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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance)

Primary Purpose

Relapsing Multiple Sclerosis

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

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
  • A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
  • Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
  • Ability to perform the 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:

  • Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.
  • Female participants who are pregnant or breastfeeding, or intending to become pregnant.
  • Male participants who intend to father a child during the study.
  • A diagnosis of PPMS or non-active SPMS.
  • 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).
  • 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.
  • Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • Hypoproteinemia.
  • Participants with several renal or hepatic disease impairment or Gilbert's Syndrome.
  • Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia.
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of HIV infection.
  • Inability to complete an MRI scan.
  • Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed).
  • Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
  • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

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.
  • Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label 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

  • University of Alabama BirminghamRecruiting
  • Alabama Neurology AssociatesRecruiting
  • Center for Neurology and Spine - Phoenix - Hunt - PPDSRecruiting
  • Profound Research, LLCRecruiting
  • University of California IrvineRecruiting
  • SC3 Research Group, IncRecruiting
  • University of Colorado DenverRecruiting
  • Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
  • Mountain View Clinical ResearchRecruiting
  • Advanced Neurology of Colorado, LLCRecruiting
  • Neurology Associates, PA; Research DepartmentRecruiting
  • Elite Clinical Research
  • Axiom Clinical Research of Florida
  • NorthShore University HealthSystemRecruiting
  • Fort Wayne Neurological Center
  • The NeuroMedical CenterRecruiting
  • Ochsner LSU HealthRecruiting
  • Johns Hopkins University School Of Medicine; Outpatient CenterRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • Henry Ford Health SystemRecruiting
  • Washington University School of MedicineRecruiting
  • Rutgers New Jersey Medical School
  • Holy Name Hospital; Institute For Clinical ResearchRecruiting
  • University of New Mexico; MS Specialty ClinicRecruiting
  • St. Lawrence Health System
  • Miami Valley Hospital South; Dayton Physician's OfficeRecruiting
  • OhioHealthRecruiting
  • The Boster Center for MS
  • MDH Research LLC
  • Oklahoma Medical Research Foundation; MS Center of ExcellenceRecruiting
  • St. Luke's University Health networkRecruiting
  • Premier NeurologyRecruiting
  • Neurology Clinic PC
  • New Orleans Center for Clinical ResearchRecruiting
  • North Texas Institute of Neurology and Headache NextStage Clinical Research ClinicRecruiting
  • Texas Institute for Neurological DisordersRecruiting
  • Blacksburg Neurology, PC
  • Multiple Sclerosis Center of Greater WashingtonRecruiting
  • Evergreen MS CenterRecruiting
  • MultiCare Health System Institute for Research and Innovation
  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological DisordersRecruiting
  • Fundacion FaicepRecruiting
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • NeuroSite
  • Instituto de Investigaciones Metabolicas (Idim)Recruiting
  • Diagnostico Medico OroñoRecruiting
  • Cer San JuanRecruiting
  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGYRecruiting
  • Peking University First Hospital
  • Beijing Tiantan Hospital,Capital Medical University
  • the First Hospital of Jilin University
  • Xiangya Hospital Central South UniversityRecruiting
  • West China Hospital, Sichuan University
  • The First Affiliated Hospital, Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Sun Yat-sen University
  • The second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The affiliated Hospital of Guiyang Medical CollegeRecruiting
  • Affiliated Hospital of Inner Mongolia Medical University
  • The First People?s Hospital of Yunnan ProvinceRecruiting
  • Lanzhou University Second HospitalRecruiting
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Soochow University; Neurology departmentRecruiting
  • 1st Affiliated Hospital of Shanxi Medical UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Tangdu Hospital, The Fourth Military Medical University; Neurology Department
  • NeuroINCRecruiting
  • Hospital Padre BilliniRecruiting
  • Helsinki University Central Hospital; Department of NeurologyRecruiting
  • Terveystalo Oulu
  • New Hospitals; Neurology and NeurorehabilitationRecruiting
  • Pineo Medical Ecosystem; Neurological DepartmentRecruiting
  • Archangel St. Michael Multiprofile Clinical HospitalRecruiting
  • MediClab GeorgiaRecruiting
  • Khechinashvili University Hospital; Neurological DepartmentRecruiting
  • Jüdisches Krankenhaus Berlin; Abteilung fur NeurologieRecruiting
  • Studienzentrum für Neurologie und PsychiatrieRecruiting
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsklinikum Gießen und Marburg GmbH; NeurologieRecruiting
  • Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. NeurologieRecruiting
  • Universitätsklinikum Münster; Klinik und Poliklinik für NeurologieRecruiting
  • Nordwest-Krankenhaus Sanderbusch gGMBH; Neurologische KlinikRecruiting
  • Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und PsychiatrieRecruiting
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Universitätsklinikum Ulm; Klinik für NeurologieRecruiting
  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang SchwarzRecruiting
  • Pamela Youde Nethersole Eastern Hospital; Department of Medicine
  • Queen Mary Hospital; Department of Medicine, Division of Neurology
