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A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (O'HAND)

Primary Purpose

Multiple Sclerosis, Primary Progressive

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocrelizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Primary Progressive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • EDSS score at screening and baseline >= 3.0 to 8.0, inclusive
  • Disease duration from the onset of MS symptoms relative to randomization date:

Less than 20 years in patients with an EDSS score at screening 7.0 - 8.0 Less than 15 years in patients with an EDSS at screening 5.5 - 6.5 Less than 10 years in patients with an EDSS at screening <= 5.0

  • Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated IgG index or one or more IgG oligoclonal bands detected by isoelectric focusing
  • Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)
  • Neurological stability for ≥ 30 days prior to baseline
  • Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
  • Neurological stability for >/= 30 days prior to baseline
  • Patients previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

Exclusion Criteria:

  • History of relapsing-remitting or secondary progressive MS at screening
  • Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease
  • Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML)
  • Known active malignancy or are being actively monitored for recurrence of malignancy
  • Immunocompromised state
  • Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
  • Inability to complete an MRI or contraindication to Gd administration.
  • Patients requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Patients must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization.
  • Contraindications to mandatory premedications for infusion-related reactions, including:

uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines

  • Known presence of other neurologic disorders
  • Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug
  • Lack of peripheral venous access
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of alcohol or other drug abuse
  • History of primary or secondary immunodeficiency
  • Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
  • Previous treatment with B-cell targeting therapies
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Any previous history of transplantation or anti-rejection therapy
  • Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • Positive serum hCG measured at screening or positive urine β-hCG at baseline
  • Positive screening tests for hepatitis B
  • Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
  • Lack of MRI activity at screening/baseline if more than 650 patients without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 patients with MRI activity will be randomized

Eligibility Criteria for Open-Label Extension Phase:

  • Completed the double-blind treatment phase of the trial or have received PDP OCR in the FU1 phase, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Patients who withdrew from study treatment and received another disease-modifying therapy (DMT) or commercial ocrelizumab will not be allowed to enter in the OLE phase.
  • Meet the re-treatment criteria for ocrelizumab
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

