A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis (OLERO)
D
David Mattson, MD
Primary Investigator
Administratively Closed
18 years or above
All
Phase
3
1300 participants needed
1 Location
Brief description of study
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumabvestigational medicinal product (IMP) in a Roche sponsored Parent study who continueve ocrelizumab or are in safety follow-up at the time of the closure of theirve Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in thisudy. Participants who will continue ocrelizumab treatment will receive IMP basedhe dosage and administration received at the time of rollover from the Parent study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Sclerosis
-
Age: 18 years or above
-
Gender: All
Inclusion criteria
- Prior eligibility for and previous participation in 1 of the Roche-sponsored Parentudies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumabvestigational medicinal product (IMP) or being in safety follow-up afterdiscontinuation
- For female participants of childbearing potential: agreement to remain abstinent(refrain from heterosexual intercourse) or use adequate acceptable contraceptionduring the treatment period and for at least 6 months or longer if the local label isgent after the final dose of ocrelizumab, as applicable in the ocrelizumabkage 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
Updated on
13 Dec 2024.
Study ID: MN43964, NEUR-GENENTECH-OLERO, 14972
