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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Ocrelizumab
Avonex
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  • Relapsing-remitting multiple sclerosis (MS)
  • Ages 18-55 years inclusive
  • For sexually active female and male participants of reproductive potential, use of reliable means of contraception

Exclusion Criteria:

  • Secondary or primary progressive multiple sclerosis at screening
  • Incompatibility with MRI
  • Contra-indications to or intolerance of oral or IV corticosteroids
  • Known presence of other neurologic disorders
  • Pregnancy or lactation
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
  • Congestive heart failure
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
  • History or known presence of recurrent or chronic infection
  • History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
  • History of alcohol or drug abuse within 24 weeks prior to randomization
  • History of or currently active primary or secondary immunodeficiency
  • History of coagulation disorders
  • Treatment with any investigational agent within 4 weeks of screening
  • Receipt of a live vaccine within 6 weeks prior to randomization
  • Incompatibility with Avonex use
  • Previous treatment with rituximab
  • Previous treatment with lymphocyte-depleting therapies except mitoxantrone
  • Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
  • Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to randomization

Sites / Locations

  • Phoenix Neurological Associates Ltd
  • Barrow Neurological Institute
  • East Bay Physicians Med Group;Sutter East Bay Med Foundation
  • University of California San Francisco
  • Advanced Neurology of Colorado, LLC
  • Bradenton Research Center
  • MS Center of Vero Beach
  • Shepherd Center; Multiple Sclerosis Center
  • University of Chicago; Neurology
  • Kansas University Medical Center
  • John Hopkins University
  • Michigan Institute for Neurological Disorders
  • Dartmouth-Hitchcock Medical Center; Dept of Neurology
  • Columbia University Medical Center; The Neurological Institute of New York
  • Island Neurological Associates, P.C.
  • Suny At Stony Brook; Department Of Neurology
  • The Neurological Institute PA
  • Clinical Research of Winston Salem
  • Cleveland Clinic
  • Ohio State University Med Ctr; MS Center
  • Legacy Health System; Clinical Research & Tech Ctr
  • Vanderbilt University Medical Center
  • Baylor College of Medicine
  • Integra Clinical Research, Llc
  • Fletcher Allen Health Care/University of Vermont
  • University of Virginia - Fontain Research Park
  • UZ Antwerpen
  • First MHAT; Clinic of Neurology
  • Shat of Cardiovascular Diseases; Clinic of Neurology
  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
  • UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
  • CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
  • Military Medical Academy; Neurology
  • Uni of British Columbia Hospital; Ms Clinical Research Group
  • St. Michael'S Hospital
  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric
  • Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
  • Krajska Nemocnice Pardubice Neurologicka Klinika
  • Fakultni nemocnice Motol; Neurologicka klinika
  • Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
  • CHU De Caen; Service De Neurologie Dejerine
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
  • St. Joseph-Krankenhaus
  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • Asklepios Klinik Nord-Heidberg; Neurologie
  • Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
  • Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
  • Hospital CIMA, Sta. Engracia
  • Instituto Biomedico De Investigacion A.C.
  • Unidad de Investigacion CIMA SC
  • Hospital Cima Chihauhau
  • Spitalul Clinic Colentina; Clinica de Neurologie
  • Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
  • Central Clinical Hospital #2 N.A. Semashko OAO RJHD
  • Municipal City Hospital #33; Neurology
  • SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
  • LLC Research Medical Complex Vashe Zdorovie
  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
  • MRC for Oncology and Neurology; Neurology
  • Clinical Center of Serbia; Institute of Neurology
  • Clinical Center Nis; Clinic for Mental Health
  • Clinic of Neurology
  • Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
  • Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
  • Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
  • Fakultna Nemocnica Nitra; Neurologicka Klinika
  • Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Hospital Clinic i Provincial; Servicio de Neurologia
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Hospital Universitario La Fe; Unidad de Esclerosis Multiple
  • Universitätsspital Basel; Neurologie
  • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
  • City Clin.Hosp #4; Dept. of Neurology
  • Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
  • Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
  • Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
  • Uni Hospital Queens Medical Centre; Neurology
  • Royal Hallamshire Hospital; Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Placebo

Ocrelizumab 600 mg

Ocrelizumab 1000 mg

Avonex

Arm Description

Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.

Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.

Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Outcomes

Primary Outcome Measures

Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.

Secondary Outcome Measures

Annualized Protocol Defined Relapse Rate at Week 24
Adjusted annualized relapse rate for geographical region.
Percentage of Participants Who Remained Relapse Free at Week 24
Percentage of participants who remained relapse free at week 24 were reported.
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
Total Number of Gadolinium-Enhancing T1 Lesions at Weeks
Total number of gadolinium-enhancing T1 lesions at weeks were reported.

