Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review

Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review - SAkuraBeyond

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050027

Enrollment

120

Registered

2023-01-13

Start date

2023-03-16

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Have a diagnosis of neuromyelitis optica spectrum disorder (including neuromyelitis optica). 2) Have a diagnosis of AQP4 antibody seropositive prior to satralizumab initiation prior to administration of satralizumab, which can be confirmed in the medical record. 3) Started satralizumab after 26th August 2020 at our study site. 4) 7 years old or older at the start of satralizumab treatment. 5) Registered in the satralizumab post marketing surveillance (all-case survey). 6) Signed informed consent has been obtained from the patient or the legally acceptable representative to participate in the study. For patient aged 7-16 years, signed informed consent in writing if possible. Or, if it is difficult to obtain appropriate consent for reasons such as changing hospital at the time of screening in this study, medical institutions are provided with the opportunity to notify or disclose the use of information to research subjects and refuse it. 7) Satralizumab has been selected as the most appropriate medical care.

Exclusion criteria

Exclusion criteria: Any previous treatment with IL-6 inhibitory therapy except satralizumab.

Design outcomes

Primary

Measure	Time frame
1. Clinical measures related to disease activity through 26 weeks and 130 weeks after the start of treatment with satralizumab - Annualized relapse rate - Time to first relapse - Proportion of relapse-free patients 2. Details of relapse - Position of relapse - Chief complaint of relapse - Visual acuity at the time of relapse - Content of acute treatment - Proportion of hospitalization due to relapse - Length of hospital stay at the time of relapse - Proportion of patients who re-started satralizumab after relapse and time to restart - Types and doses of concomitant medications at relapse - Biologics started after relapse under satralizumab treatment 3. Dose of concomitant medication over time for the patient who had relapse during satralizumab treatment	—

Measure

Time frame

1. Clinical measures related to disease activity through 26 weeks and 130 weeks after the start of treatment with satralizumab - Annualized relapse rate - Time to first relapse - Proportion of relapse-free patients 2. Details of relapse - Position of relapse - Chief complaint of relapse - Visual acuity at the time of relapse - Content of acute treatment - Proportion of hospitalization due to relapse - Length of hospital stay at the time of relapse - Proportion of patients who re-started satralizumab after relapse and time to restart - Types and doses of concomitant medications at relapse - Biologics started after relapse under satralizumab treatment 3. Dose of concomitant medication over time for the patient who had relapse during satralizumab treatment

—

Countries

Japan

Contacts

Public ContactTomoko Kubo

EPS Corporation Clinical Research Center, Real World Evidence Business Headquarters

prj-sakurabeyond@eps.co.jp03-5804-5045

Outcome results