Epidemiological Study of Treatment Approaches on AQP4-IgG Positive NMOSD in Russia

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.

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

Conditions

Rare Diseases, Neuromyelitis Optica Spectrum Disorder (NMOSD)

Medical subject headings

Rare Diseases, Neuromyelitis Optica

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Nov 2025
2. Study start23 Dec 2025
3. Primary completion26 Feb 2026
4. 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.