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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05269004

Collaborator

(none)

1,300

Enrollment

Locations

Arm

Anticipated Duration (Months)

46.4

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Ocrelizumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ocrelizumab 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). 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.	Drug: Ocrelizumab Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Arm

Intervention/Treatment

Experimental: Ocrelizumab

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). 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.

Drug: Ocrelizumab

Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 [Up to 44 months]

Secondary Outcome Measures

Change in Expanded Disability Status Scale (EDSS) score over time [Week 0, 24, 48, 72, 96, 120, 168]
Change in 9-Hole Peg Test (9HPT) over time [Week 0, 24, 48, 72, 96, 120, 168]
Change in Timed 25-Foot Walk Test (T25FWT) over time [Week 0, 24, 48, 72, 96, 120, 168]
The number of T1 lesions and number of new or enlarging T2 lesions [Week 0, 24, 48, 72, 96, 120, 168]
The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume [Week 0, 24, 48, 72, 96, 120, 168]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Neurosciences Research LLC	Fort Collins	Colorado	United States	80524
2	Neurology Associates PA	Maitland	Florida	United States	32751
3	Neurological Services of Orlando	Orlando	Florida	United States	32806
4	Kansas University Medical Center	Kansas City	Kansas	United States	66103
5	Rutgers New Jersey Medical School; Department of Neurology	Newark	New Jersey	United States	07103
6	South Shore Neurologic Associates, PC	Patchogue	New York	United States	11772
7	The Neurological Institute PA	Charlotte	North Carolina	United States	28204
8	Raleigh Neurology Associates	Raleigh	North Carolina	United States	27607-6520
9	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
10	Providence Neurological Specialties	Portland	Oregon	United States	97225
11	Abington Neurological Associates	Abington	Pennsylvania	United States	19001
12	Neurology Clinic PC	Cordova	Tennessee	United States	38018
13	Sibyl Wray MD Neurology PC	Knoxville	Tennessee	United States	37934
14	Bhupesh Dihenia M.D. P.A.	Lubbock	Texas	United States	79410
15	Central Texas Neurology Consultants	Round Rock	Texas	United States	78681
16	Neurology Center of San Antonio	San Antonio	Texas	United States	78212
17	Military Medical Academy - MHAT - Sofia; Department of Rheumatology	Sofia		Bulgaria	1606
18	Clinique Neuro Outaouais	Gatineau	Quebec	Canada	J8Y 1W2
19	Hopital Neurologique Pierre Wertheimer	Bron		France	69500
20	CHU Strasbourg - Hôpital Hautepierre	Strasbourg		France	67098
21	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milano	Lombardia	Italy	20133
22	Fondazione Istituto G. Giglio di Cefalu	Cefalù	Sicilia	Italy	90015
23	Pauls Stradins Clinical University Hospital	Rīga		Latvia	LV-1002
24	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Public Institution	Kaunas		Lithuania	50009
25	Klaipeda University Hospital; Public Institution	Klaipeda		Lithuania	92288
26	MUDr. Beata Dupejova Neurologicka ambulancia s.r.o	Banska Bystrica		Slovakia	974 04
27	Hospital Universitario Virgen Macarena	Seville	Sevilla	Spain	41071
28	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT05269004

Other Study ID Numbers:

MN43964
2021-005746-15

First Posted:

Mar 7, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Ocrelizumab

Study Results

No Results Posted as of Aug 25, 2022