Sites / Locations

  • HonorHealth Neurology
  • Multiple Sclerosis Center of CaliforniaRecruiting
  • SC3 Research Group, IncRecruiting
  • Georgetown University Medical CenterRecruiting
  • SFM Clinical Research, LLCRecruiting
  • MS and Neuromuscular Center of Excellence
  • Neurological Services of Orlando
  • Vero NeurologyRecruiting
  • University of Kansas Medical CenterRecruiting
  • Michigan Neurology Associates P.C.
  • Henry Ford HospitalRecruiting
  • University of Nebraska Medical Center
  • Dent Neurological Institute
  • The Boster Center for MSRecruiting
  • Columbus Neuroscience
  • Thomas Jefferson UniversityRecruiting
  • Albert Einstein Medical Center
  • Premier Neurology
  • Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
  • Meridian Clinical Research
  • Center for Neurological DisordersRecruiting
  • Brain and Mind Research InstituteRecruiting
  • John Hunter Hospital
  • Austin HospitalRecruiting
  • Royal Melbourne HospitalRecruiting
  • Kepler Universitatsklinikum Linz
  • Cliniques Universitaires St-LucRecruiting
  • UZ Antwerpen PINRecruiting
  • CHU Tivoli
  • MS & Neurologisch Revalidatie CentrumRecruiting
  • Military Medical Academy HBATRecruiting
  • Multiprofile Hospital For Active Treatment Avis MedicaRecruiting
  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EADRecruiting
  • University of Alberta
  • Dalhousie Multiple Sclerosis Research UnitRecruiting
  • London Health Sciences Centre
  • Ottawa HospitalRecruiting
  • University of TorontoRecruiting
  • Clinique Neuro Outaouais
  • Recherche Sepmus Inc.
  • Clinica Colsanitas S.A. sede Clinica Universitaria ColombiaRecruiting
  • Instituto Neurologico de Colombia INDECRecruiting
  • Clinical Hospital Centre OsijekRecruiting
  • General Hospital VarazdinRecruiting
  • Clinical Hospital Sestre MilosrdniceRecruiting
  • University Hospital Center ZagrebRecruiting
  • Ain Shams University Hospital
  • CHU Amiens Hopital Sud; NeurologieRecruiting
  • Centre Hospitalier Universitaire de Bordeaux Hopital PellegrinRecruiting
  • Hopital Pierre WertheimerRecruiting
  • Centre Hospitalier Universitaire de Clermont FerrandRecruiting
  • Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie
  • Hopitaux de La TimoneRecruiting
  • CHU Gui de ChauliacRecruiting
  • CHRU NancyRecruiting
  • Hopital Guillaume Et Rene LaennecRecruiting
  • CHU de Nimes - Hopital Universitaire CaremeauRecruiting
  • Hopital CivilRecruiting
  • Pineo Medical Ecosystem LTDRecruiting
  • Tbilisi State Medical UniversityRecruiting
  • Khechinashvili University HospitalRecruiting
  • Medizinische Hochschule Hannover
  • Bacs-Kiskun Megyei Korhaz
  • Szent Borbala Korhaz
  • Saint Vincent's University Hospital
  • AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2Recruiting
  • Fondazione PTV Policlinico Tor VergataRecruiting
  • Azienda Ospedaliera Sant'andreaRecruiting
  • Ospedale Policlinico San MartinoRecruiting
  • Ospedale San Raffaele S.r.l. - PPDSRecruiting
  • Fondazione Istituto Neurologico Mondino IRCCSRecruiting
  • Azienda Sanitaria Ospedaliera S Luigi GonzagaRecruiting
  • Fondazione Istituto G. Giglio di CefaluRecruiting
  • Saint George University Medical HospitalRecruiting
  • American University of Beirut - Medical CenterRecruiting
  • Hotel Dieu de FranceRecruiting
  • Grupo Medico CaminoRecruiting
  • Centro de Diagnostico Neurofisiologico S.C
