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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

Primary Purpose

Multiple Sclerosis

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

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis (PPMS).
  • Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive.
  • Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
  • Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds
  • Score of >/= to 2.0 on the Functional Systems scale for the pyramidal system that was due to lower extremity findings at screening and baseline.
  • Documented MRI of brain with abnormalities consistent with MS
  • Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
  • Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
  • Disease duration from the onset of MS symptoms; if EDSS score at screening is less or equal to 5, disease duration must be less than 10 years; If EDSS score at screening is more than 5, disease duration must be less than 15 years
  • Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands.
  • For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
  • For female participants without reproductive potential, may be enrolled if post-menopausal unless receiving a hormonal therapy for her menopause or if surgically sterile.

Exclusion Criteria:

  • History of relapsing remitting or secondary progressive MS at screening.
  • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
  • History of confirmed or suspected progressive multifocal leukoencephalopathy.
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
  • Immunocompromised state.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
  • Inability to complete an MRI or contraindication to gadolinium administration.
  • Contraindications to mandatory pre-medications for IRRs.
  • Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study.
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  • Significant, uncontrolled disease that may preclude participant from participating in the study.
  • History of or currently active primary or secondary, non-drug-related, immunodeficiency.
  • Pregnant or breastfeeding or intending to become pregnant.
  • Lack of peripheral venous access.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Treatment with any investigational agent or treatment with any experimental procedure for MS.
  • Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
  • Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
  • Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
  • Previous treatment with natalizumab within 4.5 months of baseline
  • Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
  • Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication.
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
  • Any previous history of transplantation or anti-rejection therapy.
  • Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
  • Systemic corticosteroid therapy within 4 weeks prior to screening.
  • Positive screening tests for active, latent, or inadequately treated hepatitis B
  • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.
  • Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.

Sites / Locations

  • Alabama Neurology Associates
  • 21st Century Neurology
  • University of California Irvine
  • Stanford University Medical Center; Stanford Neuroscience Health Center
  • University of Colorado Denver
  • Advanced Neurosciences Research LLC
  • MS and Neuromuscular Center of Excellence
  • University of South Florida
  • Baptist Health Lexington
  • International Neurorehabilitation Institute
  • Massachusetts General Hospital.
  • University of Massachusetts Medical School
  • Michigan Institute for Neurological Disorders
  • Washington University School of Medicine
  • Jersey Shore University Medical Centre
  • Northwell Health
  • Lenox Hill Hospital
  • Cleveland Clinic
  • Neurology Clinic PC
  • New Orleans Center for Clinical Research
  • Advanced Neurosciences Institute
  • University of Texas Southwestern Medical Center
  • Neurology Center of San Antonio
  • Texas Institute for Neurological Disorders
  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • CEMIC Saavedra
  • INECO; Neurociencias
  • Revalidatie en MS Centrum
  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
  • Hospital das Clinicas - UFG
  • Instituto de Neurologia de Curitiba
  • Instituto Méderi de Pesquisa e Saúde
  • Hospital Moinhos de Vento
  • IMV Pesquisa Neurológica
  • Hospital Sao Lucas - PUCRS
  • Clinica Neurologica; Neurocirurgica de Joinville
  • Hospital das Clinicas - UNICAMP
  • Praxis Pesquisa Médica
  • CPQuali Pesquisa Clinica Ltda
  • UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
  • MHATNP Sveti Naum EAD
  • Chum Campus Notre Dame
  • MUCH - Montreal Neurological Institute & Hospital
  • Hotel-Dieu de Levis
  • Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
  • Rigshospitalet Glostrup; Neurologisk Klinik
  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
  • CHU Brest Hopital La Cavale Blanche; Neurologie
  • Hopital Cote De Nacre; Unite Neurologie Generale
  • CHU Hopital Gabriel Montpied; Service de Neurologie
  • CH St Vincent de Paul
  • Hopital Central - CHU de Nancy; Service de Neurologie
  • Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
  • Medizinische Hochschule Hannover, Klinik für Neurologie
  • Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
  • 401 Military Hospital of Athens; Neurology Department
  • Hospital Eginition; First Department of Neurology
  • University General Hospital of Larisa; Neurology Clinic
  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology
  • UNO Medical Trials Kft.
  • Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly
  • Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology
  • Kistarcsai Flor Ferenc Korhaz; Neurology and Stroke Ambulance
  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
  • AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • AOU Città della Salute e della Scienza; Neurologia 1
  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
  • Grupo Médico Camino S.C.
  • Clinstile S.A de C.V.
  • Neurociencias Prisma, A.C
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
  • Neurocentrum Bydgoszcz sp. z o.o
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • MA-LEK Clinical Sp. Z o.o.
  • Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu
  • Centrum Neurologii Krzysztof Selmaj
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • EMC Instytut Medyczny SA
  • Wojewódzki Szpital Specjalistyczny Nr 3
  • Nzoz Palomed
  • Osrodek Badan Klinicznych Euromedis
  • Centrum Medyczne NeuroProtect
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • Hospital Santo Antonio dos Capuchos; Servico de Neurologia
  • Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • Krasnoyarsk State Medical Academy
  • National Center of Social Significant Disease
  • Research Center of Neurology of RAMS
  • Federal center of brain research and neurotechnologies
  • City Clinical Hospital #24; Multipal Sclerosis department
  • N.P. Bechtereva Institute of the Human Brain
  • Leningrad Regional Clinical Hospital
  • City Hospital #40 of Kurortniy Administrative District
  • SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
  • Vertebronevrologiya LLC
  • Ulyanovsk Regional Clinical Hospital
  • Center of Cardiology and Neurology
  • Regional clinical hospital named after prof. S.V. Ochapovsky
  • FSBIH Siberian Regional Medical Centre of FMBA of Russia
  • Perm SMA n.a. academ. E.A. Vagner
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
  • Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
  • Gazi University Medical Faculty
  • Haseki Training and Research Hospital; Department of Neurology
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Sancaktepe Training and Research Hospital; Neurology
  • Selcuk University Medical Faculty; Norology department
  • Erciyes Universitesi; Pediatric Neurology
  • Kocaeli University Hospital; Department of Neurology
  • Ege Üniversitesi Tip Fakültesi
  • Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu
  • Mersin University Medical Faculty; Neurology
  • Ondokuz Mayis University School of Medicine; Neurology
  • Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
  • Medical Center Dopomoga Plus
  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
  • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
  • 5th Cherkasy City Center of Primary Health Care
  • SI USSRI of Medical and Social Problems of Disabilities of MOHU
  • Medical Center of Private Execution First Private Clinic
  • Lvivska oblasna tsentralna likarnia
  • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Sumy Regional Clinical Hospital
  • Regional Clinical Hospital; Neurology Department
  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
  • Volyn Regional Clinical Hospital
  • Charing Cross Hospital
  • National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
  • Royal Victoria Infirmary
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ocrelizumab Higher Dose