Full Information

First Posted
May 9, 2008
Last Updated
October 5, 2023
Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00676715
Brief Title
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title
Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2008 (Actual)
Primary Completion Date
March 9, 2012 (Actual)
Study Completion Date
December 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG

4. Oversight

5. Study Description

Brief Summary
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Arm Title
Ocrelizumab 600 mg
Arm Type
Experimental
Arm Description
Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Arm Title
Ocrelizumab 1000 mg
Arm Type
Experimental
Arm Description
Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Arm Title
Avonex
Arm Type
Active Comparator
Arm Description
Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Avonex
Other Intervention Name(s)
Interferon-beta-alpha1
Intervention Description
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Primary Outcome Measure Information:
Title
Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain
Description
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
Time Frame
Week 12 to Week 24
Secondary Outcome Measure Information:
Title
Annualized Protocol Defined Relapse Rate at Week 24
Description
Adjusted annualized relapse rate for geographical region.
Time Frame
Week 24
Title
Percentage of Participants Who Remained Relapse Free at Week 24
Description
Percentage of participants who remained relapse free at week 24 were reported.
Time Frame
Week 24
Title
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Description
Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.
Time Frame
Baseline, Week 24
Title
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Description
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
Time Frame
Weeks 4 to Week 24
Title
Total Number of Gadolinium-Enhancing T1 Lesions at Weeks
Description
Total number of gadolinium-enhancing T1 lesions at weeks were reported.
Time Frame
Weeks 4 to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent and to be compliant with the schedule of protocol assessments Relapsing-remitting multiple sclerosis (MS) Ages 18-55 years inclusive For sexually active female and male participants of reproductive potential, use of reliable means of contraception Exclusion Criteria: Secondary or primary progressive multiple sclerosis at screening Incompatibility with MRI Contra-indications to or intolerance of oral or IV corticosteroids Known presence of other neurologic disorders Pregnancy or lactation Lack of peripheral venous access History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal Congestive heart failure Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening History or known presence of recurrent or chronic infection History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved) History of alcohol or drug abuse within 24 weeks prior to randomization History of or currently active primary or secondary immunodeficiency History of coagulation disorders Treatment with any investigational agent within 4 weeks of screening Receipt of a live vaccine within 6 weeks prior to randomization Incompatibility with Avonex use Previous treatment with rituximab Previous treatment with lymphocyte-depleting therapies except mitoxantrone Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization Systemic corticosteroid therapy within 4 weeks prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Neurological Associates Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
East Bay Physicians Med Group;Sutter East Bay Med Foundation
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Advanced Neurology of Colorado, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
MS Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Shepherd Center; Multiple Sclerosis Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Chicago; Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
John Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Michigan Institute for Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center; Dept of Neurology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Columbia University Medical Center; The Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Island Neurological Associates, P.C.
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Suny At Stony Brook; Department Of Neurology
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
The Neurological Institute PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Clinical Research of Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University Med Ctr; MS Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Legacy Health System; Clinical Research & Tech Ctr
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Integra Clinical Research, Llc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fletcher Allen Health Care/University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
5405
Country
United States
Facility Name
University of Virginia - Fontain Research Park
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
First MHAT; Clinic of Neurology
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Shat of Cardiovascular Diseases; Clinic of Neurology
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Military Medical Academy; Neurology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Uni of British Columbia Hospital; Ms Clinical Research Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Krajska Nemocnice Pardubice Neurologicka Klinika
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Fakultni nemocnice Motol; Neurologicka klinika
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU De Caen; Service De Neurologie Dejerine
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
St. Joseph-Krankenhaus
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Asklepios Klinik Nord-Heidberg; Neurologie
City
Hamburg
ZIP/Postal Code
22417
Country
Germany
Facility Name
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Hospital CIMA, Sta. Engracia
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Instituto Biomedico De Investigacion A.C.
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Unidad de Investigacion CIMA SC
City
Chihuahua
ZIP/Postal Code
31200
Country
Mexico
Facility Name
Hospital Cima Chihauhau
City
Chihuahua
ZIP/Postal Code
31328
Country
Mexico
Facility Name
Spitalul Clinic Colentina; Clinica de Neurologie
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Municipal City Hospital #33; Neurology
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
LLC Research Medical Complex Vashe Zdorovie
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
4420029
Country
Russian Federation
Facility Name
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
City
Tyumen
State/Province
Tjumen
ZIP/Postal Code
625048
Country
Russian Federation
Facility Name
MRC for Oncology and Neurology; Neurology
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Facility Name
Clinical Center of Serbia; Institute of Neurology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Nis; Clinic for Mental Health
City
NIS
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinic of Neurology
City
Nova Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
City
Kosice
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
Fakultna Nemocnica Nitra; Neurologicka Klinika
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitätsspital Basel; Neurologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
City Clin.Hosp #4; Dept. of Neurology
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
City
Propetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Uni Hospital Queens Medical Centre; Neurology
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital; Neurology
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22047971
Citation
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.
Results Reference
derived

Learn more about this trial

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

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