Switch Study of Ravlizumab

JRCT ID: jRCTs031230647

Registered date:21/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: neuromyelitis optica spectrum disorder
• Date of first enrollment: 21/02/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Proportion of patients who are relapse-free within 12 months of starting ravulizumab

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Yamamura Takashi
• Secondary Sponsor: Mitsutake Asako,Alexion Pharma GK