FENtrepid: A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04544449
Collaborator
(none)
946
199
2
90.7
4.8
0.1
Study Details
Study Description
Brief Summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
946 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Sponsor will also be blinded.
Primary Purpose:
Treatment
Official Title:
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.
Actual Study Start Date
:
Oct 26, 2020
Anticipated Primary Completion Date
:
Oct 30, 2025
Anticipated Study Completion Date
:
May 17, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: fenebrutinib Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo. |
Drug: fenebrutinib
Participants will receive fenebrutinib.
Drug: placebo
Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.
|
| Active Comparator: ocrelizumab Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo. |
Drug: ocrelizumab
Participants will receive ocrelizumab.
Drug: placebo
Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.
|
Outcome Measures
Primary Outcome Measures
- Time to onset of composite 12-week confirmed disability progression (cCDP12) [Minimum of 120 weeks]
Secondary Outcome Measures
- Time to onset of composite 24-week CDP (cCDP24) [Minimum of 120 weeks]
- Time to onset of 12-week CDP (CDP12) [Minimum of 120 weeks]
- Time to onset of 24-week CDP (CDP24) [Minimum of 120 weeks]
- Percentage Change in Total Brain Volume assessed by MRI [From Week 24 to Week 120]
- Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) [Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120]
Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale.
- Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score [Minimum of 120 weeks]
- Percentage of Participants with Adverse Events (AEs) [Up to 4.5 years]
- Plasma Concentrations of fenebrutinib at specified timepoints [Up to 4.5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).
-
Disability progression in the 12 months prior to screening.
-
Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.
-
Pyramidal functional subscore >=2 at screening.
-
For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for Multiple Sclerosis (MS) (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.
-
Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
-
Ability to perform Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
-
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
-
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
-
Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
-
Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.
-
History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
-
Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
-
Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
-
History of alcohol or other drug abuse within 12 months prior to screening.
-
Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
-
Male participants intending to father a child during the study or for 28 days after final dose of study drug.
-
Lack of peripheral venous access.
-
Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
-
Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
OLE Inclusion Criteria:
-
Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
-
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
-
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sutter East Bay Medical Foundation | Berkeley | California | United States | 94705 |
| 2 | Fullerton Neurology and Headache Center | Fullerton | California | United States | 92835 |
| 3 | Palo Alto Medical Foundation Research Center | Sunnyvale | California | United States | 94086 |
| 4 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
| 5 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06519 |
| 6 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 7 | Neurology Associates PA | Maitland | Florida | United States | 32751 |
| 8 | Uni of Miami School of Medicine | Miami | Florida | United States | 33136 |
| 9 | Neurological Services of Orlando | Orlando | Florida | United States | 32806 |
| 10 | University of South Florida | Tampa | Florida | United States | 33613-4706 |
| 11 | Vero Beach Neurology and Research Institute | Vero Beach | Florida | United States | 32860 |
