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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

Primary Purpose

Relapsing Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1a
Ocrelizumab-matching placebo
Ocrelizumab
Interferon beta-1a-matching placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS score less than or equal to (</=) 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or IV corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use

Sites / Locations

  • Hope Research Institute
  • HonorHealth Neurology
  • Territory Neurology and Research Institute
  • Collaborative Neuroscience Research, LLC
  • Stanford University Medical Center
  • University of Colorado
  • Advanced Neurosciences Research LLC
  • Associated Neurologists of Southern CT PC
  • Infinity Clinical Research
  • University of Miami; Dept. of Neurology MS Center
  • Neurological Services of Orlando
  • Lovelace Scientific Resources
  • University of South Florida
  • Atlanta Neuroscience Institute
  • Josephson Wallack Munshower Neurology PC
  • University of Kansas Medical Center
  • MidAmerica Neuroscience Institute
  • Associates in Neurology PSC
  • Dragonfly Research, LLC
  • University of Massachusetts Memorial Medical Center
  • University of Michigan Health System
  • Wayne State University; Department of Neurology
  • The Minneapolis Clinic of Neurology
  • Rutgers New Jersey Medical School
  • Holy Name Hospital
  • MS Comprehensive Care Center
  • Shore Neurology
  • Empire Neurology, PC
  • Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
  • South Shore Neurologic Associates P.C.
  • University of Rochester Medical Center
  • SUNY at Stony Brook
  • The Neurological Institute PA
  • Neurology Associates PA
  • Raleigh Neurology Associates
  • Columbus Neuroscience
  • Abington Neurological Associates
  • Absher Neurology PA
  • Neurology Clinic PC
  • Sibyl Wray MD Neurology PC
  • Advanced Neurosciences Institute
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine
  • Bhupesh Dihenia M.D. P.A.
  • Central Texas Neurology Consultants
  • Integra Clinical Research, Llc
  • Neurology Center of San Antonio
  • Swedish Neuroscience Institute
  • ALPI-Inst. de Rehabilitacion Marcelo Fitte
  • STAT Research S.A.
  • Grodno State Medical University
  • City Clinical Hospital #9
  • Vitebsk; Regional Diagnostic Center
  • Vitebsk Regional Clinical Hospital
  • UZ Antwerpen
  • University Clinic Ctr Sarajevo
  • Uni Hospital Center Tuzla
  • Santa Casa de Misericordia; de Belo Horizonte
  • Hospital Universitario Gaffree e Guinle
  • Hospital das Clinicas - UNICAMP
  • MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases
  • Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit
  • MHAT National Cardiology Hospital, EAD; Neurology
  • UMHAT Alexandrovska, EAD; Neurology
  • Multiple Sclerosis Clinic
  • University of Alberta; Northern Alberta Trials & Research Centre
  • Vancouver Hospital - UBC Hospital Site
  • The Ottawa Hospital - General Campus
  • Clinique NeuroOutaouais
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital
  • Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie
  • General Hospital Pula
  • General Hospital Varazdin
  • Clinical Hospital Centre Zagreb;Clinic for Neurology
  • Uni Hospital Centre Dubrava
  • Fakultni nemocnice Brno
  • Neurospol s.r.o.
  • Pardubicka Krajska Nemocnice; Department of Neurology
  • Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
  • Hopital Neurologique Pierre Wertheimer
  • Hôpital General - Service de neurologie; Service de neurologie
  • Hôpital Saint Philibert
  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital Maison Blanche; Service de Neurologie
  • CHU toulouse - Hôpital Purpan; Departement de Neurologie
  • Sankt Gertrauden Krankenhaus; Neurologisches Facharztzentrum
  • Neurologische Praxis Bonn
  • Universitätsklinikum Düsseldorf; Klinik für Neurologie
  • Zentrum fuer ambulante Neurologie
  • Universitaetsklinikum Frankfurt; Klinik für Neurologie
  • Universitaetsklinikum Heidelberg
  • Ratsapotheke Mittweida
  • Klinikum Grosshadern der LMU
  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
  • Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber
  • St Vincents University Hospital
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Policlinico Universitario Agostino Gemelli
  • A.O. Universitaria S. Martino Di Genova
  • Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna
  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Ospedale degli Infermi
  • Ospedale Generale Regionale F. Miulli
  • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Fond. Ist. S. Raffaele - giglio
  • Mexico Centre for Clinical Research
  • Clinical Research Institute
  • Instituto Biomedico De Investigacion A.C.
  • Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4
  • Hospital Angeles Culiacan; Neurociencias
  • Hospital Mexico Americano SC; Departamento de Electroencefalografía
  • Haukeland Universitetssykehus
  • Vitamed
  • MA-LEK Clinical Sp. Z o.o.
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
  • Centrum Neurologii Krzysztof Selmaj
  • Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie
  • Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym
  • Neuro-Care Gabriela Klodowska
  • mMED Maciej Czarnecki
  • State institution of health care - Territorial Clinical Hospital
  • State autonomous institution of healthcare Inter-regional clinical and diagnostic center
  • Kirov City Clinical Hospital #1; Neurology Department
  • SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
  • Perm SMA n.a. academ. E.A. Vagner
  • City Clinical Hospital#2
  • St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
  • Saratov State Medical University of RosZdrav; Neurology
  • MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
  • Fakultna Nemocnica Roosevelta
  • Vseobecna nemocnica s poliklinikou Levoca a.s.
  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol
  • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Hospital General Univ. de Alicante
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Hospital Universitario Clinico San Carlos
  • Hospital Regional Universitario de Malaga
  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
  • Sahlgrenska Sjukhuset; Neurology
  • Karolinska Universitetssjukhuset Solna Neurology
  • Karolinska Universitetssjukhuset Huddinge
  • Norrlands Universitetssjukhus
  • Hacettepe University Medical Faculty; Neurology
  • Haseki Training and Research Hospital
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Istanbul Bilim Universty Medical Fac.
  • Ege University Medical Faculty
  • Kocaeli University Medical Faculty
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department
  • City Clinical Hospital #4
  • State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a
  • Road Clinical Hospital of Donetsk Station; Neurology Department
  • Regional Clinical Hospital; Neurology Department
  • Royal Devon and Exeter Hospital (Wonford)
  • Kings College Hospital; Neurosciences Clinical Trials Office
  • City General Hospital; Department of Neurology
  • Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interferon beta-1a 44 mcg SC

