A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,013

Participants

Timeline

Start Date

August 12, 2019

Primary Completion Date

January 15, 2025

Study Completion Date

January 19, 2028

Conditions
Multiple Sclerosis, Primary Progressive
Interventions
DRUG

Ocrelizumab

The first dose of ocrelizumab will be administered as two 300 milligrams (mg), IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusion, should be maintained between each infusion.

DRUG

Placebo

The first dose of placebo will be administered as two IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusions, maintained between each infusion.

Trial Locations (159)

179

Khechinashvili University Hospital, Tbilisi

1008

Military Hospital of Tunis, Tunis

1113

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD, Sofia

1200

Cliniques Universitaires St-Luc, Brussels

2010

Hopital Razi, LA Mannouba

2050

Brain and Mind Research Institute, Camperdown

2650

UZ Antwerpen, Edegem

3029

Hospital Habib Bourguiba, Sfax

3050

Royal Melbourne Hospital, Parkville

3084

Austin Hospital, Heidelberg

3900

MS & Neurologisch Revalidatie Centrum, Overpelt

5000

Fattouma Bourguiba University Hospital, Monastir

5800

Military Medical Academy HBAT, Pleven

Multiprofile Hospital For Active Treatment Avis Medica, Pleven

8011

New Zealand Clinical Research - Christchurch, Christchurch

10000

Clinical Hospital Sestre Milosrdnice, Zagreb

University Hospital Center Zagreb, Zagreb

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano

10100

Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites, Rabat

11000

Military Medical Academy, Belgrade

University Clinical Center of Serbia -PPDS, Belgrade

11080

Clinical Hospital Centre Zemun, Belgrade

14050

Unidad de Investigacion en Salud de Chihuahua, Mexico City

16132

IRCCS Ospedale Policlinico San Martino, Genoa

18000

Clinical Center Nis, Niš

19141

Albert Einstein Medical Center, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

21000

Clinical Centre of Vojvodina, Nova Sad

21009

Medical Center Salutem, Vinnytsia

LLC Medical Center Health Clinic, Vinnytsia

25005

Treatment and Diagnostic Center of LLC MRT Elit, Kropyvnytskyi

27100

Fondazione Istituto Neurologico Mondino IRCCS, Pavia

28034

Hospital Universitario Ramon y Cajal, Madrid

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

30120

Hospital Universitario Virgen de La Arrixaca, El Palmar

30900

CHU de Nimes - Hopital Universitaire Caremeau, Nîmes

31000

Clinical Hospital Centre Osijek, Osijek

General Hospital Uzice, Užice

31238

Hospital Angeles Chihuahua, Chihuahua City

32806

Neurological Services of Orlando, Orlando

32960

Vero Neurology, Vero Beach

33076

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux

33761

MS and Neuromuscular Center of Excellence, Clearwater

34000

University Clinical Center Kragujevac, Kragujevac

36312

Complejo Hospitalario Universitario de Vigo, Vigo

37007

Complejo Asistencial Universitario de Salamanca ? H. Clinico, Salamanca

40080

CHU Mohammed VI, Marrakesh

41009

Hospital Universitario Virgen Macarena, Seville

42000

General Hospital Varazdin, Varaždin

43005

Volyn Regional Clinical Hospital, Lutsk

44805

Hopital Guillaume Et Rene Laennec, Nantes

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48035

Michigan Neurology Associates P.C., Clinton Township

49089

University hospital of Dnipro State Medical University, Dnipro

49600

LLC Medical Center Family Medicine Clinic, Dnipro

50012

Instituto Neurologico de Colombia INDEC, Medellín

54035

CHRU Nancy, Nancy

54055

Clinical Research Institute, Tlalnepantla

61022

Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv

63003

Centre Hospitalier Universitaire de Clermont Ferrand, Clermont-Ferrand

66160

University of Kansas Medical Center, Kansas City

67098

Hopital Civil, Strasbourg

69000

LLC Medical Center Unimed, Zaporizhzhia

69035

LLC Medical Center INET 09, Zaporizhzhia

69600

Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council, Zaporizhzhia

73000

Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh, Kherson

76493

Treatment and diagnostic Center Neuro Global of LLC Neuro Global, Krykhivtsi

77030

Maxine Mesinger MS Clinic/Baylor College of Medicine, Houston

79010

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

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

80020

Neurociencias Estudios Clinicos S.C., Culiacán

80138

AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2, Napoli

88018

Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RC, Uzhhorod

90015

Fondazione Istituto G. Giglio di Cefalu, Cefalù

92653

Multiple Sclerosis Center of California, Laguna Hills

111321

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia, Bogotá

115100

SC Clubul Sanatatii SRL, Campulung Muscel

115516

City Clinical Hospital a n Buyanov V M, Moscow

125367

Research Center of Neurology of RAMS, Moskva

127015

City Clinical Hospital #24, Moscow

129110

Moscow Regional Research Clinical Institute Na Mfvladimirskiy, Moscow

197110

National Center of Socially Significant Diseases, Saint Petersburg

197706

City Hospital #40 of Kurortniy Administrative District, Saint Petersburg

330084

Spitalul Judetean de Urgenta Deva, Deva

420043

Vertebronevrologiya LLC, Kazan'

430032

City Clinical Hospital #4, Saransk

432063

Ulyanovsk Regional Clinical Hospital, Ulyanovsk

540136

Targu Mures Clinical Emergency County Hospital, Târgu Mure?