| 12 | Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | United States | 46256 |
| 13 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 14 | University of Maryland Medical Center; Department of Neurology | Baltimore | Maryland | United States | 21201 |
| 15 | Johns Hopkins University School Of Medicine; Outpatient Center | Baltimore | Maryland | United States | 21287 |
| 16 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 17 | Minneapolis Clinic of Neurology | Golden Valley | Minnesota | United States | 55422 |
| 18 | Washington University | Saint Louis | Missouri | United States | 63128 |
| 19 | Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | United States | 89106 |
| 20 | Hackensack U Med Ctr | Hackensack | New Jersey | United States | 07601 |
| 21 | Barnabas Health Ambulatory Care Center | Livingston | New Jersey | United States | 07039 |
| 22 | Jersey Shore University Medical Centre | Neptune | New Jersey | United States | 07753 |
| 23 | Rutgers New Jersey Medical School | Newark | New Jersey | United States | 07103 |
| 24 | Holy Name Hospital; Institute For Clinical Research | Teaneck | New Jersey | United States | 07666 |
| 25 | Dent Neurological Institute | Amherst | New York | United States | 14226 |
| 26 | NYU Winthrop-Huntington, NY | Huntington Station | New York | United States | 11746 |
| 27 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 28 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 29 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 30 | Atrium Health Neurosciences Institute - Charlotte | Charlotte | North Carolina | United States | 28204 |
| 31 | Raleigh Neurology Associates | Raleigh | North Carolina | United States | 27607-6520 |
| 32 | Miami Valley Hospital South; Dayton Physician's Office | Centerville | Ohio | United States | 45459 |
| 33 | UC Health, LLC. | Cincinnati | Ohio | United States | 45219 |
| 34 | OhioHealth Riverside Methodist Hospital; Pharmacy Services | Columbus | Ohio | United States | 43214 |
| 35 | Providence Brain and Spine Institute | Portland | Oregon | United States | 97225 |
| 36 | Neurology Clinic PC | Cordova | Tennessee | United States | 38018 |
| 37 | Hope Neurology | Knoxville | Tennessee | United States | 37922 |
| 38 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
| 39 | Uni of Texas Health Science Center At Houston | Houston | Texas | United States | 77030 |
| 40 | Texas Institute for Neurological Disorders | Sherman | Texas | United States | 75092 |
| 41 | Evergreen MS Center | Kirkland | Washington | United States | 98034 |
| 42 | Swedish Medical Center | Seattle | Washington | United States | 98104-1360 |
| 43 | West Virginia University | Charleston | West Virginia | United States | 25304 |
| 44 | Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | United States | 53226-3596 |
| 45 | Instituto De Neurología Cognitiva - INECO | Caba | Argentina | C1126AAB | |
| 46 | Instituto de Investigaciones Metabolicas (Idim) | Ciudad Autonoma de Buenos Aires | Argentina | C1012AAR | |
| 47 | Instituto DIABAID | Ciudad Autónoma de Buenos Aires | Argentina | C1061ABD | |
| 48 | Instituto Reumatológico Strusberg | Cordoba | Argentina | X5000EDC | |
| 49 | Fundacion Rosarina de Neurorehabilitacion | Rosario | Argentina | S2000BZL | |
| 50 | Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY | San Miguel | Argentina | T4000AXL | |
| 51 | Brain and Mind Research Institute | Camperdown | New South Wales | Australia | 2050 |
| 52 | St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
| 53 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 54 | John Hunter Hospital | New Lambton | New South Wales | Australia | 2305 |
| 55 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 56 | Box Hill Hospital; Department of Neurology | Box Hill | Victoria | Australia | 3128 |
| 57 | Austin Hospital; Department of Neurology | Heidelberg | Victoria | Australia | 3084 |
| 58 | St Vincents Hospital | Melbourne | Victoria | Australia | 3065 |
| 59 | Royal Melbourne Hospital; Department of Neurology | Parkville | Victoria | Australia | 3050 |
| 60 | Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie | Linz | Austria | 4020 | |