  • Prince of Wales Hospital; Division of Neurology, Department of Medicine and TherapeuticsRecruiting
  • Clinexpert Kft.
  • S-Medicon Egeszsegugyi Szolgaltato Kft.Recruiting
  • Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke OsztalyRecruiting
  • Pest Megyei Flor Ferenc Korhaz
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai KlinikaRecruiting
  • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi MultiplaRecruiting
  • AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica NeurologicaRecruiting
  • AOU Policlinico - Università L. Vanvitelli; D.A.I. di Medicina Interna e SpecialisticaRecruiting
  • A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)Recruiting
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi MultiplaRecruiting
  • Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute MentaleRecruiting
  • Azienda Ospedaliera Sant'Andrea; UOC NeurologiaRecruiting
  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi MultiplaRecruiting
  • Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero NeurologicoRecruiting
  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi MultiplaRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di AnconaRecruiting
  • Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi MultiplaRecruiting
  • AO.U. Policlinico Riuniti Foggia; Neurologia Univ.-Centro intradip. malattie demielinizzantiRecruiting
  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi MultiplaRecruiting
  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2Recruiting
  • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia SperimentaleRecruiting
  • Azienda Ospedaliera di Padova; Clinica NeurologicaRecruiting
  • Aga Khan University HospitalRecruiting
  • Clinical Research Institute SaltilloRecruiting
  • Health Pharma Professional Research
  • Grupo Medico de Investigacion Clinica MultidisciplinariaRecruiting
  • Neurociencias Estudios Clinicos S.C.Recruiting
  • Hospital General de Mexico
  • Centre Hospitalo-universitaire Mohammed VI d?Oujda; Neurology
  • Zuyderland Medisch Centrum - Sittard GeleenRecruiting
  • PHO General City Hospital 8th September Center for dialysisRecruiting
  • University Clinic for Neurology - SkopjeRecruiting
  • Clinical Hospital Stip
  • Hospital IV Alberto Sabogal Sologuren; Unidad de InvestigacionRecruiting
  • HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN; Unidad de Investigacion en Neurologia
  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de NeurologiaRecruiting
  • Clinica Internacional Sede LimaRecruiting
  • Hospital Maria Auxiliadora
  • ASOCIACION CIVIL PORLASALUD; Unidad de Investigación
  • Clinica Centenario Peruano Japonesa; NeurologyRecruiting
  • ProNeuro Centrum MedyczneRecruiting
  • Neurocentrum Bydgoszcz sp. z o.o
  • Neurocentrum Bydgoszcz sp. z o.oRecruiting
  • Care ClinicRecruiting
  • MT Medic KrosnoRecruiting
  • Centrum Neurologii Krzysztof SelmajRecruiting
  • Rodzinne Centrum Medyczne Lubimed.plRecruiting
  • Wojewodzki Szpital Specjalistyczny im. Sw. Jadwigi Slaskiej; Oddzia? NeurologiiRecruiting
  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka KomandytowaRecruiting
  • MedPoloniaRecruiting
  • Instytut Psychiatrii i Neurologii II Klinika NeurologicznaRecruiting
  • IBISMED Wielospecjalistyczne Centrum MedyczneRecruiting
  • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • HUC; Servico de NeurologiaRecruiting
  • Hospital Santo Antonio dos Capuchos; Servico de NeurologiaRecruiting
  • Hospital da Luz; NeurologiaRecruiting
  • Hospital de Santa Maria; Servico de Neurologia
  • Hospital Beatriz Angelo; Servico de Neurologia
  • Hospital Geral de Santo Antonio; Servico de NeurologiaRecruiting
  • Hospital de Sao Joao; Servico de NeurologiaRecruiting
  • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião; Servilo de Neurologia
  • Regional State Budgetary Institution of Healthcare "Regional Clinical Hospital"
  • Republican clinical hospital named after G.G. KuvatovRecruiting
  • N.P. Bechtereva Institute of the Human BrainRecruiting
  • Leningrad Regional Clinical HospitalRecruiting
  • Pavlov State Medical Uni ; NeurologyRecruiting
  • SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
  • Ulyanovsk Regional Clinical HospitalRecruiting
  • Center of Cardiology and NeurologyRecruiting
  • FSBIH Siberian Regional Medical Centre of FMBA of Russia
  • Hospital Universitari de Bellvitge; Servicio de NeurologiaRecruiting
  • Hospital Quiron de Madrid; Servicio de NeurologiaRecruiting
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Hospital Alvaro Cunqueiro; Servicio de NeurologiaRecruiting
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-InmunologiaRecruiting
  • Hospital Universitario de la Princesa; Servicio de NeurologiaRecruiting
  • Hospital General Universitario Gregorio Marañon; Servicio de NeurologiaRecruiting
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Fundacion Jimenez Diaz; Servicio de NeurologíaRecruiting
  • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de NeurologiaRecruiting
  • Hospital Universitario Virgen Macarena; Servicio de NeurologiaRecruiting
  • Inselspital Bern Medizin Neurologie; Neurologische PoliklinikRecruiting
  • Ospedale Regionale di Lugano - Civico; NeurologiaRecruiting
  • China Medical University Hospital; Neurology
  • National Taiwan University Hospital; Neurology
  • Chang Gung Memorial Foundation - Linkou - Neurology
  • Medical Center Dopomoga Plus
  • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
  • Zaporizhia City Multispecialty Clinical Hospital #9
  • Separated structural unit ?University clinic? of Dnipro State Medical University
  • SI USSRI of Medical and Social Problems of Disabilities of MOHURecruiting
  • Medical Center of Private Execution First Private Clinic
  • Salutem Medical Center
  • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Ams of Ukraine; Inst. of Neurology, Psychiatry & NarcologyRecruiting
  • Lviv Regional Clinical Hospital; Department of Neurology
  • Odesa Regional Clinical Hospital; Neurosurgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fenebrutinib

Teriflunomide

Arm Description

Participants will receive oral fenebrutinib with teriflunomide-matching placebo.

Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR)

Secondary Outcome Measures

Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
Time to Onset of Composite 24-week Confirmed Disability Progression (cCDP24)
Time to Onset of 12-week Confirmed Disability Progression (CDP12)
Time to Onset of 24-week Confirmed Disability Progression (CDP24)
Total Number of T1 Gadolinium Enhancing (Gd+) Lesions, New and/or Enlarging T2-weighted Lesions as Detected by Magnetic Resonance Imaging (MRI)
Percentage Change in Total Brain Volume from Week 24 as Assessed by MRI
Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis, 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, is 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.
Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (NfL)
Percentage of Participants with Adverse Events (AEs)
Plasma Concentrations of Fenebrutinib at Specified Timepoints

Full Information

First Posted
October 8, 2020
Last Updated
October 11, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04586010
Brief Title
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Acronym
FENhance
Official Title
A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
October 2, 2025 (Anticipated)
Study Completion Date
November 27, 2025 (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 and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. 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
Relapsing Multiple Sclerosis

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
736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fenebrutinib
Arm Type
Experimental
Arm Description
Participants will receive oral fenebrutinib with teriflunomide-matching placebo.
Arm Title
Teriflunomide
Arm Type
Active Comparator
Arm Description
Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.
Intervention Type
Drug
Intervention Name(s)
Fenebrutinib
Intervention Description
Participants will receive fenebrutinib.
Intervention Type
Drug
Intervention Name(s)
Teriflunomide
Intervention Description
Participants will receive teriflunomide.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR)
Time Frame
Minimum of 96 weeks
Secondary Outcome Measure Information:
Title
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
Time Frame
Minimum of 96 weeks
Title
Time to Onset of Composite 24-week Confirmed Disability Progression (cCDP24)
Time Frame
Minimum of 96 weeks
Title
Time to Onset of 12-week Confirmed Disability Progression (CDP12)
Time Frame
Minimum of 96 weeks
Title
Time to Onset of 24-week Confirmed Disability Progression (CDP24)
Time Frame
Minimum of 96 weeks
Title
Total Number of T1 Gadolinium Enhancing (Gd+) Lesions, New and/or Enlarging T2-weighted Lesions as Detected by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline, Weeks 12, 24, 48 and 96
Title
Percentage Change in Total Brain Volume from Week 24 as Assessed by MRI
Time Frame
From Week 24 to Week 96
Title
Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis, 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 and 96
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, is 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 96 weeks
Title
Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (NfL)
Time Frame
Up to 48 weeks
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to 4.5 years
Title
Plasma Concentrations of Fenebrutinib at Specified Timepoints
Time Frame
Up to 4.5 years

