOSD following the 2015 IPND criteria;
- Provision of signed and dated written informed consent.
Who cannot join
- 1.Participants currently enrolled in clinical studies for the treatment of NMOSD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Non-interventional Single-arm Retrospective-prospective Observational Study in Therapeutic Approaches on AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) in Real Clinical Practice in Russia
This is a multi-centre, retrospective-prospective, single-arm, non-interventional (observational) cohort study with secondary data collection within real-world settings of participants with AQP4-IgG positive NMOSD.
Read the detailed description
This is a multicenter, retrospective-prospective, single-arm observational cohort study using secondary data collection from routine care medical records.
The primary objective is to describe baseline demographic and clinical characteristics, diagnostic algorithms, and treatment approaches. Secondary objectives are to describe Expanded Disability Status Scale (EDSS) levels and dynamics, collect the rate, duration, and reasons for hospitalizations, and evaluate physician-reported relapse profiles.
Approximately 100 adults will be enrolled consecutively across about 10 specialized sites. The study will sequentially include only those patients who have signed the informed consent form (ICF). Eligible patients will be enrolled consecutively at each site to minimize selection bias. Each participant will be followed for 36 months from informed consent (T0), with data collection every 6 months (T1-T6). The baseline period is defined as the time from NMOSD diagnosis until inclusion, with retrospective data abstraction; subsequent data are collected prospectively at routine visits. All data are entered into an electronic case report form (eCRF) from paper/electronic medical records. No study-specific interventions are performed; treatment is determined by usual care.
- Medical subject headings
- Rare Diseases, Neuromyelitis Optica
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographics and clinical characteristics
Summary of participant demographics and clinical history at inclusion: age at inclusion and at NMOSD diagnosis, sex, ethnicity, BMI at inclusion, disease duration, clinical symptoms at inclusion, comorbidities.
Measured: At inclusion
Pre-inclusion relapse history
Proportion of patients with ≥1 and >1 physician-reported relapses and severe relapses (EDSS increase ≥2.0 points from baseline per event); annualized relapse rate (ARR) prior to inclusion.
Measured: From NMOSD diagnosis to inclusion (retrospective baseline)
Pre-inclusion NMOSD-related hospitalizations
Number of patients with NMOSD-related hospitalizations from the time of NMOSD diagnosis; median cumulative duration (days) of NMOSD-related hospitalizations prior to inclusion.
Measured: From NMOSD diagnosis to inclusion (retrospective baseline)
Time from first symptoms to NMOSD diagnosis
Median time (months) from patient-reported first NMOSD symptoms to confirmed NMOSD diagnosis according to 2015 IPND criteria.
Measured: From first NMOSD symptoms to date of diagnosis (retrospective baseline)
Prior misdiagnoses profile
Proportion of patients with any prior misdiagnosis and by type (e.g., MS, MOGAD, CNS infections, SLE only, Sjögren's only, Behçet's, neurosarcoidosis, CNS vascular disease, toxic/metabolic, neoplasms/paraneoplastic, congenital CNS, other).
Measured: From first NMOSD symptoms to confirmed NMOSD diagnosis (retrospective baseline)
AQP4-IgG testing method
Number and proportion of patients tested by cell-based assay versus ELISA for AQP4-IgG serostatus determination.
Measured: At time of NMOSD diagnostic workup (retrospective baseline)
MRI brain T2-hyperintense lesion count change
Mean change from baseline in the number of T2-hyperintense brain lesions; presence of T1 contrast-enhancing lesions recorded as categorical variables.
Measured: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Optic nerve MRI findings
Presence of contiguous lesions, bilateral neuritis, chiasmal extension, and optic nerve atrophy recorded as categorical variables per timepoint.
Measured: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Spinal cord MRI lesion metrics
T2 lesion count; presence of longitudinally extensive lesions (≥3 segments), transverse lesions, and spinal cord atrophy extending ≥3 segments recorded as categorical variables per timepoint.
Measured: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Relapse prevention therapy patterns
Number of patients receiving relapse prevention therapy by regimen: immunosuppressive drugs monotherapy; biologic monotherapy; biologic plus immunosuppressive combination; mean daily corticosteroid dose if low-dose steroids used (prednisolone-equivalent).
Measured: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Acute relapse treatment modalities
Number of patients receiving high-dose corticosteroids, plasma exchange, or immunoadsorption for acute relapses; summarized per period.
Measured: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Concomitant medications
Number of patients by class/type of concomitant medications for comorbid conditions recorded from diagnosis to inclusion and prospectively.
