A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

Phase 3

Recruiting

• Conditions: Auto-immune disease; demyelinating disease; 10007951

• Registration Number: NL-OMON55946
• Lead Sponsor: F. Hoffman-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

• Prior eligibility for and previous participation in 1 of the Rochesponsored
Parent Studies WA21092, WA21093, or WA25046 with the participant either
receiving ocrelizumab as an investigational medicinal product (IMP) or being in
safety follow-up after treatment discontinuation
• For female participants of childbearing potential: agreement to remain
abstinent (refrain from heterosexual intercourse) or use adequate acceptable
contraception during the treatment period and for at least 6 months or longer
if the local label is more stringent after the final dose of ocrelizumab, as
applicable in the ocrelizumab package leaflet

Exclusion Criteria

Potential participants are excluded from the study if any of the following
criteria apply:
• Concurrent participation in any clinical trial (other than the Parent study)
• Unable or unwilling to comply with the requirements of the protocol

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified