Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database

Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database - Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051151

Enrollment

4000

Registered

2023-06-01

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica spectrum disorders (NMOSD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients who have the earliest NMOSD diagnosis (ICD-10 code G36.0, without suspicious flag) recorded in a certain hospital during the patient selection period (2016-01-01 to 2022-08-31). The index date is the first diagnosis.

Exclusion criteria

Exclusion criteria: The patients who have any record of prescription for the following drugs for the treatment of multiple sclerosis (MS) at any time point: - Interferon beta-1a, - Interferon beta-1b, - Ofatumumab, - Natalizumab, - Glatiramer acetate, - Dimethyl fumarate, - Siponimod fumarate, - Fingolimod hydrochloride.

Design outcomes

Primary

Measure	Time frame
Incidence rate, proportion, frequency, cumulative incidence, cumulative mean count of serious infections	—

Secondary

Measure	Time frame
Hazard ratios of potential risk factors for serious infections	—

Countries

Japan

Contacts

Public ContactShinichi Matsuda

Chugai Pharmaceutical Co., Ltd Risk Communication Dept.

matsudasni@chugai-pharm.co.jp03-3281-6611

Outcome results