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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 participants with EDSS 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 (e.g., 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

  • 21st Century Neurology
  • Mercy Medical Group
  • Scripps Clinic
  • MS Center of California
  • Southern California Permanente Medical Group
  • Neuro-Therapeutics Inc.
  • University of California at San Francisco
  • Health First Physicians Inc.
  • Mercy Research Institute
  • Miami Research Associates
  • Axiom Clinical Research of Florida
  • University of South Florida
  • Shepherd Center Inc.
  • Emory University; Department of Neurology
  • NeuroTrials Research, Inc.
  • Northwestern University; Dept. of Neurology
  • Consultants in Neurology Ltd
  • American Health Network Institute, LLC
  • Massachusetts General Hospital.
  • Michigan Neurology Associates P.C.
  • Michigan Institute for Neurological Disorders
  • The Minneapolis Clinic of Neurology
  • Washington University; Wash Uni. Sch. Of Med
  • The MS Center for Innovations In Care
  • University of Nebraska Medical Center
  • University of New Mexico
  • The MS Center; Advance Neurology and Pain
  • Atrium Health Neurosciences Institute ? Charlotte
  • OnSite Clinical Solutions LLC
  • Neurology Associates PA
  • University Neurology Inc.
  • The Ohio State University Wexner Medical Center
  • Oklahoma Medical Research Foundation
  • Providence Neurological Specialties
  • Albert Einstein Medical Center; Depatment of Neurosensory sciences
  • Magee-Woman's Hospital
  • Uni of Texas Health Science Center At Houston
  • Bhupesh Dihenia M.D. P.A.
  • Uni of Vermont Medical Center;
  • Multicare Research Institute; Multicare Neuroscience Center of Washington
  • Instituto centenario
  • Hospital Español
  • Fundacion Rosarina de Neurorehabilitacion
  • Royal North Shore Hospital; Department of Neurology
  • Barmherzige Brueder Konventspital
  • AZ Sint Jan
  • Cliniques Universitaires Saint-Luc; Neurology
  • AZ Delta (Campus Rumbeke)
  • Hospital das Clinicas - UFG;Reumatologia
  • IMV Pesquisa Neurológica
  • Clinica Neurologica; Neurocirurgica de Joinville
  • MHAT Avis Medica; Neurology Department
  • First MHAT; Clinic of Neurology
  • MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders
  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
  • Military Medical Academy; Neurology
  • Hospital Carlos Van Buren
  • Fakultni nemocnice u sv. Anny; Neurologicka klinika
  • Fakultni nemocnice Hradec Kralove
  • Nemocnice Jihlava; NEU-Neurologicke oddeleni
  • Krajska Nemocnice Pardubice Neurologicka Klinika
  • VFN Praha Poliklinika Rs Centrum - Budova A
  • Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • FinnMedi Oy
  • Groupe Hospitalier Pellegrin
  • CHU Hopital Gabriel Montpied; Service de Neurologie
  • Hopital Central; Neurologie
  • CHU de Nîmes Hopital Caremeau; Service de Neurologie
  • Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
  • Charité Universitaetsmedizin Berlin, Campus Charité Mitte
  • Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
  • Asklepiosklinik Barmbek; Abteilung Neurologie
  • Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie
  • Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
  • Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie
  • Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune
  • Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
  • Semmelweis Egyetem AOK; Neurologiai Klinika
  • Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti
  • Szent Borbala Korhaz; Neurology
  • Chaim Sheba Medical Center; Neurology Department
  • Azienda Ospedaliera Sant'Andrea
  • Irccs Ospedale San Raffaele
  • Azienda Socio Sanitaria Territoriale della Valle Olona (pres
  • Azienda Ospedaliera di Padova; Clinica Neurologica
  • Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
  • P. Stradins Clinical University Hospital; Neurology
  • Kaunas Medical University Hospital
  • Klaipeda University Hospital Public Institution
  • Vilnius University Hospital Santariskiu Clinic
  • Grupo Médico Camino S.C.
  • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
  • St. Antonius Ziekenhuis Nieuwegein
  • Policlinico Especializado en Neurologia
  • Clinica Anglo Americana
  • Hospital Nacional Dos de Mayo
  • Clinica Centenario Peruano Japonesa; Neurology
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
  • MA-LEK Clinical Sp. Z o.o.
  • Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
  • Hospital de Braga; Servico de Neurologia
  • Sverdlovsk Regional Clinical Hospital 1
  • Kemerovo Regional Clinical Hospital
  • Central Clinical Hospital #2 N.A. Semashko OAO RJHD
  • FGBU FNKC FMBA of Russia
  • FSBIH Siberian Regional Medical Centre of FMBA of Russia
  • MRC for Oncology and Neurology Biotherapy
  • Samara State Medical University
  • Reg. SI of Health Care Smolensk Regional Clinical Hospital
  • MMA of Ministry of Defense of Russia named after S.M. Kirov
  • St.-Peterburg State institution of health care City multifield hospital #2
  • Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
  • Military Medical Academy
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • FNsP Bratislava - Nemocnica Stare mesto
  • FNsP Bratislava, Nemocnica Ruzinov
  • Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren
  • Fakultna nemocnica s poliklinikou Zilina
  • Dr CC Coetzee Inc
  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
  • Hospital de Basurto
  • Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
  • Hospital Universitario Virgen Macarena
  • Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
  • Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia
  • Hopital Razi
  • Hopital Universitaire Fattouma Bourguiba
  • Hopital Charles Nicolle
  • MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics
  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
  • Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology
  • Lviv Regional Clinical Hospital; Department of Neurology
  • 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
  • Royal London Hospital; Neurology

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 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. 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.
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
November 23, 2010
Last Updated
March 2, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01247324
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
August 31, 2011 (Actual)
Primary Completion Date
April 2, 2015 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
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). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

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
821 (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 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. 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 108
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 108
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.
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 participants with EDSS 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 (e.g., 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
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mercy Medical Group
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
MS Center of California
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Neuro-Therapeutics Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Health First Physicians Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Mercy Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Shepherd Center Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University; Department of Neurology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University; Dept. of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Consultants in Neurology Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2114
Country
United States
Facility Name
Michigan Neurology Associates P.C.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48035
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
The Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The MS Center for Innovations In Care
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-0600
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
The MS Center; Advance Neurology and Pain
City
Advance
State/Province
North Carolina
ZIP/Postal Code
27006
Country
United States
Facility Name
Atrium Health Neurosciences Institute ? Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
OnSite Clinical Solutions LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Neurology Associates PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
University Neurology Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Neurological Specialties
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Albert Einstein Medical Center; Depatment of Neurosensory sciences
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Magee-Woman's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Uni of Texas Health Science Center At Houston
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
Uni of Vermont Medical Center;
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Multicare Research Institute; Multicare Neuroscience Center of Washington
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Instituto centenario
City
Buenos Aires
ZIP/Postal Code
C1204AAD
Country
Argentina
Facility Name
Hospital Español
City
Ciudad Autonoma Bs As
ZIP/Postal Code
C1209AAB
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
ZIP/Postal Code
S2000BZL
Country
Argentina
Facility Name
Royal North Shore Hospital; Department of Neurology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Barmherzige Brueder Konventspital
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
AZ Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc; Neurology
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospital das Clinicas - UFG;Reumatologia
City
Goiania
State/Province
GO
ZIP/Postal Code
74653-050
Country
Brazil
Facility Name
IMV Pesquisa Neurológica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Facility Name
Clinica Neurologica; Neurocirurgica de Joinville
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
MHAT Avis Medica; Neurology Department
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
First MHAT; Clinic of Neurology
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders
City
Sofia
ZIP/Postal Code
1113
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
Military Medical Academy; Neurology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Hospital Carlos Van Buren
City
Valparaiso
ZIP/Postal Code
2340000
Country
Chile
Facility Name
Fakultni nemocnice u sv. Anny; Neurologicka klinika
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava; NEU-Neurologicke oddeleni
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Krajska Nemocnice Pardubice Neurologicka Klinika
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
VFN Praha Poliklinika Rs Centrum - Budova A
City
Prague
ZIP/Postal Code
12808
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
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
FinnMedi Oy
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Hopital Gabriel Montpied; Service de Neurologie
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Central; Neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CHU de Nîmes Hopital Caremeau; Service de Neurologie
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Charité Universitaetsmedizin Berlin, Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Asklepiosklinik Barmbek; Abteilung Neurologie
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Facility Name
Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie
City
Oldenburg
ZIP/Postal Code
26122
Country
Germany
Facility Name
Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune
City
Prien
ZIP/Postal Code
83209
Country
Germany
Facility Name
Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Semmelweis Egyetem AOK; Neurologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Szent Borbala Korhaz; Neurology
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Chaim Sheba Medical Center; Neurology Department
City
Ramat-Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
City
Gallarate
State/Province
Valle D?Aosta
ZIP/Postal Code
21013
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Clinica Neurologica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
City
Riga
ZIP/Postal Code
1015
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital; Neurology
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital Public Institution
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Grupo Médico Camino S.C.
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03600
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Policlinico Especializado en Neurologia
City
Callao
ZIP/Postal Code
04
Country
Peru
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo
City
Lima
Country
Peru
Facility Name
Clinica Centenario Peruano Japonesa; Neurology
City
Pueblo Libre
ZIP/Postal Code
Lima 21
Country
Peru
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
City
Katowice
ZIP/Postal Code
40-588
Country
Poland
Facility Name
MA-LEK Clinical Sp. Z o.o.
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Hospital de Braga; Servico de Neurologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Sverdlovsk Regional Clinical Hospital 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
FGBU FNKC FMBA of Russia
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
FSBIH Siberian Regional Medical Centre of FMBA of Russia
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
MRC for Oncology and Neurology Biotherapy
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Facility Name
Samara State Medical University
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Reg. SI of Health Care Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
MMA of Ministry of Defense of Russia named after S.M. Kirov
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St.-Peterburg State institution of health care City multifield hospital #2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis
City
NIS
ZIP/Postal Code
18000
Country
Serbia
Facility Name
FNsP Bratislava - Nemocnica Stare mesto
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
FNsP Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Dr CC Coetzee Inc
City
Durban
ZIP/Postal Code
4319
Country
South Africa
Facility Name
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
City
Santa Cruz De Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Hopital Razi
City
Mannouba
ZIP/Postal Code
2010
Country
Tunisia
Facility Name
Hopital Universitaire Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Hopital Charles Nicolle
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital; Department of Neurology
City
Lviv
ZIP/Postal Code
79010
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
Royal London Hospital; Neurology
City
London
ZIP/Postal Code
E1 1BD
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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