Ocrelizumab

Arm Description

Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.

Secondary Outcome Measures

Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Number of T1 Hypointense Lesions During the Double-Blind Treatment
The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96
MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96
Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).
Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96
NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.
Number of Participants With Adverse Events (AEs)
AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.
Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)
AUC represents total drug exposure for one dosing interval after the 4th dose.
Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.

Full Information

First Posted
August 8, 2011
Last Updated
March 2, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01412333
Brief Title
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Official Title
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2011 (Actual)
Primary Completion Date
May 12, 2015 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
835 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon beta-1a 44 mcg SC
Arm Type
Active Comparator
Arm Description
Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Rebif
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab-matching placebo
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a-matching placebo
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
Description
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
Description
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Time Frame
Week 104
Title
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
Description
The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Time Frame
Baseline up to week 96
Title
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
Description
The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
Time Frame
Baseline up to week 96
Title
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
Description
Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.
Time Frame
Week 96
Title
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period
Description
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Time Frame
Week 104
Title
Number of T1 Hypointense Lesions During the Double-Blind Treatment
Description
The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.
Time Frame
Baseline up to week 96
Title
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96
Description
MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
Time Frame
Baseline, Week 96
Title
Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96
Description
Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).
Time Frame
From week 24 up to week 96
Title
Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96
Description
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time Frame
Baseline, Week 96
Title
Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96
Description
NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.
Time Frame
Week 96
Title
Number of Participants With Adverse Events (AEs)
Description
AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.
Time Frame
Baseline up to Week 96
Title
Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)
Description
AUC represents total drug exposure for one dosing interval after the 4th dose.
Time Frame
Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96
Title
Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
Description
Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.
Time Frame
Baseline up to Week 96