| 61 | Medizinische Universität Wien; Univ.Klinik fuer Neurologie | Wien | Austria | 1090 | |
| 62 | Santa Casa de Misericordia; de Belo Horizonte | Belo Horizonte | MG | Brazil | 30150-221 |
| 63 | Instituto de Neurologia de Curitiba | Curitiba | PR | Brazil | 81210-310 |
| 64 | Hospital Universitario Gaffree e Guinle | Rio de Janeiro | RJ | Brazil | 20270-004 |
| 65 | IMV Pesquisa Neurológica | Porto Alegre | RS | Brazil | 90110-000 |
| 66 | Núcleo de Pesquisa do Rio Grande do Sul | Porto Alegre | RS | Brazil | 90430-001 |
| 67 | Clinica Neurologica; Neurocirurgica de Joinville | Joinville | SC | Brazil | 89202-190 |
| 68 | Centro de Pesquisas Clinicas; CPCLIN | Sao Paulo | SP | Brazil | 01228-200 |
| 69 | UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases | Pleven | Bulgaria | 5800 | |
| 70 | Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD | Sofia | Bulgaria | 1113 | |
| 71 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 1Z1 |
| 72 | Fraser Health Authority - Fraser Health Multiple Sclerosis | Burnaby | British Columbia | Canada | V5G 2X6 |
| 73 | University of British Columbia | Vancouver | British Columbia | Canada | V6T 1Z4 |
| 74 | Regional health authority A vitalite health network | Moncton | New Brunswick | Canada | E1C 8X3 |
| 75 | London Health Sciences Centre Uni Campus | London | Ontario | Canada | N6A 5A5 |
| 76 | The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis | Ottawa | Ontario | Canada | K1H 8L6 |
| 77 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 78 | St. Michael's Hospital; MS Clinic | Toronto | Ontario | Canada | M5B-1W8 |
| 79 | Clinique NeuroOutaouais | Gatineau | Quebec | Canada | J8Y 1W2 |
| 80 | Recherche Sepmus, Inc. | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 81 | Montreal Neurological Institute and Hospital | Montreal | Quebec | Canada | H3A 2B4 |
| 82 | CeCim Biocinetic | Santiago | Chile | 8331143 | |
| 83 | Clinica Alemana | Vitacura | Chile | 0 | |
| 84 | Organizacion Sanitas Internacional | Bogota, D.C. | Colombia | 111321 | |
| 85 | Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas | Cali | Colombia | ||
| 86 | Instituto Neurologico de Colombia INDEC | Medellin | Colombia | ||
| 87 | Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken | Aabenraa | Denmark | 6200 | |
| 88 | Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken | Aarhus N | Denmark | 8200 | |
| 89 | Rigshospitalet; Neurologisk Klinik Glostrup | Glostrup | Denmark | 2600 | |
| 90 | Groupe Hospitalier Pellegrin; Service de neurochirurgie B | Bordeaux | France | 33076 | |
| 91 | Hopital Pierre Wertheimer; Neurologie D | Bron | France | 69677 | |
| 92 | CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie | Montpellier | France | 34295 | |
| 93 | Hopital Guillaume Et Rene Laennec | Nantes | France | 44805 | |
| 94 | Hôpital Pasteur; Service de Neurologie | Nice | France | 06002 | |
| 95 | Hopital Civil de Strasbourg; Service de Neurologie | Strasbourg | France | 67091 | |
| 96 | Charite - Universitatsmedizin Berlin; Klinik fur Neurologie | Berlin | Germany | 10117 | |
| 97 | Studienzentrum für Neurologie und Psychiatrie | Böblingen | Germany | 71034 | |
| 98 | Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Dresden | Germany | 01307 | |
| 99 | Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie | Freiburg | Germany | 79106 | |
| 100 | Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum | München | Germany | 81675 | |
| 101 | Universitaetsklinikum Tuebingen; Abteilung Neurologie | Tuebingen | Germany | 72076 | |
| 102 | Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz | Westerstede | Germany | 26655 | |
| 103 | Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie | Wiesbaden | Germany | 65191 | |
| 104 | 401 Military Hospital of Athens; Neurology Department | Athens | Greece | 115 25 | |
| 105 | AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept. | Thessaloniki | Greece | 546 36 | |
| 106 | Hospital Eginition; First Department of Neurology | Αθηνα | Greece | 115 28 | |
| 107 | Clinexpert Kft. | Budapest | Hungary | 1033 | |
| 108 | Jahn Ferenc Dél-Pesti Kórház | Budapest | Hungary | 1204 | |
| 109 | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | Hungary | 2143 | |