  • Unidad de Investigacion en Salud de ChihuahuaRecruiting
  • Clinical Research InstituteRecruiting
  • Neurociencias Estudios Clinicos S.C.Recruiting
  • Scientia Investigacion Clinica S.C.
  • Hospital Angeles ChihuahuaRecruiting
  • Instituto de Investigationes Clinicas para la Salud ACRecruiting
  • Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX
  • CHU Mohammed VIRecruiting
  • Centre Hospitalier Ibn Sina CHIS - Hopital des SpecialitesRecruiting
  • Hopital Militaire d'Instruction Mohamed VRecruiting
  • New Zealand Clinical Research - ChristchurchRecruiting
  • Dunedin HospitalRecruiting
  • Waikato Hospital; NeurologyRecruiting
  • Wellington HospitalRecruiting
  • Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24aRecruiting
  • Neurocentrum Bydgoszcz sp z o.oRecruiting
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? NeurologicznyRecruiting
  • Mazowieckie Centrum Badan KlinicznychRecruiting
  • Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw OchudloRecruiting
  • M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SMRecruiting
  • Novo-Med Zielinski i wspolnicy Sp. j.Recruiting
  • Neuro-Medic Janusz ZbrojkiewiczRecruiting
  • RESMEDICA Spolka z o.o.Recruiting
  • SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki NeurologiiRecruiting
  • Centrum Neurologii Krzysztof SelmajRecruiting
  • Prywatny Gabinet Lekarski Urszula Chyrchel-PaszkiewiczRecruiting
  • Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad RejdakRecruiting
  • Wojewodzki Szpital SpecjalistycznyRecruiting
  • EMC Instytut Medyczny SARecruiting
  • Clinical Research Center Sp z o oRecruiting
  • Wojewódzki Szpital Specjalistyczny Nr 3Recruiting
  • Centrum Medyczne MedykRecruiting
  • EUROMEDIS Sp z o oRecruiting
  • Centrum Medyczne NeuroProtect Zablocinska 10Recruiting
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Hospital Garcia de OrtaRecruiting
  • Hospital de BragaRecruiting
  • Hospital Beatriz AngeloRecruiting
  • Hospital de Santo AntonioRecruiting
  • Campus Neurologico SeniorRecruiting
  • Colentina Clinical Hospital
  • Emergency University Hospital
  • SC Clubul Sanatatii SRLRecruiting
  • County Hospital CaracalRecruiting
  • Cai Ferate Clinical HospitalRecruiting
  • Spitalul Municipal Dr.Alexandru Simionescu HunedoaraRecruiting
  • Targu Mures Clinical Emergency County HospitalRecruiting
  • State Healthcare Institution Territorial Clinical Hospital
  • Kuvatov Republican Clinical Hospital
  • Krasnoyarsk State Medical AcademyRecruiting
  • Research Center of Neurology of RAMSRecruiting
  • City Clinical Hospital #24Recruiting
  • Moscow Regional Research Clinical Institute Na MfvladimirskiyRecruiting
  • City Out Patient Clinic For Rehabilitation Treatment #7
  • City Clinical Hospital #15 n.a. N.F. Filatov
  • Neftyanik Medical and Sanitary UnitRecruiting
  • City Clinical Hospital #12Recruiting
  • Nizhegorodskaya Regional Clinical Hospital n.a. SemashkoRecruiting
  • MEDIS Limited Liability CompanyRecruiting
  • City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31Recruiting
  • City Hospital #40 of Kurortniy Administrative DistrictRecruiting
  • Yaroslavl Clinical Hospital #8
  • City Clinical Hospital #4Recruiting
  • Sverdlovsk Regional Clinical Hospital 1Recruiting
  • Vertebronevrologiya LLCRecruiting
  • Ulyanovsk Regional Clinical HospitalRecruiting
  • Belgorod Regional Clinical Hospital
