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

NCT07247292 | Suspended

• 1 other identifier: D9282R00001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rare Diseases; Neuromyelitis Optica Spectrum Disorder (NMOSD)

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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

  Baseline (T0) and Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)

• EDSS mean change from baseline

  Months 6 (T1), 12 (T2), 18 (T3), 24 (T4), 30 (T5), 36 (T6)

• All-cause hospitalizations

  From inclusion (T0) through Month 36 (T6)

• Median cumulative duration of hospitalizations

  From inclusion (T0) through Month 36 (T6)

• NMOSD-related hospitalizations

  From inclusion (T0) through Month 36 (T6)

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Participants currently enrolled in clinical studies for the treatment of NMOSD.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Rare Diseases; Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (1)