| 110 | Dr. HIBBEY Egeszsegugyi es Szolgaltato Kft | Tatabánya | Hungary | 2800 | |
| 111 | Rambam Medical Center; Neurology Unit | Haifa | Israel | 3109601 | |
| 112 | Hadassah University Hospital - Ein Kerem | Jerusalem | Israel | 9112001 | |
| 113 | The Chaim Sheba Medical Center; Multiple Sclerosis Center | Ramat-Gan | Israel | 5262100 | |
| 114 | Tel Aviv Sourasky Medical Center; Department of Neurology | Tel Aviv | Israel | 6423906 | |
| 115 | AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica | Napoli | Campania | Italy | 80138 |
| 116 | A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti) | Parma | Emilia-Romagna | Italy | 43126 |
| 117 | Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Roma | Lazio | Italy | 00133 |
| 118 | Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari | Milano | Lombardia | Italy | 20133 |
| 119 | Ospedale Civile di Montichiari; Centro Sclerosi Multipla | Montichiari | Lombardia | Italy | 25018 |
| 120 | IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla | Pozzilli | Molise | Italy | 86077 |
| 121 | Mexico Centre for Clinical Research | Ciudad de México | Mexico CITY (federal District) | Mexico | 03100 |
| 122 | Grupo Médico Camino S.C. | Ciudad de México | Mexico CITY (federal District) | Mexico | 03600 |
| 123 | Hospital Juarez de Mexico | Ciudad de México | Mexico CITY (federal District) | Mexico | 07760 |
| 124 | Clinstile S.A de C.V. | Mexico City | Mexico CITY (federal District) | Mexico | 06700 |
| 125 | Clinical Research Institute | Tlalnepantla de Baz | Mexico CITY (federal District) | Mexico | 54055 |
| 126 | Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion | Bellavista | Peru | Callao 2 | |
| 127 | Clinica Internacional; Unidad De Investigacion | Lima | Peru | 15001 | |
| 128 | Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru | Lima | Peru | Lima 01 | |
| 129 | Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | Poland | 85-796 | |
| 130 | Care Clinic | Katowice | Poland | 40-568 | |
| 131 | Specjalistyczny Szpital Sw. Lukasza | Konskie | Poland | 26-200 | |
| 132 | Centrum Neurologii Krzysztof Selmaj | Lodz | Poland | 90-324 | |
| 133 | Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak | Lublin | Poland | 20-605 | |
| 134 | Med Polonia | Poznań | Poland | 60-693 | |
| 135 | Centrum Medyczne "MEDYK" | Rzeszow | Poland | 35-055 | |
| 136 | Nzoz Palomed | Rzeszów | Poland | 35-232 | |
| 137 | NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice Śląskie | Poland | 41-100 | |
| 138 | Centrum Medyczne NeuroProtect | Warszawa | Poland | 01-684 | |
| 139 | Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Warszawa | Poland | 02-957 | |
| 140 | Wro Medica | Wrocław | Poland | 51-685 | |
| 141 | SPSK nr 1; Klinika Neurologii | Zabrze | Poland | 41-800 | |
| 142 | Hospital de Braga; Servico de Neurologia | Braga | Portugal | 4710-243 | |
| 143 | Hospital Santo Antonio dos Capuchos; Servico de Neurologia | Lisboa | Portugal | 1169-050 | |
| 144 | Hospital de Santa Maria; Servico de Neurologia | Lisboa | Portugal | 1649-035 | |
| 145 | Hospital Geral de Santo Antonio; Servico de Neurologia | Porto | Portugal | 4099-001 | |
| 146 | Hospital de Sao Joao; Servico de Neurologia | Porto | Portugal | 4200-319 | |
| 147 | San Juan MS Center | Guaynabo | Puerto Rico | 00968 | |
| 148 | FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Krasnoyarsk | Krasnojarsk | Russian Federation | 660037 |
| 149 | Krasnoyarsk State Medical Academy | Krasnoyarsk | Krasnojarsk | Russian Federation | 660049 |
| 150 | National Center of Social Significant Disease | Sankt-peterburg | Leningrad | Russian Federation | 197110 |
| 151 | Federal center of brain research and neurotechnologies | Moskva | Moskovskaja Oblast | Russian Federation | 117997 |
| 152 | City Clinical Hospital #24; Multipal Sclerosis department | Moskva | Moskovskaja Oblast | Russian Federation | 127015 |
| 153 | Republican Clinical Neurological Center | Kazan | Tatarstan | Russian Federation | 420021 |
| 154 | Sverdlovsk Regional Clinical Hospital 1 | Ekaterinburg | Russian Federation | 620102 | |
| 155 | Kemerovo Regional Clinical Hospital | Kemerovo | Russian Federation | 650066 | |
| 156 | Center of Cardiology and Neurology | Kirov | Russian Federation | 610007 | |
