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

Primary Purpose

Multiple Sclerosis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ocrelizumab

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Barrow Neurological Institute
Arizona Neuroscience Research LLC
MS Center of California
Collaborative Neuroscience Research, LLC
Stanford Hospital and Clinics
University of California San Francisco
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Advanced Neurosciences Research LLC
University of Miami
Neurological Services of Orlando
University of South Florida
Vero Beach Neurology and Research Institute
Atlanta Neuroscience Institute
Northwestern University
Consultants in Neurology Ltd
Indiana Univ School of Med
Kansas University Medical Center
Massachusetts General Hospital
Wayne State University
Henry Ford Hospital
Michigan Institute for Neurological Disorders
Minneapolis Clinic of Neurology
University of Minnesota; Clin. Neuro Research Unit
Washington University
University of Nebraska Medical Center
Rutgers New Jersey Medical School Department of Neurology
Holy Name Hospital
University of New Mexico
South Shore Neurologic Associates PC
SUNY at Stony Brook
The Neurological Institute PA
Atrium Health
OnSite Clinical Solutions LLC
Neurology Associates PA
Raleigh Neurology Associates
University Neurology Inc.
Columbus Neuroscience
Oklahoma Medical Research Foundation
Providence Neurological Specialties
Abington Neurological Associates
Rhode Island Hospital
Neurology Clinic PC
Sibyl Wray MD Neurology PC
Baylor College of Medicine
Uni of Texas Health Science Center At Houston
Bhupesh Dihenia M.D. P.A.
Central Texas Neurology Consultants
Neurology Center of San Antonio
University of Vermont Medical Center; Neurology
Swedish Neuroscience Institute
MultiCare Health System Institute for Research and Innovation
Hospital Español
Fundacion Rosarina de Neurorehabilitacion
Royal North Shore Hospital
St Vincent's Hospital Melbourne
Medizinische Universität Innsbruck
Barmherzige Brueder Konventspital
AKH - Medizinische Universität Wien; Neurology
Grodno University Hospital
Vitebsk Regional Clinical Hospital
State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology
AZ Sint Jan
Cliniques Universitaires Saint-Luc
UZA
AZ Delta Campus Westlaan
Sijsele ALMA Elisabeth ziekenhuis
Clinica Neurológica e Neurocirúrgica de Joinville
HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro
IMV Pesquisa Neurologica Sociedade Simples Ltda
Hospital Universitario Gaffree e Guinle; Neurologia
Hospital Sao Lucas da PUCRS*X
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
MHAT Avis Medica OOD Department of Neurology
MHATNP Sveti Naum EAD
University First MHAT-Sofia St. Joan Krastitel EAD
National Heart Hospital EAD
Acibadem City Clinic Tokuda Hospital Ead
Military Medical Academy MHAT Sofia Department of Rheumatology; Department of Rheumatology
Calgary MS Clinic
University of Alberta; Northern Alberta Trials & Research Centre
UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials
The Ottawa Hospital - General Campus
St Michael Hospital; Hematology and Oncology
Clinique Neuro Outaouais
Recherche Sepmus Inc.
Montreal Neurological Institute and Hospital; Pharmacy Department
General Hospital Varazdin
University Hospital Center Zagreb
Fakultni nemocnice Brno
Fakultni nemocnice u sv. Anny v Brne
Neurospol s.r.o.
Fakultni nemocnice Hradec Kralove
Nemocnice Jihlava
Pardubicka krajska nemocnice a.s.
Vseobecna fakultni nemocnice v Praze
Krajska zdravotni a.s. - Nemocnice Teplice o.z.
West Tallinn Central Hospital
Tartu University Hospital
Tammer Tutka Oy
Groupe Hospitalier Pellegrin
Hopital Neurologique Pierre Wertheimer
CHU de Caen Hopital Cote de Nacre
CHU Hopital Gabriel Montpied
Hopital Roger Salengro Service de Neurologie
CHU Nancy Hôpital Central
CHU Nantes Hopital Nord Laënnec; Pharmacy
CHU Nice - Hôpital Pasteur 2
Centre Hospitalier Intercommunal de Poissy
CHU Strasbourg Hôpital Hautepierre
Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie; Klinik für Neurologie
Charité Universitaetsmedizin Berlin - Campus Ch
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Neurologie in Bonn
Universitaetsklinikum Carl Gustav Carus TU Dresden
Universitaetsklinikum Duesseldorf
Zentrum fuer ambulante Neurologie
Klinikum der Johann Wolfgang Goethe-Universitaet
Universitaetsklinikum Giessen und Marburg GmbH; Zytostatikaabteilung
Universitaetsklinikum Leipzig
Pharmakologisches Studienzentrum
Universitaetsklinikum Muenster
Klinikum rechts der Isar der TU Muenchen
Neurozentrum Prien
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH
Universitaetsklinikum Tuebingen
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
Universitätsklinikum Ulm; Klinik für Neurologie
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
S-Medicon Egeszsegugyi Szolgaltato Kft.
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
Pecsi Tudomanyegyetem
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Hadassah University Hospital - Ein Kerem
Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
Chaim Sheba Medical Center
Chaim Sheba Medical Center; Neurology Department
Tel Aviv Sourasky Medical Center; Department of Neurology
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
