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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis (FENtrepid)

Primary Purpose

Multiple Sclerosis, Primary Progressive

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fenebrutinib
Ocrelizumab
Placebo matched to ocrelizumab
Placebo matched to fenebrutinib
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:

  • A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).
  • Disability progression in the 12 months prior to screening.
  • Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.
  • Pyramidal functional subscore >=2 at screening.
  • For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for Multiple Sclerosis (MS) (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.
  • Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
  • Ability to perform Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Exclusion Criteria:

  • Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
  • Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.
  • History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
  • Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
  • Male participants intending to father a child during the study or for 28 days after final dose of study drug.
  • Lack of peripheral venous access.
  • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.

OLE Inclusion Criteria:

  • Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Sites / Locations

  • Alabama Neurology Associates
  • Sutter East Bay Medical Foundation
  • Fullerton Neurology and Headache Center
  • Palo Alto Medical Foundation Research Center
  • University of Colorado Denver
  • Yale University School Of Medicine
  • Georgetown University Medical Center
  • Uni of Miami School of Medicine
  • Neurological Services of Orlando
  • University of South Florida
  • Josephson Wallack Munshower Neurology PC
  • University of Kansas Medical Center
  • Johns Hopkins University School Of Medicine; Outpatient Center
  • Dragonfly Research, LLC
  • Wayne State University
  • Minneapolis Clinic of Neurology
  • Washington University
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • Hackensack U Med Ctr
  • Barnabas Health Ambulatory Care Center
  • Jersey Shore University Medical Centre
  • Rutgers New Jersey Medical School
  • Holy Name Hospital; Institute For Clinical Research
  • Dent Neurological Institute
  • Columbia University Medical Center
  • University of Rochester
  • Stony Brook University Medical Center
  • SUNY Upstate Medical University
  • Atrium Health Neurosciences Institute ? Charlotte
  • Neurology Associates PA
  • Raleigh Neurology Associates
  • Miami Valley Hospital South; Dayton Physician's Office
  • UC Health, LLC.
  • OhioHealth Riverside Methodist Hospital; Pharmacy Services
  • Providence Brain and Spine Institute
  • Neurology Clinic PC
  • Hope Neurology
  • Vanderbilt University Medical Center
  • Uni of Texas Health Science Center At Houston
  • Texas Institute for Neurological Disorders
  • Evergreen MS Center
  • Swedish Medical Center
  • West Virginia University
  • Medical College of Wisconsin, Inc.
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • Instituto De Neurología Cognitiva - INECO
  • Instituto de Investigaciones Metabolicas (Idim)
  • Instituto Reumatológico Strusberg
  • Fundacion Rosarina de Neurorehabilitacion
  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
  • Brain and Mind Research Institute
  • Liverpool Hospital
  • John Hunter Hospital
  • Princess Alexandra Hospital
  • Box Hill Hospital; Department of Neurology
  • Austin Hospital; Department of Neurology
  • Royal Melbourne Hospital; Department of Neurology
  • Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
  • Medizinische Universität Wien; Univ.Klinik fuer Neurologie
  • Santa Casa de Misericordia; de Belo Horizonte
  • Instituto de Neurologia de Curitiba
  • Hospital Universitario Gaffree e Guinle
  • IMV Pesquisa Neurológica
  • Núcleo de Pesquisa do Rio Grande do Sul
  • Clinica Neurologica; Neurocirurgica de Joinville
  • Centro de Pesquisas Clinicas; CPCLIN
  • UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
  • University of Alberta Hospital
  • Fraser Health Authority - Fraser Health Multiple Sclerosis
  • University of British Columbia
  • Regional health authority A vitalite health network
  • London Health Sciences Centre Uni Campus
  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital; MS Clinic
  • Clinique NeuroOutaouais
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital
  • CeCim Biocinetic
  • Clinica Alemana
  • Organizacion Sanitas Internacional
  • Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
  • Instituto Neurologico de Colombia INDEC
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Rigshospitalet; Neurologisk Klinik Glostrup
  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B
  • Hopital Pierre Wertheimer; Neurologie D
  • CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
  • Hopital Guillaume Et Rene Laennec
  • Hôpital Pasteur; Service de Neurologie
  • Hopital Civil de Strasbourg; Service de Neurologie
  • Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
  • Studienzentrum für Neurologie und Psychiatrie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
  • Universitaetsklinikum Tuebingen; Abteilung Neurologie
  • Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
  • 401 Military Hospital of Athens; Neurology Department
  • Hospital Eginition; First Department of Neurology
  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
  • Clinexpert Kft.
  • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
  • Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
  • Pest Megyei Flor Ferenc Korhaz
  • Rambam Medical Center; Neurology Unit
  • The Chaim Sheba Medical Center; Multiple Sclerosis Center
  • Tel Aviv Sourasky Medical Center; Department of Neurology
  • AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
  • A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
  • Mexico Centre for Clinical Research
  • Grupo Médico Camino S.C.
  • Hospital Juarez de Mexico
  • Clinstile S.A de C.V.
  • Clinical Research Institute
  • University Clinic of Neurology; Movement Disorders
  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Clinica Internacional; Unidad De Investigacion
  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
  • Neurocentrum Bydgoszcz sp. z o.o
  • Care Clinic
  • Centrum Neurologii Krzysztof Selmaj
  • Med Polonia
  • Centrum Medyczne "MEDYK"
  • Nzoz Palomed
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Centrum Medyczne NeuroProtect
  • Wro Medica
  • SPSK nr 1; Klinika Neurologii
  • Hospital de Braga; Servico de Neurologia
  • Hospital Santo Antonio dos Capuchos; Servico de Neurologia
  • Hospital de Santa Maria; Servico de Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Hospital de Sao Joao; Servico de Neurologia
  • San Juan MS Center
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • Krasnoyarsk State Medical Academy
  • National Center of Social Significant Disease
  • Federal center of brain research and neurotechnologies
  • City Clinical Hospital #24; Multipal Sclerosis department
  • City Hospital #40 of Resort Administrative District
  • Sverdlovsk Regional Clinical Hospital 1
  • Vertebronevrologiya LLC
  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
  • Center of Cardiology and Neurology
  • State Novosibirsk Regional Clinical Hospital
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Hospital Alvaro Cunqueiro; Servicio de Neurologia
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Hospital Puerta del Mar; Sevicio de Neurologia
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Universitätsspital Basel; Neurologie
  • Inselspital Bern Medizin Neurologie
  • Hacettepe University Medical Faculty; Neurology
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Sancaktepe Training and Research Hospital; Neurology
  • Selcuk University Medical Faculty; Norology department
  • Katip Celebi University Ataturk Training and Research Hospital; Neurology
  • Kocaeli University Hospital; Department of Neurology
  • Mersin University Medical Faculty; Neurology
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • Van Yuzuncu Yil University Hospital; Neurology
  • Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
  • CNPE City Clinical Hospital #3 of Chernivtsi City Council
  • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
  • Medical Centre of PE First Private Clinic
  • Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1
  • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • MEDBUD
  • Lviv Regional Clinical Hospital
  • Salutem Medical Center
  • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Regional Clinical Hospital; Neurology Department
  • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
  • Volyn Regional Clinical Hospital
  • Odesa Regional Clinical Hospital; Neurosurgery Department
  • Queen Elizabeth University Hospital
  • Charing Cross Hospital
  • Nottingham University Hospitals NHS Trust
  • Derriford Hospital
  • Royal Hallamshire Hospita
  • Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fenebrutinib