  • Kemerovo Regional Clinical HospitalRecruiting
  • Kirov State Medical AcademyRecruiting
  • SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology departmentRecruiting
  • FSBIH Siberian Regional Medical Centre of FMBA of RussiaRecruiting
  • Perm SMA n.a. academ. E.A. VagnerRecruiting
  • Siberian State Medical University of Roszdrav
  • Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
  • Clinical Center of SerbiaRecruiting
  • Military Medical AcademyRecruiting
  • Clinical Center KragujevacRecruiting
  • Clinical Center Nis
  • Clinical Centre of VojvodinaRecruiting
  • General Hospital UziceRecruiting
  • Clinical Hospital Centre ZemunRecruiting
  • Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
  • Hospital Universitario Quironsalud MadridRecruiting
  • Complejo Hospitalario Universitario de VigoRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Cruces
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital General de Castellon
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario HM Sanchinarro-CIOCC
  • Hospital Regional Universitario Carlos HayaRecruiting
  • Hospital Universitario Virgen de La ArrixacaRecruiting
  • Complejo Asistencial Universitario de Salamanca ? H. ClinicoRecruiting
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Hopital RaziRecruiting
  • Fattouma Bourguiba University HospitalRecruiting
  • Hospital Habib BourguibaRecruiting
  • Military Hospital of TunisRecruiting
  • Medical Center Dopomoga PlusRecruiting
  • Medical Centre of PE First Private ClinicRecruiting
  • LLC Medical Center INET 09Recruiting
  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional CouncilRecruiting
  • Zaporizhia City Multispecialty Clinical Hospital #9Recruiting
  • Separated structural unit ?University clinic? of Dnipro State Medical UniversityRecruiting
  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical HospitalRecruiting
  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical HospitalRecruiting
  • LLC Medical Center Family Medicine ClinicRecruiting
  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. KarabeleshRecruiting
  • Treatment and Diagnostic Center of LLC MRT ElitRecruiting
  • Medical Center of LLC Medical Clinic BlagomedRecruiting
  • Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv CityRecruiting
  • LLC Smart Medical CenterRecruiting
  • Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RCRecruiting
  • Medical Clinical Research Center of Medical Center LLC Health Clinic; Department of General TherapyRecruiting
  • Medical Center SalutemRecruiting
  • Treatment and diagnostic Center Neuro Global of LLC Neuro GlobalRecruiting
  • Kyiv City Clinical Hospital #4Recruiting
  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Volyn Regional Clinical HospitalRecruiting
  • University Hospital of WalesRecruiting
  • Queen Elizabeth University Hospital - PPDSRecruiting
  • Raigmore Hospital - PPDS; Highland Clinical Research Facility Center For Health ScienceRecruiting
  • Walton Centre For Neurology and Neurosurgery
  • The Royal London HospitalRecruiting
  • The National Hospital for Neurology & Neurosurgery
  • University of NottinghamRecruiting
  • Peninsula College of Medicine and DentistryRecruiting
  • Salford Royal HospitalRecruiting
  • Royal Hallamshire HospitalRecruiting
  • Morriston HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ocrelizumab

Placebo

Arm Description

Participants will receive ocrelizumab by IV infusion every 24 weeks.

Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.

Outcomes

Primary Outcome Measures

Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks
20% increase from baseline in Nine-Hole Peg Test (9-HPT) confirmed for at least 12 weeks.

Secondary Outcome Measures

Time to Upper Limb Disability Progression Confirmed For at Least 24 Weeks
20% increases from baseline in 9-HPT confirmed for at least 24 weeks.
Time to Disability Progression Confirmed For at Least 12 Weeks
Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.
Time to Disability Progression Confirmed For at Least 24 Weeks
Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.
Percent Change in Total Volume of T2 Lesions on MRI
Percent Change in Total Brain Volume on MRI Scans
Percentage of Participants with Adverse Events
Percentage of Participants With Serious Adverse Events
Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab
Evaluation of Ocrelizumab Pharmacodynamics, as measured by B-Cell Levels in Blood

Full Information

First Posted
July 17, 2019
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04035005
Brief Title
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Acronym
O'HAND
Official Title
A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
December 10, 2027 (Anticipated)
Study Completion Date
November 11, 2030 (Anticipated)

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 study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).
Detailed Description
The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 120 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. In the FU1 phase, all participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants who receive post-double progression ocrelizumab (PDP OCR) treatment, other immunomodulatory or immunosuppressive treatment(s) for MS, commercial ocrelizumab, or no treatment. The FU1 phase will run in parallel with the double-blind treatment phase until the primary analysis is performed. If the primary analysis is positive, an optional OLE phase is planned for eligible participants who either have remained in the double-blind treatment phase or are on PDP OCR treatment at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The follow-up 2 (FU2) phase will begin after the primary analysis is performed. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 and not on PDP OCR treatment at the time of primary analysis; participants who are ongoing in the double-blind treatment phase or receiving PDP OCR at the time of the primary analysis and do not enter the OLE phase; participants who complete or withdraw from the OLE phase. At the end of the FU2, all participants will move into B-cell monitoring (BCM) phase until the end of the study. This study will end when all participants who are not being treated with an alternative B-cell depleting therapy have repleted his or her B-cells.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Participants will receive ocrelizumab by IV infusion every 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
Ocrevus
Intervention Description
The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.
Primary Outcome Measure Information:
Title
Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks
Description
20% increase from baseline in Nine-Hole Peg Test (9-HPT) confirmed for at least 12 weeks.
Time Frame
Baseline up to approximately 5.5 years
Secondary Outcome Measure Information:
Title
Time to Upper Limb Disability Progression Confirmed For at Least 24 Weeks
Description
20% increases from baseline in 9-HPT confirmed for at least 24 weeks.
Time Frame
Baseline up to approximately 5.5 years
Title
Time to Disability Progression Confirmed For at Least 12 Weeks
Description
Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.
Time Frame
Baseline up to approximately 5.5 years
Title
Time to Disability Progression Confirmed For at Least 24 Weeks
Description
Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.
Time Frame
Baseline up to approximately 5.5 years
Title
Percent Change in Total Volume of T2 Lesions on MRI
Time Frame
Baseline up to week 120
Title
Percent Change in Total Brain Volume on MRI Scans
Time Frame
Week 24 to Week 120
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline up to 8.5 years
Title
Percentage of Participants With Serious Adverse Events
Time Frame
Baseline up to 8.5 years
Title
Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab
Time Frame
Baseline, Weeks 2, 12, 24, 48, 60, 72, and every 12 weeks till the end of the double-blind period and Weeks 0 and 48 of the OLE period
Title
Evaluation of Ocrelizumab Pharmacodynamics, as measured by B-Cell Levels in Blood
Time Frame
Baseline, Weeks 2, 24, 48, 72 and every 12 weeks till the end of the double-blind period and Weeks 0, 22, 46, 70 and 96 of the OLE period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: EDSS score at screening and baseline >= 3.0 to 8.0, inclusive Disease duration from the onset of MS symptoms relative to randomization date: Less than 20 years in patients with an EDSS score at screening 7.0 - 8.0 Less than 15 years in patients with an EDSS at screening 5.5 - 6.5 Less than 10 years in patients with an EDSS at screening <= 5.0 Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated IgG index or one or more IgG oligoclonal bands detected by isoelectric focusing Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands) Neurological stability for ≥ 30 days prior to baseline Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline Neurological stability for >/= 30 days prior to baseline Patients previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required. For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile Exclusion Criteria: History of relapsing-remitting or secondary progressive MS at screening Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML) Known active malignancy or are being actively monitored for recurrence of malignancy Immunocompromised state Receipt of a live-attenuated vaccine within 6 weeks prior to randomization Inability to complete an MRI or contraindication to Gd administration. Patients requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Patients must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization. Contraindications to mandatory premedications for infusion-related reactions, including: uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines Known presence of other neurologic disorders Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug Lack of peripheral venous access Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study History of alcohol or other drug abuse History of primary or secondary immunodeficiency Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS Previous treatment with B-cell targeting therapies Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation Any previous history of transplantation or anti-rejection therapy Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization Systemic corticosteroid therapy within 4 weeks prior to screening Positive serum hCG measured at screening or positive urine β-hCG at baseline Positive screening tests for hepatitis B Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above Lack of MRI activity at screening/baseline if more than 650 patients without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 patients with MRI activity will be randomized Eligibility Criteria for Open-Label Extension Phase: Completed the double-blind treatment phase of the trial or have received PDP OCR in the FU1 phase, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Patients who withdrew from study treatment and received another disease-modifying therapy (DMT) or commercial ocrelizumab will not be allowed to enter in the OLE phase. Meet the re-treatment criteria for ocrelizumab For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required. For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WA40404 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