Ospedale Policlinico San Martino
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Hospital San Raffaele
Fondazione IRCCS Istituto Neurologico Carlo Besta
Azienda Ospedaliero Universitaria Ospedali Riuniti
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Ospedale degli Infermi
Fondazione Istituto G. Giglio di Cefalu
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
Pauls Stradins Clinical University Hospital
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
Klaipeda University Hospital Public Institution
Vilnius University Hospital Santaros Klinikos
Mexico Centre for Clinical Research
Grupo Medico Camino
Hospital Mexico Americano
Clinical Research Institute
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Centro de Estudios Clinicos y Especialidades Medicas S C
Hospital Angeles Culiacan
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Aguascalientes
Hospital Angeles Chihuahua
Zuyderland Medisch Centrum - Sittard-Geleen'
Waikato Hospital
Haukeland Universitetssykehus
NZOZ Vitamed
COPERNICUS Podmiot Leczniczy Sp z o o
M.A. LEK A.M.Maciejowscy SC.
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Neuro-Medic Janusz Zbrojkiewicz
Centrum Neurologii Klinicznej
Centrum Neurologii Krzysztof Selmaj
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Wojewodzki Specjalistyczny Szpital w Olsztynie
Neurologiczny NZOZ Centrum Leczenia SM
Neuro-Care Gabriela Klodowska
Centrum Medyczne NeuroProtect
Hospital Garcia de Orta; Servico de Neurologia
Hospital de Braga
Centro Hospitalar E Universitário de Coimbra EPE
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Spitalul Universitar de Urgenta Elias; Oncologie Medicala
SC Clubul Sanatatii SRL
Siberian Medical Center
SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"
FGBU FNKC FMBA of Russia
SBIH City Polyclinic 2 of the Department of Health of the City of Moscow
SBIH of Nizhniy Novgorod region "City Clinical Hospital # 3"
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
Pavlov First Saint Petersburg State Medical University
SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk; Neurology Department
Sverdlovsk Regional Clinical Hospital 1
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
SAHI "Interregional Clinical and Diagnostic Center"
SAIH "Kemerovo Regional Clinical Hospital"
Kirov RSBIH "Kirov City Clinical Hospital # 1"
FSBIH Siberian Clinical Center of FMBA of Novosibirsk
Perm SMA n.a. academ. E.A. Vagner
SBEI HPE "Samara State Medical University" of the MoH of the RF
RSBIH "Smolensk Regional Clinical Hospital"
Saratov State Medical University
Clinical Center Kragujevac
Clinical Center Nis
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
Fakultna nemocnica s poliklinikou Zilina
Hospital Universitari de Bellvitge; Servicio de Neurologia
Hospital Santa Caterina
Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
Hospital Universitario Puerta de Hierro - Majadahonda
Hospital Universitario Virgen Macarena
Hospital de Basurto Servicio de Neurologia
Hospital Vall d'Hebron; Servicio de Neurología
Hospital Universitario de la Princesa; Servicio de Neurologia
Hospital Universitario Ramon y Cajal
Hospital Universitario Clínico San Carlos; Servicio de Neurología
Hospital Regional Universitario de Malaga
Sahlgrenska Sjukhuset
Akademiskt Specialist Centrum
Karolinska Universitetssjukhuset Huddinge
Universitaetsspital Basel
Ospedale Regionale di Lugano
Hopital Razi
Hopital Universitaire Fattouma Bourguiba
Istanbul University Cerrahpasa Medical Faculty
Ondokuz Mayis Univ. Med. Fac.; Neurology
Karadeniz Tecnical Uni. Med. Fac
Medical Center of Limited Liability Company Medical Center Saliutem
Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine
Medical Center of Limited Liability Company Medbud-Clinic
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
CMPI Chernihiv Regional Hospital; Reg.Cen.for Inflam.&demyelin.dis.of the CNS
CE I.I.Mechnykov Dnipropetrovsk RC Hosp Dept of Neurology DSMU
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Royal Devon and Exeter Hospital (Wonford)
Walton Centre For Neurology and Neurosurgery
Barts Health NHS Trust
Royal Victoria Infirmary
Nottingham University Hospitals Queen's Medical Centre
Morriston Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocrelizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0

Secondary Outcome Measures

Change in Expanded Disability Status Scale (EDSS) score over time

Change in 9-Hole Peg Test (9HPT) over time

Change in Timed 25-Foot Walk Test (T25FWT) over time

The number of T1 lesions and number of new or enlarging T2 lesions

The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume

Full Information

NCT ID

NCT05269004

First Posted

February 11, 2022

Last Updated

October 6, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT05269004

Brief Title

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

Acronym

OLERO

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 3, 2022 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ocrelizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ocrelizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0

Time Frame

Up to 44 months

Secondary Outcome Measure Information:

Title

Change in Expanded Disability Status Scale (EDSS) score over time

Time Frame