This study is in progress, not accepting new patients

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

a study on Multiple Sclerosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Emmanuelle WaubantBruce Cree
Headshot of Emmanuelle Waubant
Emmanuelle Waubant
Headshot of Bruce Cree
Bruce Cree

Description

Summary

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

Keywords

Multiple Sclerosis, ocrelizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Concurrent participation in any clinical trial (other than the Parent study)
  • Unable or unwilling to comply with the requirements of the protocol

Locations

  • UCSF
    San Francisco California 94117 United States
  • UCSF
    San Francisco California 94143 United States
  • Stanford Hospital and Clinics
    Palo Alto California 94304 United States

Lead Scientists at UCSF

  • Emmanuelle Waubant
    Dr Waubant trained as a neurologist in Toulouse, France. She continued her training as a neuroimmunology fellow in Dr Stephen Hauser’s UCSF laboratory, focusing on matrix metalloproteinases (MMP) and their tissue inhibitors (TIMP), and their role in migration of lymphocytes through equivalents of the blood-brain barrier.
  • Bruce Cree
    Bruce Cree, MD, PhD, MAS is a Professor of Clinical Neurology and is the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. Dr. Cree completed his MD and PhD in Biochemistry at UCSF. His neurology residency training was at Columbia University.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05269004
Phase
Phase 3 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 1300 study participants
Last Updated