Measured: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Secondary outcomes (10)
EDSS mean at each time point
Expanded Disability Status Scale (EDSS) mean score across participants at each scheduled assessment; EDSS assessed per routine clinical practice.
Measured: Baseline (T0) and Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)
EDSS mean change from baseline
Mean change in EDSS from baseline (T0) to each follow-up time point; change calculated as EDSS at time point minus baseline EDSS.
Measured: Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)
All-cause hospitalizations
Number of patients with ≥1 hospitalization from any cause during follow-up; counts summarized overall and by hospitalization cause categories.
Measured: From inclusion (T0) through Month 36 (T6)
Median cumulative duration of hospitalizations
Median cumulative number of days spent hospitalized per patient during follow-up; calculated across all hospitalizations per participant.
Measured: From inclusion (T0) through Month 36 (T6)
NMOSD-related hospitalizations
Number of patients with ≥1 hospitalization due to NMOSD during follow-up; NMOSD-related as documented in medical records.
Measured: From inclusion (T0) through Month 36 (T6)
Median cumulative duration of NMOSD-related hospitalizations
Median cumulative number of days spent hospitalized per patient for NMOSD-related causes during follow-up.
Measured: From inclusion (T0) through Month 36 (T6)
Patients with physician-reported relapse(s)
Number of patients with ≥1 and >1 physician-reported NMOSD relapse during follow-up; relapses defined per protocol and documented by clinician assessment.
Measured: From inclusion (T0) through Month 36 (T6)
Patients with severe relapse(s)
Number of patients with ≥1 and >1 severe NMOSD relapse during follow-up; severe relapse defined as EDSS increase ≥2.0 points from baseline (for myelitis) or major OSIS exacerbation, per protocol.
Measured: From inclusion (T0) through Month 36 (T6)
Annualized relapse rate (ARR)
ARR calculated as total number of physician-reported relapses divided by person-years observed during follow-up for each patient, summarized at the cohort level.
Measured: From inclusion (T0) through Month 36 (T6)
Median time to first physician-reported relapse
Time from inclusion (T0) to first physician-reported NMOSD relapse; analyzed using Kaplan-Meier methods with censoring at Month 36 or withdrawal.
Measured: From inclusion (T0) to first relapse event, up to Month 36 (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start23 Dec 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Why it stopped: The decision is based on strategic deprioritization and is not related to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Other
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247292
- Sponsor's protocol ID
- D9282R00001
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Non-interventional Single-arm Retrospective-prospective Observational Study in Therapeutic Approaches on AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) in Real Clinical Practice in Russia
- ClinicalTrials.gov ID
- NCT07247292
- Acronym / sponsor ID
- D9282R00001
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The decision is based on strategic deprioritization and is not related to any safety concerns.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 25 Nov 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.
This is a multi-centre, retrospective-prospective, single-arm, non-interventional (observational) cohort study with secondary data collection within real-world settings of participants with AQP4-IgG positive NMOSD.
Detailed description
This is a multicenter, retrospective-prospective, single-arm observational cohort study using secondary data collection from routine care medical records.
The primary objective is to describe baseline demographic and clinical characteristics, diagnostic algorithms, and treatment approaches. Secondary objectives are to describe Expanded Disability Status Scale (EDSS) levels and dynamics, collect the rate, duration, and reasons for hospitalizations, and evaluate physician-reported relapse profiles.
Approximately 100 adults will be enrolled consecutively across about 10 specialized sites. The study will sequentially include only those patients who have signed the informed consent form (ICF). Eligible patients will be enrolled consecutively at each site to minimize selection bias. Each participant will be followed for 36 months from informed consent (T0), with data collection every 6 months (T1-T6). The baseline period is defined as the time from NMOSD diagnosis until inclusion, with retrospective data abstraction; subsequent data are collected prospectively at routine visits. All data are entered into an electronic case report form (eCRF) from paper/electronic medical records. No study-specific interventions are performed; treatment is determined by usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of both sexes aged 18 years and older with diagnosis of AQP4-IgG positive NMOSD established according to 2015 IPND criteria will be enrolled in various clinical institutions in Russia that provide treatment for NMOSD patients.
Key inclusion criteria (2 listed)
- Adults (≥18 years) with a confirmed diagnosis of AQP4-IgG positive NMOSD following the 2015 IPND criteria;
- Provision of signed and dated written informed consent.
Key exclusion criteria (1 listed)
- 1.Participants currently enrolled in clinical studies for the treatment of NMOSD.
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
Baseline demographics and clinical characteristics
Time frame: At inclusion
Summary of participant demographics and clinical history at inclusion: age at inclusion and at NMOSD diagnosis, sex, ethnicity, BMI at inclusion, disease duration, clinical symptoms at inclusion, comorbidities.
Pre-inclusion relapse history
Time frame: From NMOSD diagnosis to inclusion (retrospective baseline)
Proportion of patients with ≥1 and >1 physician-reported relapses and severe relapses (EDSS increase ≥2.0 points from baseline per event); annualized relapse rate (ARR) prior to inclusion.
Pre-inclusion NMOSD-related hospitalizations
Time frame: From NMOSD diagnosis to inclusion (retrospective baseline)
Number of patients with NMOSD-related hospitalizations from the time of NMOSD diagnosis; median cumulative duration (days) of NMOSD-related hospitalizations prior to inclusion.
Time from first symptoms to NMOSD diagnosis
Time frame: From first NMOSD symptoms to date of diagnosis (retrospective baseline)
Median time (months) from patient-reported first NMOSD symptoms to confirmed NMOSD diagnosis according to 2015 IPND criteria.
Prior misdiagnoses profile
Time frame: From first NMOSD symptoms to confirmed NMOSD diagnosis (retrospective baseline)
Proportion of patients with any prior misdiagnosis and by type (e.g., MS, MOGAD, CNS infections, SLE only, Sjögren's only, Behçet's, neurosarcoidosis, CNS vascular disease, toxic/metabolic, neoplasms/paraneoplastic, congenital CNS, other).
AQP4-IgG testing method
Time frame: At time of NMOSD diagnostic workup (retrospective baseline)
Number and proportion of patients tested by cell-based assay versus ELISA for AQP4-IgG serostatus determination.
MRI brain T2-hyperintense lesion count change
Time frame: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Mean change from baseline in the number of T2-hyperintense brain lesions; presence of T1 contrast-enhancing lesions recorded as categorical variables.
Optic nerve MRI findings
Time frame: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Presence of contiguous lesions, bilateral neuritis, chiasmal extension, and optic nerve atrophy recorded as categorical variables per timepoint.
Spinal cord MRI lesion metrics
Time frame: Baseline (≤12 months pre-inclusion) and Months 6, 12, 18, 24, 30, and 36 post-inclusion
T2 lesion count; presence of longitudinally extensive lesions (≥3 segments), transverse lesions, and spinal cord atrophy extending ≥3 segments recorded as categorical variables per timepoint.
Relapse prevention therapy patterns
Time frame: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Number of patients receiving relapse prevention therapy by regimen: immunosuppressive drugs monotherapy; biologic monotherapy; biologic plus immunosuppressive combination; mean daily corticosteroid dose if low-dose steroids used (prednisolone-equivalent).
Acute relapse treatment modalities
Time frame: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Number of patients receiving high-dose corticosteroids, plasma exchange, or immunoadsorption for acute relapses; summarized per period.
Concomitant medications
Time frame: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
Number of patients by class/type of concomitant medications for comorbid conditions recorded from diagnosis to inclusion and prospectively.
10 secondary outcomes
EDSS mean at each time point
Time frame: Baseline (T0) and Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)
EDSS mean change from baseline
Time frame: Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)
All-cause hospitalizations
Time frame: From inclusion (T0) through Month 36 (T6)
Median cumulative duration of hospitalizations
Time frame: From inclusion (T0) through Month 36 (T6)
NMOSD-related hospitalizations
Time frame: From inclusion (T0) through Month 36 (T6)
Median cumulative duration of NMOSD-related hospitalizations
Time frame: From inclusion (T0) through Month 36 (T6)
Patients with physician-reported relapse(s)
Time frame: From inclusion (T0) through Month 36 (T6)
Patients with severe relapse(s)
Time frame: From inclusion (T0) through Month 36 (T6)
Annualized relapse rate (ARR)
Time frame: From inclusion (T0) through Month 36 (T6)
Median time to first physician-reported relapse
Time frame: From inclusion (T0) to first relapse event, up to Month 36 (T6)
Results and safety
The study was stopped early (reason given: The decision is based on strategic deprioritization and is not related to any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Diseases and Neuromyelitis Optica Spectrum Disorder (NMOSD), run by AstraZeneca at 1 site in Russia.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: The decision is based on strategic deprioritization and is not related to any safety concerns.). Results are not available in the source record.
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?
Baseline demographics and clinical characteristics (time frame: At inclusion). The study lists 12 primary outcomes in all. 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 21 Jul 2026.