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
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Withdrawn
Facility Name
Multiple Sclerosis Center of California
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
SC3 Research Group, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
SFM Clinical Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Name
MS and Neuromuscular Center of Excellence
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
Vero Neurology
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Neurology Associates P.C.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48035
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-0600
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Boster Center for MS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Neuroscience
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43801
Country
United States
Individual Site Status
Completed
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Withdrawn
Facility Name
Premier Neurology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Withdrawn
Facility Name
Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Meridian Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Withdrawn
Facility Name
Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Name
Brain and Mind Research Institute
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Kepler Universitatsklinikum Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen PIN
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
MS & Neurologisch Revalidatie Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Military Medical Academy HBAT
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital For Active Treatment Avis Medica
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Completed
Facility Name
Dalhousie Multiple Sclerosis Research Unit
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique Neuro Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
City
Bogota, D.C.
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Instituto Neurologico de Colombia INDEC
City
Medellin
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
CHU Amiens Hopital Sud; Neurologie
City
Amiens Cedex1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pierre Wertheimer
City
Cedex
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Clermont Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopitaux de La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Guillaume Et Rene Laennec
City
Nantes
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nimes - Hopital Universitaire Caremeau
City
Nimes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Pineo Medical Ecosystem LTD
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi State Medical University
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Szent Borbala Korhaz
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Saint Vincent's University Hospital
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Individual Site Status
Withdrawn
Facility Name
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Rome
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant'andrea
City
Rome
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele S.r.l. - PPDS
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto Neurologico Mondino IRCCS
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto G. Giglio di Cefalu
City
Cefalù
State/Province
Sicilia
ZIP/Postal Code
90015
Country
Italy
Individual Site Status
Recruiting
Facility Name
Saint George University Medical Hospital
City
Achrafieh
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
American University of Beirut - Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Hotel Dieu de France
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Grupo Medico Camino
City
DF
State/Province
Mexico CITY (federal District)
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Diagnostico Neurofisiologico S.C
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
01600
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Unidad de Investigacion en Salud de Chihuahua
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14390
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute
City
Tlalnepantla de Baz
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Scientia Investigacion Clinica S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Hospital Angeles Chihuahua
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Investigationes Clinicas para la Salud AC
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX
City
Monterrey
ZIP/Postal Code
64050
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
CHU Mohammed VI
City
Marrakech
ZIP/Postal Code
40080
Country
Morocco
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
City
Rabat
ZIP/Postal Code
10100
Country
Morocco
Individual Site Status
Recruiting
Facility Name
Hopital Militaire d'Instruction Mohamed V
City
Rabat
ZIP/Postal Code
10100
Country
Morocco
Individual Site Status
Recruiting
Facility Name
New Zealand Clinical Research - Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Waikato Hospital; Neurology
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a
City
Bia?ystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocentrum Bydgoszcz sp z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowieckie Centrum Badan Klinicznych
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo
City
Katowice
ZIP/Postal Code
40-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novo-Med Zielinski i wspolnicy Sp. j.
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neuro-Medic Janusz Zbrojkiewicz
City
Katowice
ZIP/Postal Code
40-686
Country
Poland
Individual Site Status
Recruiting
Facility Name
RESMEDICA Spolka z o.o.
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki Neurologii
City
Kraków
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Individual Site Status
Recruiting
Facility Name
Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Recruiting
Facility Name
Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak
City
Lublin
ZIP/Postal Code
20-605
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Recruiting
Facility Name
EMC Instytut Medyczny SA
City
Pozna?
ZIP/Postal Code
60-309
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Sp z o o
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewódzki Szpital Specjalistyczny Nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
EUROMEDIS Sp z o o
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne NeuroProtect Zablocinska 10
City
Warsaw
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-915
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Emergency University Hospital
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Withdrawn
Facility Name
SC Clubul Sanatatii SRL