Ocrelizumab Approved Dose

Arm Description

Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Outcomes

Primary Outcome Measures

1. Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks.
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.

Secondary Outcome Measures

Time to Onset of 24-week cCDP (cCDP24)
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time to Onset of 12-week CDP (CDP12)
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time to Onset of 24-week CDP (CDP24)
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT)
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time to >/= 20% Increase in 24-week Confirmed T25FWT
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time to >/= 20% Increase in 12-week Confirmed by 9-Hole Peg Test (9-HPT)
The 9-HPT is a performance measure used to assess upper extremity (arm and hand) function. The test consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. The participant is to pick up each of the nine pegs one at a time and as quickly as possible place them in the nine holes. Once all the pegs are in the holes, the participant is to remove them again one at a time as quickly as possible and replace them into the container. The total time to complete the task is recorded.
Time to >/= 20% Increase in 24-week Confirmed by 9-HPT
The 9-HPT is a performance measure used to assess upper extremity (arm and hand) function. The test consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. The participant is to pick up each of the nine pegs one at a time and as quickly as possible place them in the nine holes. Once all the pegs are in the holes, the participant is to remove them again one at a time as quickly as possible and replace them into the container. The total time to complete the task is recorded.
Change from Baseline in the Multiple Sclerosis Impact Scale (MSIS 29) Score
The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
Change from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical scale at Week 120
Annual Rate of Percent Change from Baseline in Total Brain Volume
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT)
The SDMT is a performance measure that has demonstrated sensitivity in detecting not only the presence of cognitive impairment but also changes in cognitive functioning over time and in response to treatment. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected orally. A four-point change from baseline is typically considered clinically meaningful.
Serum Concentration of Ocrelizumab at Specified Timepoints
Change in B-cell Levels in Blood
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Levels of Neurofilament Light Chain (NfL) in Blood
Levels of Interleukin-6 (IL-6) in Blood
Levels of Blood B-cells
Levels of blood B-cells is based on a highly sensitive assay that can accurately measure below 5 B-cells per microliter in blood
Levels of Lymphocytes in Blood
Proportion of Participants with Different DNA Genotypes

Full Information

First Posted
September 9, 2020
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04548999
Brief Title
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
Official Title
A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
November 12, 2025 (Anticipated)
Study Completion Date
July 26, 2029 (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 is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.
Detailed Description
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the lower limit of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab Higher Dose
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Arm Title
Ocrelizumab Approved Dose
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
Ocrevus
Intervention Description
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
Ocrevus
Intervention Description
Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Other Intervention Name(s)
Non-Investigational Medicinal Product
Intervention Description
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Non-Investigational Medicinal Product
Intervention Description
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Primary Outcome Measure Information:
Title
1. Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks.
Description
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time Frame
Baseline up to approximately 4.3 years
Secondary Outcome Measure Information:
Title
Time to Onset of 24-week cCDP (cCDP24)
Description
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to Onset of 12-week CDP (CDP12)
Description
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to Onset of 24-week CDP (CDP24)
Description
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT)
Description
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 24-week Confirmed T25FWT
Description
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 12-week Confirmed by 9-Hole Peg Test (9-HPT)
Description
The 9-HPT is a performance measure used to assess upper extremity (arm and hand) function. The test consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. The participant is to pick up each of the nine pegs one at a time and as quickly as possible place them in the nine holes. Once all the pegs are in the holes, the participant is to remove them again one at a time as quickly as possible and replace them into the container. The total time to complete the task is recorded.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 24-week Confirmed by 9-HPT
Description
The 9-HPT is a performance measure used to assess upper extremity (arm and hand) function. The test consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. The participant is to pick up each of the nine pegs one at a time and as quickly as possible place them in the nine holes. Once all the pegs are in the holes, the participant is to remove them again one at a time as quickly as possible and replace them into the container. The total time to complete the task is recorded.
Time Frame
Baseline up to approximately 4.3 years
Title
Change from Baseline in the Multiple Sclerosis Impact Scale (MSIS 29) Score
Description
The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
Time Frame
Baseline up to approximately 4.3 years
Title
Change from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical scale at Week 120
Time Frame
Baseline, week 120
Title
Annual Rate of Percent Change from Baseline in Total Brain Volume
Time Frame
Baseline up to approximately 4.3 years
Title
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT)
Description
The SDMT is a performance measure that has demonstrated sensitivity in detecting not only the presence of cognitive impairment but also changes in cognitive functioning over time and in response to treatment. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected orally. A four-point change from baseline is typically considered clinically meaningful.
Time Frame
Baseline up to approximately 4.3 years
Title
Serum Concentration of Ocrelizumab at Specified Timepoints
Time Frame
Weeks 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Title
Change in B-cell Levels in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Time Frame
Week 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Title
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Time Frame
Week 0, 24, 48, 72, 96, 120
Title
Levels of Neurofilament Light Chain (NfL) in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Interleukin-6 (IL-6) in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Blood B-cells
Description
Levels of blood B-cells is based on a highly sensitive assay that can accurately measure below 5 B-cells per microliter in blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Lymphocytes in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants with Different DNA Genotypes
Time Frame
Week 0, 2, 12, 24, 48, 72, 96, 120

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 primary progressive multiple sclerosis (PPMS). Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive. Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds Score of >/= to 2.0 on the Functional Systems scale for the pyramidal system that was due to lower extremity findings at screening and baseline. Documented MRI of brain with abnormalities consistent with MS Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization. Participants must be neurologically stable for at least 30 days prior to randomization and baseline. Disease duration from the onset of MS symptoms; if EDSS score at screening is less or equal to 5, disease duration must be less than 10 years; If EDSS score at screening is more than 5, disease duration must be less than 15 years Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands. For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods. For female participants without reproductive potential, may be enrolled if post-menopausal unless receiving a hormonal therapy for her menopause or if surgically sterile. Exclusion Criteria: History of relapsing remitting or secondary progressive MS at screening. Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening. History of confirmed or suspected progressive multifocal leukoencephalopathy. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Immunocompromised state. Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization. Inability to complete an MRI or contraindication to gadolinium administration. Contraindications to mandatory pre-medications for IRRs. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study. Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. Significant, uncontrolled disease that may preclude participant from participating in the study. History of or currently active primary or secondary, non-drug-related, immunodeficiency. Pregnant or breastfeeding or intending to become pregnant. Lack of peripheral venous access. History of alcohol or other drug abuse within 12 months prior to screening. Treatment with any investigational agent or treatment with any experimental procedure for MS. Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy. Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline Previous treatment with natalizumab within 4.5 months of baseline Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication. Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation. Any previous history of transplantation or anti-rejection therapy. Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization. Systemic corticosteroid therapy within 4 weeks prior to screening. Positive screening tests for active, latent, or inadequately treated hepatitis B Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab. Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
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
Alabama Neurology Associates
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Stanford University Medical Center; Stanford Neuroscience Health Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Advanced Neurosciences Research LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
MS and Neuromuscular Center of Excellence
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Baptist Health Lexington
City
Nicholasville
State/Province
Kentucky
ZIP/Postal Code
40356
Country
United States
Facility Name
International Neurorehabilitation Institute
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Jersey Shore University Medical Centre
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-0001
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Texas Institute for Neurological Disorders
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Facility Name
CEMIC Saavedra
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
INECO; Neurociencias
City
Rosario
ZIP/Postal Code
S2000QGB
Country
Argentina
Facility Name
Revalidatie en MS Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Hospital das Clinicas - UFG
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Instituto Méderi de Pesquisa e Saúde
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Facility Name
IMV Pesquisa Neurológica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Clinica Neurologica; Neurocirurgica de Joinville
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
Hospital das Clinicas - UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-887
Country
Brazil
Facility Name
Praxis Pesquisa Médica
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09090-790
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHATNP Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Chum Campus Notre Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
MUCH - Montreal Neurological Institute & Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Hotel-Dieu de Levis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet Glostrup; Neurologisk Klinik
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Brest Hopital La Cavale Blanche; Neurologie
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Cote De Nacre; Unite Neurologie Generale
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Hopital Gabriel Montpied; Service de Neurologie
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH St Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Central - CHU de Nancy; Service de Neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Neurologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
401 Military Hospital of Athens; Neurology Department
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Hospital Eginition; First Department of Neurology
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
University General Hospital of Larisa; Neurology Clinic
City
Larisa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Kistarcsai Flor Ferenc Korhaz; Neurology and Stroke Ambulance
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
City
Gallarate
State/Province
Lombardia
ZIP/Postal Code
21013
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
AOU Città della Salute e della Scienza; Neurologia 1
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
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
Clinstile S.A de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Neurociencias Prisma, A.C
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78216
Country
Mexico
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
La Victoria, Lima
ZIP/Postal Code
Lima 13
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
City
Lima
ZIP/Postal Code
15003
Country
Peru
Facility Name
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
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
MA-LEK Clinical Sp. Z o.o.
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
EMC Instytut Medyczny SA
City
Pozna?
ZIP/Postal Code
60-309
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny Nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Nzoz Palomed
City
Rzeszów
ZIP/Postal Code
35-232
Country
Poland
Facility Name
Osrodek Badan Klinicznych Euromedis
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
National Center of Social Significant Disease
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Research Center of Neurology of RAMS
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Federal center of brain research and neurotechnologies
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
City Clinical Hospital #24; Multipal Sclerosis department
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
N.P. Bechtereva Institute of the Human Brain
City
Sankt-petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Hospital #40 of Kurortniy Administrative District
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Vertebronevrologiya LLC
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420047
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
State/Province
Uljanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Center of Cardiology and Neurology
City
Kirov
ZIP/Postal Code
610007
Country
Russian Federation
Facility Name
Regional clinical hospital named after prof. S.V. Ochapovsky
City
Krasnodar
ZIP/Postal Code
350086
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
Perm SMA n.a. academ. E.A. Vagner
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
EL Palmar (EL Palmar)
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Haseki Training and Research Hospital; Department of Neurology
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Sancaktepe Training and Research Hospital; Neurology
City
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Facility Name
Selcuk University Medical Faculty; Norology department
City
Istanbul
ZIP/Postal Code
42131
Country
Turkey
Facility Name
Erciyes Universitesi; Pediatric Neurology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Ege Üniversitesi Tip Fakültesi
City
Lzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu
City
Merkez
ZIP/Postal Code
58060
Country
Turkey
Facility Name
Mersin University Medical Faculty; Neurology
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
City
Çankaya
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Medical Center Dopomoga Plus
City
Kyiv
State/Province
Chernihiv Governorate
ZIP/Postal Code
02123
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
City
Zaporizhzhia
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
5th Cherkasy City Center of Primary Health Care
City
Cherkasy
State/Province
KIEV Governorate
ZIP/Postal Code
18029
Country
Ukraine
Facility Name
SI USSRI of Medical and Social Problems of Disabilities of MOHU
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Medical Center of Private Execution First Private Clinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Lvivska oblasna tsentralna likarnia
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Sumy Regional Clinical Hospital
City
Sumy
State/Province
Polissya Okruha
ZIP/Postal Code
40031
Country
Ukraine
Facility Name
Regional Clinical Hospital; Neurology Department
City
Ivano-Frankivsk
ZIP/Postal Code
76008
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
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
City
London
ZIP/Postal Code
WC1 3BG
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom

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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).

Learn more about this trial

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

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