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: Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening. A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria. Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds. Ability to perform the 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: Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0. Female participants who are pregnant or breastfeeding, or intending to become pregnant. Male participants who intend to father a child during the study. A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS). Any known or suspected active infection 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). History of cancer including hematologic malignancy and solid tumors within 10 years of screening. Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Hypoproteinemia. Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia. Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. History of alcohol or other drug abuse within 12 months prior to screening. History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection. Inability to complete an MRI scan. Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed). Receipt of a live-attenuated vaccine within 6 weeks prior to randomization. Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period. 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. Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GN41851 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Alabama Neurology Associates
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Neurology and Spine - Phoenix - Hunt - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Profound Research, LLC
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Name
SC3 Research Group, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mountain View Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Neurology of Colorado, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Associates, PA; Research Department
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Elite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Withdrawn
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Withdrawn
Facility Name
NorthShore University HealthSystem
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The NeuroMedical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner LSU Health
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University School Of Medicine; Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Withdrawn
Facility Name
Holy Name Hospital; Institute For Clinical Research
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico; MS Specialty Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Lawrence Health System
City
Canton
State/Province
New York
ZIP/Postal Code
13617
Country
United States
Individual Site Status
Withdrawn
Facility Name
Miami Valley Hospital South; Dayton Physician's Office
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
The Boster Center for MS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MDH Research LLC
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oklahoma Medical Research Foundation; MS Center of Excellence
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Luke's University Health network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Neurology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Withdrawn
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Institute for Neurological Disorders
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
Blacksburg Neurology, PC
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Individual Site Status
Withdrawn
Facility Name
Multiple Sclerosis Center of Greater Washington
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Individual Site Status
Recruiting
Facility Name
Evergreen MS Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Withdrawn
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
Individual Site Status
Recruiting
Facility Name
Fundacion Faicep
City
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
NeuroSite
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1405CBA
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Investigaciones Metabolicas (Idim)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Diagnostico Medico Oroño
City
Rosario
ZIP/Postal Code
S2000CTC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cer San Juan
City
San Juan
ZIP/Postal Code
J5400CEP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing City
ZIP/Postal Code
100050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou City
ZIP/Postal Code
510080
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou City
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
The affiliated Hospital of Guiyang Medical College
City
Guiyang
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot City
ZIP/Postal Code
010000
Country
China
Individual Site Status
Withdrawn
Facility Name
The First People?s Hospital of Yunnan Province
City
Kunming City
ZIP/Postal Code
650021
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University; Neurology department
City
Suzhou City
ZIP/Postal Code
215031
Country
China
Individual Site Status
Recruiting
Facility Name
1st Affiliated Hospital of Shanxi Medical University
City
Taiyuan City
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Tangdu Hospital, The Fourth Military Medical University; Neurology Department
City
Xi'an City
ZIP/Postal Code
710038
Country
China
Individual Site Status
Active, not recruiting
Facility Name
NeuroINC
City
Santiago de los Caballeros
ZIP/Postal Code
51000
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Name
Hospital Padre Billini
City
Santo Domingo
ZIP/Postal Code
10210
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Name
Helsinki University Central Hospital; Department of Neurology
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
Terveystalo Oulu
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Individual Site Status
Withdrawn
Facility Name
New Hospitals; Neurology and Neurorehabilitation
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Pineo Medical Ecosystem; Neurological Department
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Archangel St. Michael Multiprofile Clinical Hospital
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
MediClab Georgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Khechinashvili University Hospital; Neurological Department
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum für Neurologie und Psychiatrie
City
Böblingen
ZIP/Postal Code
71034
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Nordwest-Krankenhaus Sanderbusch gGMBH; Neurologische Klinik
City
Sande
ZIP/Postal Code
26452
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Name
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital; Department of Medicine, Division of Neurology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Prince of Wales Hospital; Division of Neurology, Department of Medicine and Therapeutics
City
