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

AstraZeneca

Status: Enrolling

Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD); Rare Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT07247292

D9282R00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults (≥18 years) with a confirmed diagnosis of AQP4-IgG positive NMOSD following the 2015 IPND criteria;
2. Provision of signed and dated written informed consent.

Exclusion criteria

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