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Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance 2)

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 severe 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

  • North Central Neurology AssociatesRecruiting
  • XenoscienceRecruiting
  • Stanford University Medical Center; Stanford Neuroscience Health CenterRecruiting
  • Los Angeles Biomedical Research Institute at Harbor-UCLA
  • KI Health Partners, LLC; New England Institute for Clinical ResearchRecruiting
  • Georgetown University Medical CenterRecruiting
  • SFM Clinical Research, LLC
  • University of South FloridaRecruiting
  • Atlanta Neuroscience Institute
  • American Health Network Institute, LLCRecruiting
  • University of Kansas Medical CenterRecruiting
  • Neuro Institute of New England P.C.; ResearchRecruiting
  • Wayne State University; Department of NeurologyRecruiting
  • Memorial Healthcare Institute for Neurosciences and Multiple SclerosisRecruiting
  • Guilford Neurologic Research
  • NeuroScience Research Center
  • University of Cincinnati; Department of NeurologyRecruiting
  • Providence Neurological Specialties
  • Geisinger Medical Center
  • Allegheny Neurological Associates
  • Hope Neurology
  • Baylor College of Medicine
  • Central Texas Neurology Consultants
  • Integrated Neurology Services PLLCRecruiting
  • Medical College of Wisconsin, Inc.
  • Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & PsychiatrieRecruiting
  • Medizinische Universität Wien; Univ.Klinik fuer Neurologie
  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
  • Santa Casa de Misericordia; de Belo Horizonte
  • Instituto de Neurologia de Curitiba
  • Hospital Universitario Clementino Fraga Filho - UFRJ
  • IMV Pesquisa Neurológica
  • Núcleo de Pesquisa do Rio Grande do SulRecruiting
  • Hospital Sao Lucas - PUCRSRecruiting
  • Clinica Neurologica; Neurocirurgica de Joinville
  • Hospital das Clinicas - UNICAMP
  • Praxis Pesquisa MédicaRecruiting
  • CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting
  • Centro de Pesquisas Clinicas; CPCLIN
  • Jordy Sinapse Medicina LTDA MERecruiting
  • Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas
  • UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
  • MHATNP Sveti Naum EAD
  • University of Alberta Hospital
  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi HospitalRecruiting
  • Recherche Sepmus Inc.
  • MUCH - Montreal Neurological Institute & Hospital
  • CHU de QuébecRecruiting
  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
  • Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
  • Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken
  • Rigshospitalet; Neurologisk Klinik Glostrup
  • Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie BRecruiting
  • Hopital européen de Marseille; Neurologie
  • Hopital Gui de Chauliac; NeurologieRecruiting
  • Hôpital Pasteur; Service de Neurologie
  • Hôpital Charles Nicolle; Service de NeurologieRecruiting
  • CHU toulouse - Hôpital Purpan; Departement de NeurologieRecruiting
  • University General Hospital of Larisa; Neurology Clinic
  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.Recruiting
  • Hospital Eginition; First Department of NeurologyRecruiting
  • University General Hospital of Ioannina; Neurology ClinicRecruiting
  • NucareRecruiting
  • Sir Gangaram HospitalRecruiting
  • Max Super Speciality HospitalRecruiting
  • Zydus Hospital; Department of Neuro SciencesRecruiting
  • Seth G.S Medical College K.E.M HospitalRecruiting
  • Sahyadri Superspeciality HospitalRecruiting
  • Deenanath Mangeshkar Hospital & Research Centre
  • Christian Medical College and HospitalRecruiting
  • Fortis Escorts Hospital
  • SRM Institute of Medical SciencesRecruiting
  • Postgraduate Institute of Medical Education and ResearchRecruiting
  • Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze ClinicheRecruiting
  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
  • Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
  • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
  • NCL Institute Neuroscience
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie NeuromuscolariRecruiting
  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla
  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
  • Ospedale Binaghi; Centro Sclerosi Multipla
  • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
  • Keimyung University Dongsan Medical CenterRecruiting
  • National Cancer Center
  • Seoul National University Hospital
  • Samsung Medical CenterRecruiting
  • Mexico Centre for Clinical Research
  • Grupo Médico Camino S.C.Recruiting
  • Clinstile S.A de C.V.
  • Unidad de Investigación en Salud; PsiquiatriaRecruiting
  • Unidad de investigacion en salud (UIS); Neurociencias
  • NZOZ VitamedRecruiting
  • Neurocentrum Bydgoszcz sp. z o.oRecruiting
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • Gornoslaskie Centrum MedyczneRecruiting
  • RESMEDICA Spolka z o.o.Recruiting
  • Centrum Neurologii KlinicznejRecruiting
  • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.Recruiting
  • MT Medic Krosno
  • Centrum Neurologii Krzysztof SelmajRecruiting
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Wojewodzki Szpital Specjalistyczny
  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.Recruiting
  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
  • MedPoloniaRecruiting
  • Wojewódzki Szpital Specjalistyczny Nr 3Recruiting
  • Klinika Neurologii I Wydzialu Lekarskiego WUM w WarszawieRecruiting
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Przychodnia EuroMediCare
  • Wro MedicaRecruiting
  • IBISMED Wielospecjalistyczne Centrum MedyczneRecruiting
  • San Juan MS Center
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological AgencyRecruiting
  • Krasnoyarsk State Medical AcademyRecruiting
  • National Center of Social Significant Disease
  • Federal center of brain research and neurotechnologiesRecruiting
  • Regional Clinical Hospital N.A. Semashko; NeurologyRecruiting
  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
  • Regional clinical hospital named after prof. S.V. OchapovskyRecruiting
  • State Novosibirsk Regional Clinical Hospital
  • Nebbiolo Center for Clinical TrialsRecruiting
  • Hacettepe University Medical Faculty; NeurologyRecruiting
  • Gazi University Medical Faculty; Departmant of Norology
  • Bakirkoy State Mental Hospital
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim DaliRecruiting
  • Sancaktepe Training and Research Hospital; Neurology
  • Selcuk University Medical Faculty; Norology department
  • Katip Celebi University Ataturk Training and Research Hospital; NeurologyRecruiting
  • Kocaeli University Hospital; Department of Neurology
  • Ege Üniversitesi Tip Fakültesi
  • Mersin University Medical Faculty; NeurologyRecruiting
  • Ondokuz Mayis University School of Medicine; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • Van Yuzuncu Yil University Hospital; NeurologyRecruiting
  • Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
  • RE:Cognition Health
  • Salford Royal NHS Foundation Trust
  • Recognition Health

