A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

PHASE2CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

July 17, 2008

Primary Completion Date

March 9, 2012

Study Completion Date

November 8, 2023

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Placebo

Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.

DRUG

Ocrelizumab

Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.

DRUG

Avonex

Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.

Trial Locations (84)

1000

First MHAT; Clinic of Neurology, Sofia

1309

Shat of Cardiovascular Diseases; Clinic of Neurology, Sofia

1407

ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine, Sofia

1527

UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY, Sofia

1606

CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY, Sofia

Military Medical Academy; Neurology, Sofia

2650

UZ Antwerpen, Edegem

4031

Universitätsspital Basel; Neurologie, Basel

5405

Fletcher Allen Health Care/University of Vermont, Burlington

8200

Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken, Aarhus N

10032

Columbia University Medical Center; The Neurological Institute of New York, New York

11000

Clinical Center of Serbia; Institute of Neurology, Belgrade

11794

Suny At Stony Brook; Department Of Neurology, Stony Brook

11803

Island Neurological Associates, P.C., Plainview

13088

St. Joseph-Krankenhaus, Berlin

13347

Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie, Berlin

14033

CHU De Caen; Service De Neurologie Dejerine, Caen

18000

Clinical Center Nis; Clinic for Mental Health, Niš

20127

Instituto Biomedico De Investigacion A.C., Aguascalientes

21000

Clinic of Neurology, Nova Sad

21005

Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases, Vinnytsia

21205

John Hopkins University, Baltimore

22417

Asklepios Klinik Nord-Heidberg; Neurologie, Hamburg

22903

University of Virginia - Fontain Research Park, Charlottesville

27103

Clinical Research of Winston Salem, Winston-Salem

28034

Hospital Ramon y Cajal; Servicio de Neurologia, Madrid

28204

The Neurological Institute PA, Charlotte

29010

Hospital Regional Universitario Carlos Haya; Servicio de Neurologia, Málaga

30029

CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge, Nîmes

30309

Shepherd Center; Multiple Sclerosis Center, Atlanta

31200

Unidad de Investigacion CIMA SC, Chihuahua City

31328

Hospital Cima Chihauhau, Chihuahua City

32960

MS Center of Vero Beach, Vero Beach

33076

Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie, Bordeaux

34205

Bradenton Research Center, Bradenton

35039

Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie, Marburg

37212

Vanderbilt University Medical Center, Nashville

41009

Hospital Universitario Virgen Macarena; Servicio de Neurologia, Seville

43221

Ohio State University Med Ctr; MS Center, Columbus

44106

Cleveland Clinic, Cleveland

46026

Hospital Universitario La Fe; Unidad de Esclerosis Multiple, Valencia

48334

Michigan Institute for Neurological Disorders, Farmington Hills

49027

Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states, Propetrovsk

60637

University of Chicago; Neurology, Chicago

61068

Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology, Kharkiv

63003

Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B, Clermont-Ferrand

64060

Hospital CIMA, Sta. Engracia, Monterrey

66103

Kansas University Medical Center, Kansas City

77030

Baylor College of Medicine, Houston

78229

Integra Clinical Research, Llc, San Antonio

80528

Advanced Neurology of Colorado, LLC, Fort Collins

85006

Phoenix Neurological Associates Ltd, Phoenix

85013

Barrow Neurological Institute, Phoenix

94117

University of California San Francisco, San Francisco

94705

East Bay Physicians Med Group;Sutter East Bay Med Foundation, Berkeley

97062

Legacy Health System; Clinical Research & Tech Ctr, Tualatin

107150

Central Clinical Hospital #2 N.A. Semashko OAO RJHD, Moskva

540136

Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie, Târgu Mureş

603076

Municipal City Hospital #33; Neurology, Nizhny Novgorod

620102

SHI Sverdlovsk Regional Clinical Hospital #1;Neurology, Yekaterinburg

625048

Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology, Tyumen

630090

MRC for Oncology and Neurology; Neurology, Novosibirsk

4420029

LLC Research Medical Complex Vashe Zdorovie, Kazan'

03756

Dartmouth-Hitchcock Medical Center; Dept of Neurology, Lebanon

V6T 2B5

Uni of British Columbia Hospital; Ms Clinical Research Group, Vancouver

M5B 1W8

St. Michael'S Hospital, Toronto

H3A 2B4

McGill University; Montreal Neurological Institute; Neurological and Psychiatric, Montreal

708 52

Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU, Ostrava

532 03

Krajska Nemocnice Pardubice Neurologicka Klinika, Pardubice

150 06

Fakultni nemocnice Motol; Neurologicka klinika, Prague

415 29

Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum, Teplice

00189

Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla, Rome

020125

Spitalul Clinic Colentina; Clinica de Neurologie, Bucharest

975 17

Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu, Banská Bystrica

813 69

Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology, Bratislava

041 66

Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika, Košice

949 01

Fakultna Nemocnica Nitra; Neurologicka Klinika, Nitra

05201

Nemocnica s Poliklinikou Spisska Nova Ves, a.s., Spišská Nová Ves

08035

Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia, Barcelona

08036

Hospital Clinic i Provincial; Servicio de Neurologia, Barcelona

03110

City Clin.Hosp #4; Dept. of Neurology, Kyiv

L9 7LJ

Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT, Liverpool

NG7 2UH

Uni Hospital Queens Medical Centre; Neurology, Nottingham

S10 2JF

Royal Hallamshire Hospital; Neurology, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Genentech, Inc.

INDUSTRY

NCT00676715 - A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | Biotech Hunter | Biotech Hunter