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: Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010) At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening) Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive Exclusion Criteria: Primary progressive multiple sclerosis Disease duration of more than 10 years in patients with EDSS score less than or equal to (</=) 2.0 at screening Contraindications for MRI Known presence of other neurological disorders which may mimic multiple sclerosis Pregnancy or lactation Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study History of or currently active primary or secondary immunodeficiency History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis, tuberculosis) History of progressive multifocal leukoencephalopathy Contraindications to or intolerance of oral or IV corticosteroids Contraindications to Rebif or incompatibility with Rebif use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Territory Neurology and Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Advanced Neurosciences Research LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Associated Neurologists of Southern CT PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University of Miami; Dept. of Neurology MS Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Neuroscience Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Josephson Wallack Munshower Neurology PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Associates in Neurology PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Dragonfly Research, LLC
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0666
Country
United States
Facility Name
Wayne State University; Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
MS Comprehensive Care Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Shore Neurology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
City
New York
State/Province
New York
ZIP/Postal Code
63110
Country
United States
Facility Name
South Shore Neurologic Associates P.C.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
The Neurological Institute PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Neurology Associates PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
Columbus Neuroscience
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43801
Country
United States
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Absher Neurology PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Sibyl Wray MD Neurology PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Bhupesh Dihenia M.D. P.A.
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integra Clinical Research, Llc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
ALPI-Inst. de Rehabilitacion Marcelo Fitte
City
Buenos Aires
ZIP/Postal Code
C1425BWO
Country
Argentina
Facility Name
STAT Research S.A.
City
Ciudad de Buenos Airesa
ZIP/Postal Code
C1013AAB
Country
Argentina
Facility Name
Grodno State Medical University
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
City Clinical Hospital #9
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Vitebsk; Regional Diagnostic Center
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210032
Country
Belarus
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Clinic Ctr Sarajevo
City
Sarajevo
ZIP/Postal Code
71 000
Country
Bosnia and Herzegovina
Facility Name
Uni Hospital Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital Universitario Gaffree e Guinle
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20270-004
Country
Brazil
Facility Name
Hospital das Clinicas - UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-887
Country
Brazil
Facility Name
MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT National Cardiology Hospital, EAD; Neurology
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
UMHAT Alexandrovska, EAD; Neurology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Multiple Sclerosis Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta; Northern Alberta Trials & Research Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Vancouver Hospital - UBC Hospital Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Clinique NeuroOutaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
General Hospital Pula
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb;Clinic for Neurology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Uni Hospital Centre Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Neurospol s.r.o.
City
Havirov
ZIP/Postal Code
736 00
Country
Czechia
Facility Name
Pardubicka Krajska Nemocnice; Department of Neurology
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Hôpital General - Service de neurologie; Service de neurologie
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Saint Philibert
City
Lommé
ZIP/Postal Code
59462
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Maison Blanche; Service de Neurologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU toulouse - Hôpital Purpan; Departement de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Sankt Gertrauden Krankenhaus; Neurologisches Facharztzentrum
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Neurologische Praxis Bonn
City
Bonn
ZIP/Postal Code
53117
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf; Klinik für Neurologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Zentrum fuer ambulante Neurologie
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt; Klinik für Neurologie
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Ratsapotheke Mittweida
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Klinikum Grosshadern der LMU
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
St Vincents University Hospital
City
Dublin 4
Country
Ireland
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
City
Torrette - Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy
Facility Name
Ospedale degli Infermi
City
Ponderano
State/Province
Piemonte
ZIP/Postal Code
13875
Country
Italy
Facility Name
Ospedale Generale Regionale F. Miulli
City
Acquaviva delle Fonti
State/Province
Puglia
ZIP/Postal Code
70021
Country
Italy
Facility Name
Ospedale Casa Sollievo Della Sofferenza IRCCS
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Fond. Ist. S. Raffaele - giglio
City
Cefalu
State/Province
Sicilia
ZIP/Postal Code
90015
Country
Italy
Facility Name
Mexico Centre for Clinical Research
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Clinical Research Institute
City
Tlalnepantla de Baz
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Instituto Biomedico De Investigacion A.C.
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Hospital Angeles Culiacan; Neurociencias
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Hospital Mexico Americano SC; Departamento de Electroencefalografía
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-021
Country
Poland
Facility Name
MA-LEK Clinical Sp. Z o.o.
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Neuro-Care Gabriela Klodowska
City
Siemianowice ?l?skie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
mMED Maciej Czarnecki
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
State institution of health care - Territorial Clinical Hospital
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Kirov City Clinical Hospital #1; Neurology Department
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
City
Nizniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Perm SMA n.a. academ. E.A. Vagner
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
City Clinical Hospital#2
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Saratov State Medical University of RosZdrav; Neurology
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
Fakultna Nemocnica Roosevelta
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Vseobecna nemocnica s poliklinikou Levoca a.s.
City
Levoca
ZIP/Postal Code
054 01
Country
Slovakia
Facility Name
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska Sjukhuset; Neurology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna Neurology
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Haseki Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul Bilim Universty Medical Fac.
City
Istanbul
ZIP/Postal Code
34394
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
City Clinical Hospital #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Road Clinical Hospital of Donetsk Station; Neurology Department
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Regional Clinical Hospital; Neurology Department
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Kings College Hospital; Neurosciences Clinical Trials Office
City
London
ZIP/Postal Code
SE5 9NT
Country
United Kingdom
Facility Name
City General Hospital; Department of Neurology
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35672926
Citation
Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.
Results Reference
derived
PubMed Identifier
34904871
Citation
Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.
Results Reference
derived
PubMed Identifier
33724637
Citation
Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.
Results Reference
derived
PubMed Identifier
32690791
Citation
Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.
Results Reference
derived
PubMed Identifier
32511687
Citation
Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.
Results Reference
derived
PubMed Identifier
28002679
Citation
Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
Results Reference
derived

Learn more about this trial

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

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