| 157 | FSBIH Siberian Regional Medical Centre of FMBA of Russia | Novosibirsk | Russian Federation | 630007 | |
| 158 | State Novosibirsk Regional Clinical Hospital | Novosibirsk | Russian Federation | 630087 | |
| 159 | Pavlov State Medical Uni ; Neurology | St Petersburg | Russian Federation | 197022 | |
| 160 | City Hospital #40 of Resort Administrative District | St. Petersburg | Russian Federation | 197706 | |
| 161 | Nebbiolo Center for Clinical Trials | Tomsk | Russian Federation | 634009 | |
| 162 | Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology | Tyumen | Russian Federation | 625000 | |
| 163 | Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia | Coruña | LA Coruña | Spain | 15006 |
| 164 | Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología | Lleida | Lerida | Spain | 25198 |
| 165 | Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 166 | Hospital Alvaro Cunqueiro; Servicio de Neurologia | Vigo | Pontevedra | Spain | |
| 167 | Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia | Barcelona | Spain | 08035 | |
| 168 | Hospital Puerta del Mar; Sevicio de Neurologia | Cadiz | Spain | 11009 | |
| 169 | Hospital Ramon y Cajal; Servicio de Neurologia | Madrid | Spain | 28034 | |
| 170 | Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia | Malaga | Spain | 29010 | |
| 171 | Hospital Universitario Virgen Macarena; Servicio de Neurologia | Sevilla | Spain | 41009 | |
| 172 | Universitätsspital Basel; Neurologie | Basel | Switzerland | 4031 | |
| 173 | Inselspital Bern Medizin Neurologie | Bern | Switzerland | 3010 | |
| 174 | UniversitätsSpital Zürich; Klinik für Neurologie | Zürich | Switzerland | 8091 | |
| 175 | Hacettepe University Medical Faculty; Neurology | Ankara | Turkey | 06100 | |
| 176 | Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali | Istanbul | Turkey | 34098 | |
| 177 | Sancaktepe Training and Research Hospital; Neurology | Istanbul | Turkey | 34785 | |
| 178 | Kocaeli University Hospital; Department of Neurology | Kocaeli | Turkey | 41380 | |
| 179 | Selcuk University Medical Faculty; Norology department | Konya | Turkey | 42131 | |
| 180 | Mersin University Medical Faculty; Neurology | Mersin | Turkey | 33079 | |
| 181 | Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | Turkey | 55139 | |
| 182 | Karadeniz Tecnical Uni. Med. Fac.; Neurology | Trabzon | Turkey | 61080 | |
| 183 | CNPE City Clinical Hospital #3 of Chernivtsi City Council | Chernivtsi | Chernihiv Governorate | Ukraine | 58022 |
| 184 | MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care | Lviv | Chernihiv Governorate | Ukraine | 79007 |
| 185 | Medical Centre of PE First Private Clinic | Zhytomir | Crimean Regional Governmenta | Ukraine | 10008 |
| 186 | Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1 | Dnipro | Katerynoslav Governorate | Ukraine | 49005 |
| 187 | Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | Kharkiv Governorate | Ukraine | 61058 |
| 188 | Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporizhzhia | Kharkiv Governorate | Ukraine | 69600 |
| 189 | MEDBUD | Kyiv | KIEV Governorate | Ukraine | 03037 |
| 190 | Lviv Regional Clinical Hospital | Lviv | KIEV Governorate | Ukraine | 79010 |
| 191 | Salutem Medical Center | Vinnytsia | KIEV Governorate | Ukraine | 21050 |
| 192 | Medical Clinical Research Center of Medical Center LLC Health Clinic | Vinnytsia | Podolia Governorate | Ukraine | 21009 |
| 193 | Regional Clinical Hospital; Neurology Department | Ivano-Frankivsk | Ukraine | 76008 | |
| 194 | Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology | Kharkov | Ukraine | 61068 | |
| 195 | Volyn Regional Clinical Hospital | Lutsk | Ukraine | 43024 | |
| 196 | Odesa Regional Clinical Hospital; Neurosurgery Department | Odesa | Ukraine | 65117 | |
| 197 | Charing Cross Hospital | London | United Kingdom | W6 8RF | |
| 198 | Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom | NG7 2UH | |
| 199 | Derriford Hospital | Plymouth | United Kingdom | PL6 8DH |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04544449
Other Study ID Numbers:
- GN41791
- 2019-003919-53
First Posted:
Sep 10, 2020
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: