AzTrials
AzTrials

Multiple SclerosisPhase 3OLERONCT05269004

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

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, run by Hoffmann-La Roche at 236 sites in 37 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
236 sitesin 37 countries
Study dates
3 May 2022to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

236 sites in 37 countries.

236 sites in 37 countries

United States50 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327

  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina, 28203

  • The Neurological Institute PA

    Charlotte, North Carolina, 28204

  • Atrium Health

    Charlotte, North Carolina, 28207

  • Northwestern University

    Chicago, Illinois, 60611

  • University Neurology Inc.

    Cincinnati, Ohio, 45267-0502

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • Advanced Neurosciences Research LLC

    Fort Collins, Colorado, 80528

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Uni of Texas Health Science Center At Houston

    Houston, Texas, 77054

  • Indiana Univ School of Med

    Indianapolis, Indiana, 46202

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37934

  • MS Center of California

    Laguna Hills, California, 92653

  • Bhupesh Dihenia M.D. P.A.

    Lubbock, Texas, 79410

  • Neurology Associates PA

    Maitland, Florida, 32751

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Rutgers New Jersey Medical School Department of Neurology

    Newark, New Jersey, 07103

  • Consultants in Neurology Ltd

    Northbrook, Illinois, 60062

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104-5046

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-8440

  • Neurological Services of Orlando

    Orlando, Florida, 32806

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • South Shore Neurologic Associates PC

    Patchogue, New York, 11772

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Arizona Neuroscience Research LLC

    Phoenix, Arizona, 85032

  • Providence Neurological Specialties

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Neurology Center of San Antonio

    San Antonio, Texas, 78258

  • University of California San Francisco

    San Francisco, California, 94117

  • University of California San Francisco

    San Francisco, California, 94143

  • Swedish Neuroscience Research

    Seattle, Washington, 98122

  • Washington University

    St Louis, Missouri, 63110

  • SUNY at Stony Brook

    Stony Brook, New York, 11790

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • University of South Florida

    Tampa, Florida, 33612

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Vero Beach Neurology and Research Institute

    Vero Beach, Florida, 32860

  • Columbus Neuroscience

    Westerville, Ohio, 43082

Other trials in United States

Russia18 sites

  • Siberian Medical Center

    Barnaul, Altayskiy Kray, 656043

  • SAHI "Interregional Clinical and Diagnostic Center"

    Kazan, Vologda Oblast, 420101

  • SAIH "Kemerovo Regional Clinical Hospital"

    Kemerovo, 650066

  • Kirov RSBIH "Kirov City Clinical Hospital # 1"

    Kirov, 610014

  • FSBI 'Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Techno

    Moscow, Moscow Oblast, 115682

  • SBIH City Polyclinic 2 of the Department of Health of the City of Moscow

    Moscow, Moscow Oblast, 117556

  • FSBIH Siberian Clinical Center of FMBA of Novosibirsk

    Novosibirsk, 630007

  • SBEI HPE " Perm State Medical University n.a. Academician E.A. Vagner" of the MoH of the RF

    Perm, 614000

  • SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk

    Pyatigorsk, Stavropol Kray, 357538

  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

    Saint Petersburg, Sankt-Peterburg, 194044

  • SPb SBIH "City Multy-field Hospital # 2"

    Saint Petersburg, Sankt-Peterburg, 194354

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, Sankt-Peterburg, 197022

  • SBEI HPE "Samara State Medical University" of the MoH of the RF

    Samara, 443095

  • SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"

    Saransk, Respublika Mordoviya, 430032

  • Saratov State Medical University

    Saratov, 410012

  • RSBIH "Smolensk Regional Clinical Hospital"

    Smolensk, 214018

  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik

    Tyumen, Tyumen Oblast, 625000

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

Germany17 sites

  • Klinikum Bayreuth GmbH

    Bayreuth, Bavaria, 95445

  • Charité Universitaetsmedizin Berlin - Campus Ch

    Berlin, 10117

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

  • Neurologie in Bonn

    Bonn, 53111

  • Pharmakologisches Studienzentrum

    Chemnitz, Saxony, 09111

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Zentrum fuer ambulante Neurologie

    Essen, 45138

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60528

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

  • Universitaetsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Medizinische Einrichtungen des Bezirks Oberpfalz GmbH

    Regensburg, 93053

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Poland12 sites

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • COPERNICUS Podmiot Leczniczy Sp z o o

    Gda?sk, 80-803

  • M.A. LEK A.M.Maciejowscy SC.

    Katowice, 40-571

  • Specjal. Praktyka Lekarska

    Katowice, 40-588

  • Neuro-Medic Janusz Zbrojkiewicz

    Katowice, 40-686

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561

  • Neurologiczny NZOZ Centrum Leczenia SM

    Plewiska, 62-064

  • Neuro-Care Gabriela Klodowska

    Siemianowice ?l?skie, 41-100

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

Other trials in Poland

Italy11 sites

  • Fondazione Istituto G. Giglio di Cefalu

    Cefalù, Sicily, 90015

  • Azienda Socio Sanitaria Territoriale della Valle Olona (pres

    Gallarate, Aosta Valley, 21013

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    Genoa, Liguria, 16132

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Montichiari, Lombardy, 25018

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • Ospedale degli Infermi

    Ponderano, Friuli Venezia Giulia, 13875

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Lazio, 00133

  • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

    Rome, Lazio, 00189

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, The Marches, 60126

Other trials in Italy

Spain11 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Santa Caterina

    Salt, Girona, 17190

  • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

France10 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • Hopital Neurologique Pierre Wertheimer

    Bron, 69500

  • CHU CAEN - Hôpital de la Côte de Nacre

    Caen, Calvados, 14033

  • CHU Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hopital Roger Salengro Service de Neurologie

    Lille

  • CHU Nancy Hôpital Central

    Nancy, Meurthe Et Moselle, 54035

  • CHU Nice - Hôpital Pasteur 2

    Nice, 06002

  • Centre Hospitalier Intercommunal de Poissy

    Poissy, 78300

  • CHU Nantes Hopital Nord Laënnec

    Saint-Herblain, 44800

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, 67098

Other trials in France

Ukraine9 sites

  • CMPI Chernihiv Regional Hospital

    Chernihiv, KIEV Governorate, 14029

  • Separated structural unit ?University hospital? of Dnipro State Medical University

    Dnipro, Dnipropetrovsk Oblast, 49089

  • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, KIEV Governorate, 76008

  • Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine

    Kharkiv, Kharkiv Governorate, 61068

  • Medical Center of Limited Liability Company Medbud-Clinic

    Kyiv, KIEV Governorate, 03037

  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, Kharkiv Governorate, 79010

  • CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU

    Lviv, KIEV Governorate, 79010

  • CNE Odesa Regional Clinical Hospital of Odesa Regional Council

    Odesa, KIEV Governorate, 65025

  • Medical Center of Limited Liability Company Medical Center Saliutem

    Vinnytsia, Chernihiv Governorate, 21050

Other trials in Ukraine

Canada8 sites

  • Foothills Medical Centre Calgary

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 2C8

  • Clinique Neuro Outaouais

    Gatineau, Quebec, J8Y 1W2

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • St Michael Hospital

    Toronto, Ontario, M5B 1W8

  • UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Czechia8 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Neurospol s.r.o.

    Havirov-Podlesi, 73601

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Nemocnice Jihlava

    Jihlava, 58633

  • Pardubicka krajska nemocnice a.s.

    Pardubice, 532 03

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Krajska zdravotni a.s. - Nemocnice Teplice o.z.

    Teplice, 41529

Other trials in Czechia

Mexico8 sites

  • Hospital Angeles Chihuahua

    Chihuahua City, 31217

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020

  • Hospital Mexico Americano

    Guadalajara, Mexico CITY (federal District), 44610

  • Grupo Medico Camino

    México, 03100

  • Mexico Centre for Clinical Research

    Mexico City, Mexico CITY (federal District), 03100

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Centro de Estudios Clinicos y Especialidades Medicas S C

    Monterrey, Nuevo León, 64620

  • Clinical Research Institute

    Tlalnepantla, Mexico CITY (federal District), 54055

Other trials in Mexico

Brazil6 sites

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goinia, Goiás, 74605-020

  • Clinica Neurológica e Neurocirúrgica de Joinville

    Joinville, Santa Catarina, 89202-165

  • Hospital So Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • IMV Pesquisa Neurologica Sociedade Simples Ltda

