General Drug Use Surveillance (All Patient Surveillance) of ENSPRYNG Syringes for Subcutaneous Injection - Prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) -

General Drug Use Surveillance (All Patient Surveillance) of ENSPRYNG Syringes for Subcutaneous Injection - Prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) - - General Drug Use Surveillance (All Patient Surveillance) of ENSPRYNG Syringes for Subcutaneous Injection - Prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041047

Enrollment

330

Registered

2020-08-26

Start date

2020-08-26

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 disorder (including neuromyelitis optica)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Neuromyelitis optica spectrum disorder (including neuromyelitis optica)

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1)Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF 2)Patient demographics: Patient initials, age at treatment initiation, ID number, sex, pregnancy, height, body weight, reason for use, details of neuromyelitis optica spectrum disorder (anti-AQP4 antibody, anti-MOG antibody, clinical signs, date of diagnosis, number of relapses within 2 years, expanded disability status scale [EDSS Score]), previous disease, concurrent disease, test of hepatitis B virus (HBs antigen, HBs antibody, HBc antibody), and previous treatment (immunosuppressive agent, other biological product) 3)Treatment status: Enspryng treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation if treatment is discontinued) 4)Administration period of concomitant therapy: Corticosteroid other than steroid pulse therapy (treatment start date, treatment stop date), immunosuppressive agent (treatment start date, treatment stop date) 5)Treatment status of concomitant therapy (at start of treatment, every 6 months): Corticosteroid other than steroid pulse therapy (whether administered, drug name, administration route, daily dose), immunosuppressive agent (whether administered, drug name) 6)Relapse status (whether relapse occurs, date of relapse diagnosis, steroid pulse therapy [whether performed], plasmapheresis [whether performed]) 7)Adverse event: Whether adverse event develops, name of adverse event or abnormal laboratory data, date of occurrence, seriousness, intervention (Enspryng, other), outcome, date of outcome, causal relationship (Enspryng, other factors) For events that are considered to be potentially related to anti-Enspryng antibodies, anti-Enspryng antibodies will be tested as deemed necessary by physicians.	—

Measure

Time frame

1)Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF 2)Patient demographics: Patient initials, age at treatment initiation, ID number, sex, pregnancy, height, body weight, reason for use, details of neuromyelitis optica spectrum disorder (anti-AQP4 antibody, anti-MOG antibody, clinical signs, date of diagnosis, number of relapses within 2 years, expanded disability status scale [EDSS Score]), previous disease, concurrent disease, test of hepatitis B virus (HBs antigen, HBs antibody, HBc antibody), and previous treatment (immunosuppressive agent, other biological product) 3)Treatment status: Enspryng treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation if treatment is discontinued) 4)Administration period of concomitant therapy: Corticosteroid other than steroid pulse therapy (treatment start date, treatment stop date), immunosuppressive agent (treatment start date, treatment stop date) 5)Treatment status of concomitant therapy (at start of treatment, every 6 months): Corticosteroid other than steroid pulse therapy (whether administered, drug name, administration route, daily dose), immunosuppressive agent (whether administered, drug name) 6)Relapse status (whether relapse occurs, date of relapse diagnosis, steroid pulse therapy [whether performed], plasmapheresis [whether performed]) 7)Adverse event: Whether adverse event develops, name of adverse event or abnormal laboratory data*, date of occurrence, seriousness, intervention (Enspryng, other), outcome, date of outcome, causal relationship (Enspryng, other factors) * For events that are considered to be potentially related to anti-Enspryng antibodies, anti-Enspryng antibodies will be tested as deemed necessary by physicians.

—

Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety Science 2 Dept.

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

Outcome results