Shatin, New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
S-Medicon Egeszsegugyi Szolgaltato Kft.
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Policlinico - Università L. Vanvitelli; D.A.I. di Medicina Interna e Specialistica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
City
Gallarate
State/Province
Lombardia
ZIP/Postal Code
21013
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
City
Torrette - Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla
City
Mondovì (CN)
State/Province
Piemonte
ZIP/Postal Code
12084
Country
Italy
Individual Site Status
Recruiting
Facility Name
AO.U. Policlinico Riuniti Foggia; Neurologia Univ.-Centro intradip. malattie demielinizzanti
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Padova; Clinica Neurologica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aga Khan University Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute Saltillo
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Grupo Medico de Investigacion Clinica Multidisciplinaria
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital General de Mexico
City
Mexico
State/Province
Tlaxcala
ZIP/Postal Code
06726
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalo-universitaire Mohammed VI d?Oujda; Neurology
City
Oujda
Country
Morocco
Individual Site Status
Withdrawn
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
PHO General City Hospital 8th September Center for dialysis
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Recruiting
Facility Name
University Clinic for Neurology - Skopje
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Stip
City
Stip
ZIP/Postal Code
2000
Country
North Macedonia
Individual Site Status
Active, not recruiting
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Individual Site Status
Recruiting
Facility Name
HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN; Unidad de Investigacion en Neurologia
City
La Victoria, Lima
ZIP/Postal Code
Lima 13
Country
Peru
Individual Site Status
Active, not recruiting
Facility Name
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
City
Lima
ZIP/Postal Code
15003
Country
Peru
Individual Site Status
Recruiting
Facility Name
Clinica Internacional Sede Lima
City
LIma
ZIP/Postal Code
Lima 01
Country
Peru
Individual Site Status
Recruiting
Facility Name
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Individual Site Status
Active, not recruiting
Facility Name
ASOCIACION CIVIL PORLASALUD; Unidad de Investigación
City
Miraflores
ZIP/Postal Code
15046
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Clinica Centenario Peruano Japonesa; Neurology
City
Pueblo Libre
ZIP/Postal Code
Lima 21
Country
Peru
Individual Site Status
Recruiting
Facility Name
ProNeuro Centrum Medyczne
City
?ory
ZIP/Postal Code
44-240
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Care Clinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Individual Site Status
Recruiting
Facility Name
MT Medic Krosno
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Individual Site Status
Recruiting
Facility Name
Rodzinne Centrum Medyczne Lubimed.pl
City
Lublin
ZIP/Postal Code
20-492
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Sw. Jadwigi Slaskiej; Oddzia? Neurologii
City
Opole
ZIP/Postal Code
45-221
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
City
Pozna?
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
MedPolonia
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Name
IBISMED Wielospecjalistyczne Centrum Medyczne
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital da Luz; Neurologia
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Santa Maria; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Hospital Beatriz Angelo; Servico de Neurologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Sao Joao; Servico de Neurologia
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião; Servilo de Neurologia
City
Santa Maria Da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Regional State Budgetary Institution of Healthcare "Regional Clinical Hospital"
City
Barnaul
State/Province
Altaj
ZIP/Postal Code
656024
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Republican clinical hospital named after G.G. Kuvatov
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
N.P. Bechtereva Institute of the Human Brain
City
Sankt-petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Pavlov State Medical Uni ; Neurology
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
State/Province
Uljanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Center of Cardiology and Neurology
City
Kirov
ZIP/Postal Code
610007
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
FSBIH Siberian Regional Medical Centre of FMBA of Russia
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
EL Palmar (EL Palmar)
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Alvaro Cunqueiro; Servicio de Neurologia
City
Vigo
State/Province
Pontevedra
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de la Princesa; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Fundacion Jimenez Diaz; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Ospedale Regionale di Lugano - Civico; Neurologia
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital; Neurology
City
North Dist.
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
National Taiwan University Hospital; Neurology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Chang Gung Memorial Foundation - Linkou - Neurology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Medical Center Dopomoga Plus
City
Kyiv
State/Province
Chernihiv Governorate
ZIP/Postal Code
02123
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
City
Lviv
State/Province
Chernihiv Governorate
ZIP/Postal Code
79007
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
City
Zaporizhzhia
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Zaporizhia City Multispecialty Clinical Hospital #9
City
Zaporizhzhye
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69063
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Separated structural unit ?University clinic? of Dnipro State Medical University
City
Dnipro
State/Province
Kharkiv Governorate
ZIP/Postal Code
49038
Country
Ukraine
Individual Site Status
Active, not recruiting
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
Individual Site Status
Recruiting
Facility Name
Medical Center of Private Execution First Private Clinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Salutem Medical Center
City
Vinnytsia
State/Province
KIEV Governorate
ZIP/Postal Code
21050
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21009
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Lviv Regional Clinical Hospital; Department of Neurology
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Odesa Regional Clinical Hospital; Neurosurgery Department
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.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 Teriflunomide in Relapsing Multiple Sclerosis (RMS)

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