    Porto Alegre, Rio Grande do Sul, 90620-130

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004

  • HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro

    Rio de Janeiro, 21941-913

Other trials in Brazil

Bulgaria6 sites

  • MHAT Avis Medica OOD Department of Neurology

    Pleven, 5800

  • MHATNP Sveti Naum EAD

    Sofia, 1113

  • University First MHAT-Sofia St. Joan Krastitel EAD

    Sofia, 1142

  • National Heart Hospital EAD

    Sofia, 1309

  • Acibadem City Clinic Tokuda Hospital Ead

    Sofia, 1407

  • Military Medical Academy MHAT Sofia Department of Rheumatology

    Sofia, 1606

Other trials in Bulgaria

United Kingdom6 sites

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Walton Centre For Neurology and Neurosurgery

    Liverpool, L9 7LJ

  • Barts Health NHS Trust

    London, E1 1BB

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP

  • Nottingham University Hospitals Queen's Medical Centre

    Nottingham, Nottinghamshire, NG7 2UH

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

Belgium5 sites

  • AZ Sint Jan

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZA

    Edegem, 2650

  • Algemeen Ziekenhuis Alma

    Eeklo, 9900

  • AZ Delta Campus Westlaan

    Roeselare, 8800

Other trials in Belgium

Israel4 sites

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 91120

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Portugal4 sites

  • Centro Clnico Acadmico - Braga, Associao (2CA-Braga)

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Garcia de Orta

    Pragal, 2808-267

Other trials in Portugal

Austria3 sites

  • Department Neurologie und Neurochirurgie

    Innsbruck, 6020

  • Barmherzige Brueder Konventspital

    Linz, 4040

  • AKH - Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Belarus3 sites

  • Grodno University Hospital

    Grodno, Brest Oblast, 230017

  • State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology

    Minsk, 2200045

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Hungary3 sites

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1044

  • Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

    Budapest, 1204

  • Pecsi Tudomanyegyetem

    Pécs, 7623

Other trials in Hungary

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

    Kaunas, LT-50161

  • Klaipeda University Hospital Public Institution

    Klaipėda, 92288

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Slovakia3 sites

  • MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

    Banská Bystrica, 974 04

  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov

    Bratislava, 821 01

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

Sweden3 sites

  • Sahlgrenska Sjukhuset

    Gothenburg, 41345

  • Akademiskt Specialist Centrum

    Stockholm, 113 65

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139

  • Karadeniz Tecnical Uni. Med. Fac

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Argentina2 sites

  • Hospital Español

    Ciudad Autonoma Bs As, 1209

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, 2000

Other trials in Argentina

Australia2 sites

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal North Shore Hospital

    St Leonards, New South Wales, NSW 2065

Other trials in Australia

Croatia2 sites

  • General Hospital Varazdin

    Varaždin, 42000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Latvia2 sites

  • Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology

    Riga, 1015

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Romania2 sites

  • Spitalul Universitar de Urgenta Elias

    Bucharest, 11461

  • SC Clubul Sanatatii SRL

    Campulung Muscel, 115100

Other trials in Romania

Serbia2 sites

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Switzerland2 sites

  • Universitaetsspital Basel

    Basel, 4031

  • Ospedale Regionale di Lugano

    Lugano, 6903

Other trials in Switzerland

Tunisia2 sites

  • Hopital Razi

    Mannouba, 2010

  • Hopital Universitaire Fattouma Bourguiba

    Monastir, 5000

Other trials in Tunisia

Finland1 site

  • Tammer Tutka Oy

    Tampere, 33200

Other trials in Finland

Netherlands1 site

  • Zuyderland Medisch Centrum - Sittard-Geleen'

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

New Zealand1 site

  • Waikato Hospital

    Hamilton, 3248

Other trials in New Zealand

Norway1 site

  • Haukeland Universitetssykehus

    Bergen, 5021

Other trials in Norway

About this 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

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.

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

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

Study groups in NCT05269004
Study groupRoleWhat they receive
OcrelizumabExperimentalParticipants 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.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 44 months

Secondary outcomes (5)

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

    Measured: Week 0, 24, 48, 72, 96, 120, 168

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

    Measured: Week 0, 24, 48, 72, 96, 120, 168

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

    Measured: Week 0, 24, 48, 72, 96, 120, 168

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

    Measured: Week 0, 24, 48, 72, 96, 120, 168

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

    Measured: Week 0, 24, 48, 72, 96, 120, 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start3 May 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269004
Sponsor's protocol ID
MN43964
Other IDs
2021-005746-15
Acronym
OLERO
Status last verified
Jul 2026
First submitted
11 Feb 2022
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, run by Hoffmann-La Roche at 236 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 236 sites in United States, Russia, Germany, Poland, Italy and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 (time frame: Up to 44 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05269004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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