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A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Not Recruiting
Trial ID: NCT05269004
Purpose
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab
as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue
to receive ocrelizumab or are in safety follow-up at the time of the closure of their
respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this
extension study. Participants who will continue ocrelizumab treatment will receive IMP based
on the dosage and administration received at the time of rollover from the Parent study.
Official Title
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
Stanford Investigator(s)
Jeffrey Dunn, MD
Clinical Professor, Neurology & Neurological Sciences
Eligibility
Inclusion criteria
- Prior eligibility for and previous participation in 1 of the Roche-sponsored 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
- Concurrent participation in any clinical trial (other than the Parent study)
- Unable or unwilling to comply with the requirements of the protocol
Intervention(s):
drug: Ocrelizumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
SPECTRUM
6507364310