Ocrelizumab

Arm Description

Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.

Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.

Outcomes

Primary Outcome Measures

Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)

Secondary Outcome Measures

Time to Onset of Composite 24-week CDP (cCDP24)
Time to Onset of 12-week CDP (CDP12)
Time to Onset of 24-week CDP (CDP24)
Percentage Change in Total Brain Volume Assessed by Magnetic Resonance Imaging (MRI)
Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] Physical Scale
The MSIS-29, Version 2 is a 29-item patient-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). The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.
Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) Score
The SDMT is used for detecting the presence of cognitive impairment and changes in cognitive functioning over time and in response to treatment. The SDMT is brief, easy to administer test, and involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected only orally, and administration time is approximately 5 minutes. The number of correct responses in 90 seconds will be considered the SDMT score. A decrease by 4 points on the SDMT score from baseline represents a clinically meaningful change in cognitive processing. The SDMT score ranges from 0 to 110. The higher the results, the better processing speed/working memory.
Percentage of Participants with Adverse Events (AEs)
Plasma Concentrations of Fenebrutinib at Specified Timepoints
Percent Change from Screening in Serum Neurofilament Light Chain (NfL) Levels

Full Information

First Posted
September 4, 2020
Last Updated
September 11, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04544449
Brief Title
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
Acronym
FENtrepid
Official Title
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
January 16, 2026 (Anticipated)
Study Completion Date
December 18, 2026 (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

5. Study Description

Brief Summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

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
Masking Description
Sponsor will also be blinded.
Allocation
Randomized
Enrollment
985 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenebrutinib
Arm Type
Experimental
Arm Description
Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
Arm Title
Ocrelizumab
Arm Type
Active Comparator
Arm Description
Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.
Intervention Type
Drug
Intervention Name(s)
Fenebrutinib
Intervention Description
Participants will receive fenebrutinib.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Participants will receive ocrelizumab.
Intervention Type
Drug
Intervention Name(s)
Placebo matched to ocrelizumab
Intervention Description
Participants will receive ocrelizumab-matching placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo matched to fenebrutinib
Intervention Description
Participants will receive fenebrutinib-matching placebo
Primary Outcome Measure Information:
Title
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
Time Frame
Minimum of 120 weeks
Secondary Outcome Measure Information:
Title
Time to Onset of Composite 24-week CDP (cCDP24)
Time Frame
Minimum of 120 weeks
Title
Time to Onset of 12-week CDP (CDP12)
Time Frame
Minimum of 120 weeks
Title
Time to Onset of 24-week CDP (CDP24)
Time Frame
Minimum of 120 weeks
Title
Percentage Change in Total Brain Volume Assessed by Magnetic Resonance Imaging (MRI)
Time Frame
From Week 24 to Week 120
Title
Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] Physical Scale
Description
The MSIS-29, Version 2 is a 29-item patient-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). The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120
Title
Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) Score
Description
The SDMT is used for detecting the presence of cognitive impairment and changes in cognitive functioning over time and in response to treatment. The SDMT is brief, easy to administer test, and involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected only orally, and administration time is approximately 5 minutes. The number of correct responses in 90 seconds will be considered the SDMT score. A decrease by 4 points on the SDMT score from baseline represents a clinically meaningful change in cognitive processing. The SDMT score ranges from 0 to 110. The higher the results, the better processing speed/working memory.
Time Frame
Minimum of 120 weeks
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to 4.7 years
Title
Plasma Concentrations of Fenebrutinib at Specified Timepoints
Time Frame
Up to 4.7 years
Title
Percent Change from Screening in Serum Neurofilament Light Chain (NfL) Levels
Time Frame
Up to Week 120

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: For sites in Germany and Italy only, enrollment is restricted to participants aged 46-65 years A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018). Disability progression in the 12 months prior to screening. Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening. Pyramidal functional subscore >=2 at screening. For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for MS (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment. Neurologically stable for at least 30 days prior to randomization and baseline assessments. Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds. Ability to perform Timed 25-Foot Walk Test (T25FWT) in <150 seconds. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. Exclusion Criteria: For participants enrolled in Germany and in Italy only: Presence of gadolinium-enhancing lesions on T1-weighted MRI (T1Gd +) lesion on the screening MRI Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a positive screening test for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML). Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab. History of cancer including hematologic malignancy and solid tumors within 10 years of screening. Exceptions: Basal/squamous cell carcinoma of skin cured by excision. In situ carcinoma of the cervix successfully treated by curative therapy >1 year prior to screening. Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. Presence of cirrhosis (Child-Pugh Class A, B, or C) Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study. History of alcohol or other drug abuse within 12 months prior to screening. Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug. Male participants intending to father a child during the study or for 28 days after final dose of study drug. Lack of peripheral venous access. Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period. Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization. Immunocompromised state, history of primary or secondary (non-drug related) immunodeficiency, or history of transplantation or antirejection therapy Known bleeding diathesis, anemia, or history of hospitalization or transfusion for gastrointestinal (GI) bleed Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide OLE Inclusion Criteria: Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
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
Sutter East Bay Medical Foundation
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Fullerton Neurology and Headache Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Palo Alto Medical Foundation Research Center
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Uni of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Josephson Wallack Munshower Neurology PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University School Of Medicine; Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dragonfly Research, LLC
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Hackensack U Med Ctr
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Barnabas Health Ambulatory Care Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
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
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Holy Name Hospital; Institute For Clinical Research
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Atrium Health Neurosciences Institute ? Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Neurology Associates PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
Miami Valley Hospital South; Dayton Physician's Office
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
UC Health, LLC.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
OhioHealth Riverside Methodist Hospital; Pharmacy Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Providence Brain and Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Hope Neurology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Uni of Texas Health Science Center At Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Institute for Neurological Disorders
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Evergreen MS Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-1360
Country
United States
Facility Name
West Virginia University
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Facility Name
Instituto De Neurología Cognitiva - INECO
City
Caba
ZIP/Postal Code
C1126AAB
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas (Idim)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Instituto Reumatológico Strusberg
City
Cordoba
ZIP/Postal Code
X5000EDC
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
ZIP/Postal Code
S2000BZL
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Brain and Mind Research Institute
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Box Hill Hospital; Department of Neurology
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Hospital; Department of Neurology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Neurology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Hospital Universitario Gaffree e Guinle
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20270-004
Country
Brazil
Facility Name
IMV Pesquisa Neurológica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Facility Name
Núcleo de Pesquisa do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Clinica Neurologica; Neurocirurgica de Joinville
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas; CPCLIN
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Fraser Health Authority - Fraser Health Multiple Sclerosis
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
Regional health authority A vitalite health network
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
London Health Sciences Centre Uni Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital; MS Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B-1W8
Country
Canada
Facility Name
Clinique NeuroOutaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
CeCim Biocinetic
City
Santiago
ZIP/Postal Code
8331143
Country
Chile
Facility Name
Clinica Alemana
City
Vitacura
ZIP/Postal Code
0
Country
Chile
Facility Name
Organizacion Sanitas Internacional
City
Bogota, D.C.
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
City
Cali
Country
Colombia
Facility Name
Instituto Neurologico de Colombia INDEC
City
Medellin
Country
Colombia
Facility Name
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet; Neurologisk Klinik Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Pierre Wertheimer; Neurologie D
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Guillaume Et Rene Laennec
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Pasteur; Service de Neurologie
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hopital Civil de Strasbourg; Service de Neurologie
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Studienzentrum für Neurologie und Psychiatrie
City
Böblingen
ZIP/Postal Code
71034
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen; Abteilung Neurologie
City
Tuebingen
ZIP/Postal Code
72076
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
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
S-Medicon Egeszsegugyi Szolgaltato Kft.
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Facility Name
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Rambam Medical Center; Neurology Unit
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Chaim Sheba Medical Center; Multiple Sclerosis Center
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Department of Neurology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
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
A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
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
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
Country
Italy
Facility Name
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Mexico Centre for Clinical Research
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Grupo Médico Camino S.C.
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03600
Country
Mexico
Facility Name
Hospital Juarez de Mexico
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
07760
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
Clinical Research Institute
City
Tlalnepantla de Baz
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
54055
Country
Mexico
Facility Name
University Clinic of Neurology; Movement Disorders
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Clinica Internacional; Unidad De Investigacion
City
Lima
ZIP/Postal Code
15001
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
Care Clinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Med Polonia
City
Pozna?
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Centrum Medyczne "MEDYK"
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Nzoz Palomed
City
Rzeszów
ZIP/Postal Code
35-232
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice ?l?skie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Wro Medica
City
Wroc?aw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
SPSK nr 1; Klinika Neurologii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Hospital de Braga; Servico de Neurologia
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
Hospital de Santa Maria; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital de Sao Joao; Servico de Neurologia
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
San Juan MS Center
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
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
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
City Hospital #40 of Resort Administrative District
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital 1
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
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
City
Tyumen
State/Province
Tjumen
ZIP/Postal Code
625048
Country
Russian Federation
Facility Name
Center of Cardiology and Neurology
City
Kirov
ZIP/Postal Code
610007
Country
Russian Federation
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
City
Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
City
Lleida
State/Province
Lerida
ZIP/Postal Code
25198
Country
Spain
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 Alvaro Cunqueiro; Servicio de Neurologia
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Puerta del Mar; Sevicio de Neurologia
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Universitätsspital Basel; Neurologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern Medizin Neurologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
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
Katip Celebi University Ataturk Training and Research Hospital; Neurology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Mersin University Medical Faculty; Neurology
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Van Yuzuncu Yil University Hospital; Neurology
City
Van
ZIP/Postal Code
65080
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
City
Çankaya
ZIP/Postal Code
06490
Country
Turkey
Facility Name
CNPE City Clinical Hospital #3 of Chernivtsi City Council
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
City
Lviv
State/Province
Chernihiv Governorate
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Medical Centre of PE First Private Clinic
City
Zhytomir
State/Province
Crimean Regional Governmenta
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1
City
Dnipro
State/Province
Katerynoslav Governorate
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
MEDBUD
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Salutem Medical Center
City
Vinnytsia
State/Province
KIEV Governorate
ZIP/Postal Code
21050
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
Regional Clinical Hospital; Neurology Department
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Odesa Regional Clinical Hospital; Neurosurgery Department
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Facility Name
Royal Hallamshire Hospita
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
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 and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

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