603126

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko, Nizhny Novgorod

603137

MEDIS Limited Liability Company, Nizhny Novgorod

603155

SBHI of Nizhny Novgorod region City Clinical Hospital #3, Nizhny Novgorod

610027

Kirov State Medical Academy, Kirov

614990

Perm Regional Clinical Hospital of Znak Pocheta Medal, Perm

620102

Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg

625000

Neftyanik Medical and Sanitary Unit, Tumen

630007

FSBIH Siberian Regional Medical Centre of FMBA of Russia, Novosibirsk

634050

Siberian State Medical University of Roszdrav, Tomsk

650066

Belyayev Clinical Hospital of the Kuzbass, Kemerovo

660022

Krasnoyarsk State Medical Academy, Krasnoyarsk

900123

Cai Ferate Clinical Hospital, Constanța

43235-5422

The Boster Center for MS, Columbus

43082-6910

Columbus Neuroscience, Westerville

T6G 2G3

University of Alberta, Edmonton

B3H 4K4

Dalhousie Multiple Sclerosis Research Unit, Halifax

M5B 1W8

St. Michael's Hospital, Toronto

J4V 2J2

Recherche Sepmus Inc., Greenfield Park

0114

Pineo Medical Ecosystem LTD, Tbilisi

0141

The First University Clinic of Tbilisi State Medical University, Tbilisi

00133

Fondazione PTV Policlinico Tor Vergata, Rome

00189

Azienda Ospedaliera Sant'andrea, Rome

000000

Hotel Dieu de France, Achrafieh Beirut

DUMMY_VALUE

Saint George University Medical Hospital, El Achrafiyé

03310

Grupo Medico Camino, Mexico City

Unknown

Dunedin Hospital, Dunedin

85-796

Neurocentrum Bydgoszcz sp z o.o, Bydgoszcz

50-220

Przychodnia EuroMediCare, Wroclaw

20-410

Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak, Lublin

35-055

Centrum Medyczne Medyk, Rzeszów

44-200

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3, Rybnik

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a, Bia?ystok

80-803

Copernicus Podmiot Leczniczy Sp z o o, Gda?sk

05-825

Mazowieckie Centrum Badan Klinicznych, Grodzisk Mazowiecki

40-571

MA-LEK Clinical Sp. Z o.o., Katowice

40-584

Novo-Med Zielinski i wsp SpJ, Katowice

40-686

NEURO-MEDIC Sp. z o. o., Katowice

40-752

Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo, Katowice

31-503

Szpital Uniwersytecki w Krakowie, Krakow

90-324

Centrum Neurologii Krzysztof Selmaj, Lodz

20-064

Galen Clinic, Lublin

10-561

Wojewodzki Szpital Specjalistyczny, Olsztyn

60-693

Med-Polonia Sp. z o.o., Poznan

70-215

EUROMEDIS Sp z o o, Szczecin

01-684

Centrum Medyczne NeuroProtect Zablocinska 10, Warsaw

25-726

RESMEDICA Spolka z o.o., Kielce

2674-514

ULS de Loures-Odivelas, EPE - Hospital de Loures, Loures

2805-267

Hospital Garcia de Orta, Almada

4710-243

Hospital de Braga, Braga

4099-001

Hospital de Santo Antonio, Porto

2560-280

Campus Neurologico Senior, Torres Vedras

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

03037

Medical Centre of PE First Private Clinic, Kyiv

03110

Kyiv City Clinical Hospital #4, Kyiv

04070

Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv City, Kyiv

02002

Medical Center Artes Medicum LLC, Kyiv

02000

Medical Center of LLC Medical Center Dopomoga Plus, Kyiv

04219

Private Enterprise Clinic Medicom, Kyiv

CF14 4XW

University Hospital of Wales, Cardiff

G51 4TF

Queen Elizabeth University Hospital - PPDS, Glasgow

IV2 3JH

Raigmore Hospital - PPDS, Inverness

E1 1BB

The Royal London Hospital, London

WC1N 3BG

The National Hospital for Neurology & Neurosurgery, London, GT LON

NG7 2UH

University of Nottingham, Nottingham

PL6 8BX

Peninsula College of Medicine and Dentistry, Plymouth

M6 8HD

Salford Royal Hospital, Salford

S10 2JF

Royal Hallamshire Hospital, Sheffield

SA6 6NL

Morriston Hospital, Swansea

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04035005 - A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | Biotech Hunter | Biotech Hunter