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 20, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04586023
Brief Title
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Acronym
FENhance 2
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 24, 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 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, 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: GN42272 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
North Central Neurology Associates
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Individual Site Status
Recruiting
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University Medical Center; Stanford Neuroscience Health Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
KI Health Partners, LLC; New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
SFM Clinical Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Neuroscience Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Individual Site Status
Withdrawn
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro Institute of New England P.C.; Research
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Individual Site Status
Recruiting
Facility Name
Wayne State University; Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Individual Site Status
Recruiting
Facility Name
Guilford Neurologic Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Withdrawn
Facility Name
NeuroScience Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Cincinnati; Department of Neurology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Neurological Specialties
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Withdrawn
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hope Neurology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Withdrawn
Facility Name
Integrated Neurology Services PLLC
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Completed
Facility Name
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Clementino Fraga Filho - UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
IMV Pesquisa Neurológica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Núcleo de Pesquisa do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica Neurologica; Neurocirurgica de Joinville
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-887
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Praxis Pesquisa Médica
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09090-790
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisas Clinicas; CPCLIN
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Jordy Sinapse Medicina LTDA ME
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04515-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Completed
Facility Name
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
MHATNP Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Individual Site Status
Completed
Facility Name
MUCH - Montreal Neurological Institute & Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CHU de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Rigshospitalet; Neurologisk Klinik Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital européen de Marseille; Neurologie
City
Marseille
ZIP/Postal Code
13003
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pasteur; Service de Neurologie
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Charles Nicolle; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
CHU toulouse - Hôpital Purpan; Departement de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
University General Hospital of Larisa; Neurology Clinic
City
Larisa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hospital Eginition; First Department of Neurology
City
Αθηνα
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Ioannina; Neurology Clinic
City
Ιωαννινα
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Nucare
City
Ciudad Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Sir Gangaram Hospital
City
NEW Delhi Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Max Super Speciality Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Zydus Hospital; Department of Neuro Sciences
City
Ahmadabad CITY
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Individual Site Status
Recruiting
Facility Name
Seth G.S Medical College K.E.M Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Name
Sahyadri Superspeciality Hospital
City
Pune City
State/Province
Maharashtra
ZIP/Postal Code
411006
Country
India
Individual Site Status
Recruiting
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Christian Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Individual Site Status
Recruiting
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Individual Site Status
Withdrawn
Facility Name
SRM Institute of Medical Sciences
City
Vadapalani
State/Province
Tamil NADU
ZIP/Postal Code
600026
Country
India
Individual Site Status
Recruiting
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Name
Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Completed
Facility Name
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
NCL Institute Neuroscience
City
Roma
State/Province
Lazio
ZIP/Postal Code
00178
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Active, not recruiting
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
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Binaghi; Centro Sclerosi Multipla
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Mexico Centre for Clinical Research
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Grupo Médico Camino S.C.
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03600
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinstile S.A de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Unidad de Investigación en Salud; Psiquiatria
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Unidad de investigacion en salud (UIS); Neurociencias
City
Ciudad de México
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Gornoslaskie Centrum Medyczne
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Recruiting
Facility Name
RESMEDICA Spolka z o.o.
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Neurologii Klinicznej
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
MT Medic Krosno
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
City
Oswiecim
ZIP/Postal Code
32-600
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
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
City
Pozna?
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
MedPolonia
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewódzki Szpital Specjalistyczny Nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Przychodnia EuroMediCare
City
Wroc?aw
ZIP/Postal Code
50-220
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Wro Medica
City
Wroc?aw
ZIP/Postal Code
51-685
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
San Juan MS Center
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Individual Site Status
Withdrawn
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
Individual Site Status
Recruiting
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
National Center of Social Significant Disease
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal center of brain research and neurotechnologies
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Hospital N.A. Semashko; Neurology
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
City
Tyumen
State/Province
Tjumen
ZIP/Postal Code
625048
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Regional clinical hospital named after prof. S.V. Ochapovsky
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Nebbiolo Center for Clinical Trials
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty; Departmant of Norology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Bakirkoy State Mental Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sancaktepe Training and Research Hospital; Neurology
City
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Selcuk University Medical Faculty; Norology department
City
Istanbul
ZIP/Postal Code
42131
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Katip Celebi University Ataturk Training and Research Hospital; Neurology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege Üniversitesi Tip Fakültesi
City
Lzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Mersin University Medical Faculty; Neurology
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Van Yuzuncu Yil University Hospital; Neurology
City
Van
ZIP/Postal Code
65080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu
City
Çankaya
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
RE:Cognition Health
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Recognition Health
City
Winchester
ZIP/Postal Code
SO21 1HU
Country
United Kingdom
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

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

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