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A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523726-40-00
Enrollment
36
Registered
2026-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-26

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

Conditions

Multiple Sclerosis

Brief summary

Occurrence of successful self/lay caregiver administration of the Week 1 dose

Detailed description

Occurrence of successful self/lay caregiver administration at home of the Week 24 and Week 48 doses, Occurrence and nature of injection reactions (severity, treatment, need for intervention by a healthcare professional, outcome), Occurrence and severity of adverse device effect (ADEs) and anticipated serious adverse device effect (ASADEs), Occurrence of unanticipated serious adverse device effect (USADEs), Occurrence of device deficiency (DDs) that could lead to serious adverse device effect serious adverse device effect (SADEs)

Interventions

DRUGOcrevus
DRUGOcrelizumab

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Occurrence of successful self/lay caregiver administration of the Week 1 dose—

Secondary

MeasureTime frame
Occurrence of successful self/lay caregiver administration at home of the Week 24 and Week 48 doses, Occurrence and nature of injection reactions (severity, treatment, need for intervention by a healthcare professional, outcome), Occurrence and severity of adverse device effect (ADEs) and anticipated serious adverse device effect (ASADEs), Occurrence of unanticipated serious adverse device effect (USADEs), Occurrence of device deficiency (DDs) that could lead to serious adverse device effect serious adverse device effect (SADEs)—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 27, 2026