Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 1:02 AM
Study NCT ID:
NCT05269004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLERO
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-005746-15 | EUDRACT_NUMBER | None | View |