Switch Study of Ravlizumab

Study of the patients who have suboptimal response with Satralizumab and switched to Ravulizumab - Real World effectiveness and safety of Ravulizumab

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCTs031230647

Enrollment

Registered

2024-02-21

Start date

2024-03-05

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 neuromyelitis optica spectrum disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Men and women of 18 years of age or more at the time of obtaining consent 2)Patients diagnosed with AQP4+ NMOSD 3)Patients on treatment with satralizumab for at least 3 months who wish to switch treatment to ravulizumab based on the judgment of physicians and patients that clinical improvement with satralizumab is suboptimal. 4)Patients with MRI images of head and spine within the past year and being treated with satralizumab 5)Patients who can complete the QOL questionnaire by themselves (If the patient has visual impairment or if the dexterity of the dominant hand is lost, writing for somebody is allowed.) 6)Patients within 3 months from stopping satralizumab treatment. 7)Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients treated with satralizumab for < 3 months Patients previously treated with eculizumab or ravulizumab and discontinued due to safety or effectiveness concerns Patients with meningococcal infection Patients participating in other interventional clinical studies Patients who are pregnant or of childbearing potential, who intend to become pregnant, or who are lactating Other patients judged by the study doctor to be inappropriate for participation in the study

Design outcomes

Primary

Measure	Time frame
Proportion of patients who are relapse-free within 12 months of starting ravulizumab	—

Secondary

Measure	Time frame
Proportion of patients whose oral corticosteroid dose was reduced to 5 mg or below 5mg prednisolone-equivalent at 12 months after the start of ravulizumab 2) In patients with a dose equivalent to 5 mg or below 5mg prednisolone-equivalent corticosteroid at enrollment, percentage of patients who were able to reduce the dose of oral immunosuppressants to 50% or below 50% of dose at enrollment at 12 months after the start of ravulizumab 3)New lesions on spine and head MRI, extent of brain atrophy 4)Change in EDSS 5)Changes in PROs: Pain (BPI), fatigue (FACIT), QOL (EQ-5D-5 L) 6)Biomarker Changes	—

Measure

Time frame

Proportion of patients whose oral corticosteroid dose was reduced to 5 mg or below 5mg prednisolone-equivalent at 12 months after the start of ravulizumab 2) In patients with a dose equivalent to 5 mg or below 5mg prednisolone-equivalent corticosteroid at enrollment, percentage of patients who were able to reduce the dose of oral immunosuppressants to 50% or below 50% of dose at enrollment at 12 months after the start of ravulizumab 3)New lesions on spine and head MRI, extent of brain atrophy 4)Change in EDSS 5)Changes in PROs: Pain (BPI), fatigue (FACIT), QOL (EQ-5D-5 L) 6)Biomarker Changes

—

Contacts

Public ContactWakiro Sato

National Center of Neurology and Psychiatry

satow@ncnp.go.jp+81-42-341-2711

Outcome results