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Individual Site Status
Recruiting
Facility Name
County Hospital Caracal
City
Caracal
ZIP/Postal Code
235200
Country
Romania
Individual Site Status
Recruiting
Facility Name
Cai Ferate Clinical Hospital
City
Constan?a
ZIP/Postal Code
900123
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Municipal Dr.Alexandru Simionescu Hunedoara
City
Hunedoara
ZIP/Postal Code
331057
Country
Romania
Individual Site Status
Recruiting
Facility Name
Targu Mures Clinical Emergency County Hospital
City
Targu Mures
ZIP/Postal Code
540100
Country
Romania
Individual Site Status
Recruiting
Facility Name
State Healthcare Institution Territorial Clinical Hospital
City
Barnaul
State/Province
Altaj
ZIP/Postal Code
656024
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Kuvatov Republican Clinical Hospital
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Research Center of Neurology of RAMS
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Clinical Hospital #24
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
127015
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Moscow Regional Research Clinical Institute Na Mfvladimirskiy
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Out Patient Clinic For Rehabilitation Treatment #7
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105005
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
City Clinical Hospital #15 n.a. N.F. Filatov
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111539
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Neftyanik Medical and Sanitary Unit
City
Tumen
State/Province
Moskovskaja Oblast
ZIP/Postal Code
625000
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Clinical Hospital #12
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603003
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
MEDIS Limited Liability Company
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603137
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
City Hospital #40 of Kurortniy Administrative District
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Yaroslavl Clinical Hospital #8
City
Yaroslavl
State/Province
Sankt Petersburg
ZIP/Postal Code
150030
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
City Clinical Hospital #4
City
Saransk
State/Province
Saratov
ZIP/Postal Code
430032
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Sverdlovsk Regional Clinical Hospital 1
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Vertebronevrologiya LLC
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420047
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
State/Province
Uljanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Belgorod Regional Clinical Hospital
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Kirov State Medical Academy
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
City
Nizniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
FSBIH Siberian Regional Medical Centre of FMBA of Russia
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Perm SMA n.a. academ. E.A. Vagner
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Siberian State Medical University of Roszdrav
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
City
Tver
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Nis
City
NIS
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
Clinical Centre of Vojvodina
City
Nova Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
General Hospital Uzice
City
Uzice
ZIP/Postal Code
31000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centre Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Castellon
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro-CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Regional Universitario Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Asistencial Universitario de Salamanca ? H. Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hopital Razi
City
Mannouba
ZIP/Postal Code
2010
Country
Tunisia
Individual Site Status
Recruiting
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Name
Hospital Habib Bourguiba
City
Sfax
ZIP/Postal Code
3029
Country
Tunisia
Individual Site Status
Recruiting
Facility Name
Military Hospital of Tunis
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Individual Site Status
Recruiting
Facility Name
Medical Center Dopomoga Plus
City
Kyiv
State/Province
Chernihiv Governorate
ZIP/Postal Code
02123
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Centre of PE First Private Clinic
City
Zhytomir
State/Province
Crimean Regional Governmenta
ZIP/Postal Code
10008
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
LLC Medical Center INET 09
City
Zaporizhzhia
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69035
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
City
Zaporizhzhia
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Zaporizhia City Multispecialty Clinical Hospital #9
City
Zaporizhzhye
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69063
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Separated structural unit ?University clinic? of Dnipro State Medical University
City
Dnipro
State/Province
Kharkiv Governorate
ZIP/Postal Code
49038
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61058
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
City
Lviv
State/Province
Kharkiv Governorate
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
LLC Medical Center Family Medicine Clinic
City
Dnipro
State/Province
Kherson Governorate
ZIP/Postal Code
49600
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
City
Kherson
State/Province
Kherson Governorate
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Treatment and Diagnostic Center of LLC MRT Elit
City
Kropyvnytskyi
State/Province
KIEV Governorate
ZIP/Postal Code
25005
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Center of LLC Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01001
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv City
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
LLC Smart Medical Center
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04212
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RC
City
Uzhhorod
State/Province
KIEV Governorate
ZIP/Postal Code
88018
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic; Department of General Therapy
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21009
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Center Salutem
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21050
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Treatment and diagnostic Center Neuro Global of LLC Neuro Global
City
Krykhivtsi
State/Province
Polissya Okruha
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Kyiv City Clinical Hospital #4
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital - PPDS
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Raigmore Hospital - PPDS; Highland Clinical Research Facility Center For Health Science
City
Inverness
ZIP/Postal Code
IV2 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Walton Centre For Neurology and Neurosurgery
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Peninsula College of Medicine and Dentistry
City
Plymouth
ZIP/Postal Code
PL6 8BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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

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