An observational study in Rare Diseases and Neuromyelitis Optica Spectrum Disorder (NMOSD), sponsored by AstraZeneca. Terminated at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by AstraZeneca · Observational
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.
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.
203 studies on the registry are indexed under Rare Diseases; 112 are open to participants now.
This study's enrollment of 3 is below the median of 200 across 125 observational studies indexed under Rare Diseases.
Browse Rare Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
1.Participants currently enrolled in clinical studies for the treatment of NMOSD.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From NMOSD diagnosis to inclusion and Months 6, 12, 18, 24, 30, and 36 post-inclusion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From inclusion (T0) to first relapse event, up to Month 36 (T6)
Plan to share: 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
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca