Исследование оценки эффективности, безопасности и фармакокинетики более высоких доз окрелизума у ​​взрослых с первичным прогрессирующим рассеянным склерозом (PPMS)

Название протокола
Клинические исследование Рассеянный склероз: Ocrelizumab, Окрелизумаб, Intervenção do microrganismo intestinal no comprometimento cognitivo leve, Метилпреднизолон - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Hoffmann-La Roche

Источник Hoffmann-La Roche
Краткое содержание

Это рандомизированное двойное контролируемое многоцентровое исследование с параллельными группами оценки эффективность, безопасность и фармакокинетика более высокой дозы окрелизумаба при внутривенном (в / в) введении инфузия каждые 24 недели участникам с ППМС, по утвержденной дозой 600 мг окрелизумаба.

Подробное описание

Участники будут проходить лечение в течение как минимум 120 недель в двойной слепой фазе. На положительные первичные результаты после двойной слепой фазы, необязательное увеличение дозы лечение (фаза OLE) планируется для подходящих участников. OLE будет продуктом для примерно 96 недель. После этого участники будут находиться под наблюдением в течение 48 недель. Уровни B-клеток все еще не достигли исходного уровня или ниже предел нормы (LLN), в зависимости от того, что ниже, перейдет в фазу мониторинга B-клеток (BCM) после этапа проверки безопасности. Исследование закончится, когда все участники, которые не были леченные альтернативной терапией истощения B-клеток, пополнили свои B-клетки до базовое значение или нижняя граница нормы.

Общий статус Рекрутинг
Дата начала 2020-12-03
Дата завершения 2028-09-01
Дата первичного завершения 2024-11-29
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Вторичный результат
Мера Временное ограничение
Time to Onset of 24-week cCDP (cCDP24) Baseline up to approximately 4.3 years
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve
Регистрация 699
Состояние
  • Рассеянный склероз
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Ocrelizumab

Описание: The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.

Этикетка Arm Group: Ocrelizumab Higher Dose

Другое имя: Ocrevus

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Окрелизумаб

Описание: Окрелизумаб будет вводиться в дозе 600 миллиграмм (мг) каждые 24 недели. Первую дозу окрелизумаба вводят в виде двух внутривенных (IV) инфузий по 300 мг с интервалом 14 дней. Для первого доз окрелизумаб будет вводиться в виде однократной внутривенной инфузии 600 мг каждые 24 недели.

Этикетка Arm Group: Утвержденная доза окрелизумаба

Другое имя: Окревус

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Описание: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Другое имя: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Метилпреднизолон

Описание: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Другое имя: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Приемлемость

Критерии:

Intervenção do microrganismo intestinal no comprometimento cognitivo leve Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

55 лет

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Clinical Trials Study Director Hoffmann-La Roche
Общий контакт

Фамилия: Reference Study ID Number: BN42083 www.roche.com/about_roche/roche_worldwide.htm

Телефон: 888-662-6728 (U.S. and Canada)

Расположение
Объект: Положение дел:
Alabama Neurology Associates | Homewood, Alabama, 35209, United States Recruiting
21st Century Neurology | Phoenix, Arizona, 85004, United States Recruiting
Center for Neurosciences | Tucson, Arizona, 85718, United States Recruiting
University of Arkansas For Medical Sciences | Little Rock, Arkansas, 72205, United States Not yet recruiting
University of California Irvine | Irvine, California, 92617, United States Not yet recruiting
SC3 Research Group, Inc | Pasadena, California, 91105, United States Not yet recruiting
University of California Davis Health System; Department of Neurology | Sacramento, California, 95817, United States Recruiting
Stanford University Medical Center; Stanford Neuroscience Health Center | Stanford, California, 94305, United States Recruiting
Los Angeles Biomedical Research Institute at Harbor-UCLA | Torrance, California, 90502, United States Recruiting
University of Colorado Denver | Aurora, Colorado, 80045, United States Recruiting
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C. | Basalt, Colorado, 81621, United States Active, not recruiting
Colorado Neurological Institute | Englewood, Colorado, 80113, United States Withdrawn
Advanced Neurosciences Research LLC | Fort Collins, Colorado, 80524, United States Not yet recruiting
KI Health Partners, LLC; New England Institute for Clinical Research | Stamford, Connecticut, 06905, United States Recruiting
SFM Clinical Research, LLC | Boca Raton, Florida, 33487, United States Recruiting
MS and Neuromuscular Center of Excellence | Clearwater, Florida, 33761, United States Recruiting
Elite Clinical Research | Miami, Florida, 33144, United States Not yet recruiting
Infinity Clinical Research, LLC | Sunrise, Florida, 33351, United States Recruiting
Axiom Clinical Research of Florida | Tampa, Florida, 33609, United States Recruiting
University of South Florida | Tampa, Florida, 33612, United States Recruiting
University of Chicago Hospital | Chicago, Illinois, 60637, United States Not yet recruiting
Baptist Health Lexington | Nicholasville, Kentucky, 40356, United States Not yet recruiting
Maine Medical Center | Scarborough, Maine, 04074, United States Recruiting
International Neurorehabilitation Institute | Lutherville, Maryland, 21093, United States Recruiting
Massachusetts General Hospital. | Boston, Massachusetts, 02114, United States Not yet recruiting
Neuro Institute of New England P.C.; Research | Foxboro, Massachusetts, 02035, United States Recruiting
Dragonfly Research, LLC | Wellesley, Massachusetts, 02481, United States Recruiting
University of Massachusetts Medical School | Worcester, Massachusetts, 01655, United States Recruiting
Michigan Institute for Neurological Disorders | Farmington Hills, Michigan, 48334, United States Recruiting
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis | Owosso, Michigan, 48867, United States Recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting
The MS Center for Innovations In Care | Saint Louis, Missouri, 63131, United States Not yet recruiting
Jersey Shore University Medical Centre | Neptune, New Jersey, 07753, United States Not yet recruiting
Northwell Health | Great Neck, New York, 11021, United States Recruiting
Lenox Hill Hospital | New York, New York, 10075, United States Recruiting
Atrium Health Neurosciences Institute - Charlotte | Charlotte, North Carolina, 28204, United States Recruiting
University of Cincinnati; Department of Neurology | Cincinnati, Ohio, 45267, United States Recruiting
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting
OhioHealth Research Institute | Columbus, Ohio, 43214, United States Recruiting
Premier Neurology | Greer, South Carolina, 29650, United States Recruiting
Neurology Clinic PC | Cordova, Tennessee, 38018, United States Recruiting
Wesley Neurology Clinic | Cordova, Tennessee, 38018, United States Withdrawn
New Orleans Center for Clinical Research | Knoxville, Tennessee, 37920, United States Recruiting
Advanced Neurosciences Institute | Nashville, Tennessee, 37205, United States Recruiting
University of Texas Southwestern Medical Center | Dallas, Texas, 75390, United States Not yet recruiting
Baylor College of Medicine | Houston, Texas, 77030, United States Recruiting
Neurology Center of San Antonio | San Antonio, Texas, 78212, United States Recruiting
Texas Institute for Neurological Disorders | Sherman, Texas, 75092, United States Recruiting
Meridian Clinical Research | Norfolk, Virginia, 23502, United States Withdrawn
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders | Milwaukee, Wisconsin, 53215, United States Recruiting
CEMIC Saavedra | Buenos Aires, 1431, Argentina Recruiting
Instituto DIABAID | Ciudad Autónoma de Buenos Aires, C1061ABD, Argentina Active, not recruiting
INECO; Neurociencias | Rosario, 1921, Argentina Active, not recruiting
CH EpiCURA Site Ath | Ath, 7800, Belgium Not yet recruiting
Revalidatie en MS Centrum | Overpelt, 3900, Belgium Recruiting
L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar | Brasilia, DF, 70200-730, Brazil Recruiting
Hospital das Clinicas - UFG | Goiania, GO, 74605-020, Brazil Recruiting
Instituto de Neurologia de Curitiba | Curitiba, PR, 81210-310, Brazil Recruiting
Instituto Méderi de Pesquisa e Saúde | Passo Fundo, RS, 99010-120, Brazil Not yet recruiting
Hospital Moinhos de Vento | Porto Alegre, RS, 90035-001, Brazil Recruiting
IMV Pesquisa Neurológica | Porto Alegre, RS, 90110-000, Brazil Recruiting
Hospital Sao Lucas - PUCRS | Porto Alegre, RS, 90610-000, Brazil Recruiting
Clinica Neurologica; Neurocirurgica de Joinville | Joinville, SC, 89202-190, Brazil Recruiting
Hospital das Clinicas - UNICAMP | Campinas, SP, 13083-888, Brazil Recruiting
Praxis Pesquisa Médica | Santo Andre, SP, 09090-790, Brazil Recruiting
CPQuali Pesquisa Clinica Ltda | Sao Paulo, SP, 01228-000, Brazil Recruiting
Hospital das Clinicas - FMUSP | Sao Paulo, SP, 05403-900, Brazil Recruiting
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases | Pleven, 5800, Bulgaria Recruiting
MHATNP Sveti Naum EAD | Sofia, 1113, Bulgaria Recruiting
University of British Columbia | Vancouver, British Columbia, V6T 1Z4, Canada Withdrawn
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital | Chicoutimi, Quebec, G7H 5H6, Canada Not yet recruiting
Chum Campus Notre Dame | Montreal, Quebec, H2X 0A9, Canada Not yet recruiting
MUCH - Montreal Neurological Institute & Hospital | Montreal, Quebec, H3A 2B4, Canada Not yet recruiting
Hotel-Dieu de Levis | Quebec, G1W 4R4, Canada Recruiting
Fakultni nemocnice u sv. Anny; Neurologicka klinika | Brno, 656 91, Czechia Withdrawn
Fakultni nemocnice Ostrava; MS centrum | Ostrava-Poruba, 708 52, Czechia Withdrawn
Vseobecna fakultni nemocnice v Praze | Praha 2, 12808, Czechia Withdrawn
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb. | Aalborg, 9000, Denmark Recruiting
Rigshospitalet Glostrup; Neurologisk Klinik | Glostrup, 2600, Denmark Recruiting
Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken | Odense C, 5000, Denmark Withdrawn
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie | Besançon, 25030, France Recruiting
CHU Brest Hopital La Cavale Blanche; Neurologie | Brest, 29609, France Recruiting
Hopital Pierre Wertheimer; Neurologie D | Bron, 69677, France Recruiting
Hopital Cote De Nacre; Unite Neurologie Generale | Caen, 14033, France Recruiting
CHU Hopital Gabriel Montpied; Service de Neurologie | Clermont Ferrand, 63003, France Recruiting
CH St Vincent de Paul | Lille, 59000, France Recruiting
Hopital Central - CHU de Nancy; Service de Neurologie | Nancy, 54035, France Not yet recruiting
Hopital Hautepierre - CHU Strasbourg; Service de Neurologie | Strasbourg, 67098, France Recruiting
Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc | Bonn, 53111, Germany Recruiting
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Dresden, 01307, Germany Recruiting
Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie | Greifswald, 17475, Germany Recruiting
Universitätsmedizin Göttingen Georg-August-Universität | Göttingen, 37075, Germany Not yet recruiting
Krankenhaus Martha-Maria Hallo-Dölau, Klinik für Neurologie | Halle (Saale), 06120, Germany Not yet recruiting
Medizinische Hochschule Hannover, Klinik für Neurologie | Hannover, 30625, Germany Recruiting
Universitätsklinikum Jena, Klinik für Neurologie | Jena, 07747, Germany Recruiting
Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie | Kiel, 24105, Germany Recruiting
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie | Leipzig, 04103, Germany Recruiting
Universitaetsklinikum Marburg; Klinik fuer Neurologie | Marburg, 35043, Germany Recruiting
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie | Münster, 48149, Germany Recruiting
Praxis Dr. med. Bergmann | Neuburg, 86633, Germany Withdrawn
Neurozentrum Stuttgart Mitte Sophienstraße; Neurologische Gemeinschaftspraxis | Stuttgart, 70178, Germany Withdrawn
Krankenhaus der Barmherzigen Brüder Trier; Neurologie, Neurophysiol. neurolog.Reha/Schlaganfalleinh | Trier, 54292, Germany Not yet recruiting
Universitätsklinikum Tübingen, Zentrum für Neurologie | Tübingen, 72076, Germany Recruiting
Universitätsklinikum Ulm; Klinik für Neurologie | Ulm, 89081, Germany Recruiting
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie | Wiesbaden, 65191, Germany Recruiting
401 Military Hospital of Athens; Neurology Department | Athens, 115 25, Greece Recruiting
University General Hospital of Larisa; Neurology Clinic | Larisa, 411 10, Greece Recruiting
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept. | Thessaloniki, 546 36, Greece Recruiting
Hospital Eginition; First Department of Neurology | Αθηνα, 115 28, Greece Recruiting
UNO Medical Trials Kft. | Budapest, 1135, Hungary Recruiting
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology | Budapest, 1145, Hungary Recruiting
Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly | Gyor, 9024, Hungary Recruiting
Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology | Kaposvár, 7400, Hungary Recruiting
Pest Megyei Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary Not yet recruiting
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche | Napoli, Campania, 80131, Italy Recruiting
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica | Napoli, Campania, 80138, Italy Not yet recruiting
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico | Roma, Lazio, 00152, Italy Recruiting
Azienda Ospedaliera Sant'Andrea; UOC Neurologia | Roma, Lazio, 00189, Italy Not yet recruiting
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla | Bergamo, Lombardia, 24127, Italy Recruiting
Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico | Gallarate, Lombardia, 21013, Italy Not yet recruiting
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla | Milano, Lombardia, 20132, Italy Recruiting
IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla | Pavia, Lombardia, 27100, Italy Recruiting
AOU Città della Salute e della Scienza; Neurologia 1 | Torino, Piemonte, 10126, Italy Recruiting
Ospedale Binaghi; Centro Sclerosi Multipla | Cagliari, Sardegna, 09126, Italy Withdrawn
AOU Senese; UOC Clinica Neurologica e Malattie neurometaboliche | Siena, Toscana, 53100, Italy Recruiting
Grupo Médico Camino S.C. | Ciudad de México, Mexico CITY (federal District), 03600, Mexico Recruiting
Clinstile S.A de C.V. | Mexico City, Mexico CITY (federal District), 06700, Mexico Recruiting
Neurociencias Prisma, A.C | San Luis Potosí, SAN LUIS Potosi, 78216, Mexico Not yet recruiting
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. | Guadalajara, 44130, Mexico Recruiting
Hospital Nacional Guillermo Almenara Irigoyen | La Victoria, Lima, Lima 13, Peru Not yet recruiting
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia | Lima, 15003, Peru Recruiting
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru | Lima, Lima 01, Peru Recruiting
Clinica Sanchez Ferrer | Trujillo, 13009, Peru Not yet recruiting
Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz, 85-796, Poland Recruiting
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny | Gdansk, 80-803, Poland Recruiting
M.A. - LEK A.M.Maciejowscy SC. | Katowice, 40-595, Poland Recruiting
Specjalistyczny Szpital Sw. Lukasza | Konskie, 26-200, Poland Recruiting
Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu | Krakow, 31-637, Poland Recruiting
Centrum Neurologii Krzysztof Selmaj | Lodz, 90-324, Poland Recruiting
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin, 20-016, Poland Recruiting
Wojewodzki Szpital Specjalistyczny | Olsztyn, 10-561, Poland Recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. | Oswiecim, 32-600, Poland Recruiting
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych | Plewiska, 62-064, Poland Recruiting
EMC Instytut Medyczny SA | Poznań, 60-309, Poland Recruiting
Wojewódzki Szpital Specjalistyczny Nr 3 | Rybnik, 44-200, Poland Recruiting
Nzoz Palomed | Rzeszów, 35-232, Poland Recruiting
NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice Śląskie, 41-100, Poland Recruiting
Osrodek Badan Klinicznych Euromedis | Szczecin, 70-111, Poland Recruiting
Centrum Medyczne NeuroProtect | Warszawa, 01-684, Poland Active, not recruiting
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Warszawa, 02-957, Poland Recruiting
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON | Warszawa, 04-141, Poland Recruiting
Hospital Garcia de Orta; Servico de Neurologia | Almada, 2801-951, Portugal Not yet recruiting
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E) | Braga, 4710-243, Portugal Recruiting
Hospital Santo Antonio dos Capuchos; Servico de Neurologia | Lisboa, 1169-050, Portugal Recruiting
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia | Lisboa, 1349-019, Portugal Recruiting
Hospital Geral de Santo Antonio; Servico de Neurologia | Porto, 4099-001, Portugal Recruiting
Centro Hospitalar de Setubal, EPE - Hospital São Bernardo; Serviço de Neurologia | Setúbal, 2910-446, Portugal Not yet recruiting
San Juan MS Center | Guaynabo, 968, Puerto Rico Recruiting
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Krasnoyarsk, Krasnojarsk, 660037, Russian Federation Recruiting
National Center of Social Significant Disease | Sankt-peterburg, Leningrad, 197110, Russian Federation Recruiting
Research Center of Neurology of RAMS | Moscow, Moskovskaja Oblast, 125367, Russian Federation Recruiting
FGBU Federal Center of cerebrovascular pathology and stroke | Moskva, Moskovskaja Oblast, 117997, Russian Federation Recruiting
City Clinical Hospital #24; Multipal Sclerosis department | Moskva, Moskovskaja Oblast, 127015, Russian Federation Recruiting
N.P. Bechtereva Institute of the Human Brain | Sankt-petersburg, Sankt Petersburg, 197376, Russian Federation Recruiting
City Hospital #40 of Kurortniy Administrative District | St. Petersburg, Sankt Petersburg, 197706, Russian Federation Recruiting
Ulyanovsk Regional Clinical Hospital | Ulyanovsk, Uljanovsk, 432063, Russian Federation Recruiting
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology | Ekaterinburg, 620102, Russian Federation Recruiting
State Autonomous Healthcare Institution "Republican Clinical Neurological Center | Kazan, 420021, Russian Federation Recruiting
Center of Cardiology and Neurology | Kirov, 610007, Russian Federation Recruiting
Regional clinical hospital named after prof. S.V. Ochapovsky | Krasnodar, 350086, Russian Federation Recruiting
Krasnoyarsk State Medical Academy | Krasnoyarsk, 660022, Russian Federation Recruiting
FSBIH Siberian Regional Medical Centre of FMBA of Russia | Novosibirsk, 630007, Russian Federation Recruiting
Perm Regional Clinical Hospital of Znak Pocheta Medal | Perm, 614990, Russian Federation Not yet recruiting
Leningrad Regional Clinical Hospital | St Petersburg, 194291, Russian Federation Recruiting
SBEI of HPE "Bashkir State Medical University" of MoH RF | Ufa, 450000, Russian Federation Not yet recruiting
Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcon, Madrid, 28223, Spain Active, not recruiting
Hospital Vall de Hebrón; Servicio de Neurologia. Centre d'Esclerosi Multiple de Catalunya CEMCAT | Barcelona, 8035, Spain Recruiting
Hospital Universitario Puerta de Hierro; Servicio de Neurologia | Madrid, 28222, Spain Recruiting
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología | Murcia, Spain Recruiting
Kantonsspital Aarau AG; Neurologie | Aarau, 5001, Switzerland Recruiting
Inselspital-Universitaetsspital Bern; Neurologische Poliklinik | Bern, 3010, Switzerland Recruiting
Ospedale Regionale di Lugano - Civico; Neurologia | Lugano, 6903, Switzerland Recruiting
Gazi University Medical Faculty | Ankara, 06500, Turkey Recruiting
Haseki Training and Research Hospital; Department of Neurology | Istanbul, 34096, Turkey Recruiting
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali | Istanbul, 34098, Turkey Recruiting
Sancaktepe Training and Research Hospital; Neurology | Istanbul, 34785, Turkey Recruiting
Erciyes Universitesi; Pediatric Neurology | Kayseri, 38039, Turkey Recruiting
Kocaeli University Hospital; Department of Neurology | Kocaeli, 41380, Turkey Recruiting
Selcuk University Medical Faculty; Norology department | Konya, 42131, Turkey Recruiting
Ege Üniversitesi Tip Fakültesi | Lzmir, 35100, Turkey Recruiting
Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu | Merkez, 58060, Turkey Recruiting
Mersin University Medical Faculty; Neurology | Mersin, 33079, Turkey Recruiting
Ondokuz Mayis University School of Medicine; Neurology | Samsun, 55239, Turkey Recruiting
Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu | Çankaya, 06490, Turkey Recruiting
Medical Center Dopomoga Plus | Kyiv, Chernihiv Governorate, 02123, Ukraine Recruiting
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council | Zaporizhzhia, Katerynoslav Governorate, 69600, Ukraine Recruiting
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv, Kharkiv Governorate, 61058, Ukraine Recruiting
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine | Kharkiv, Kharkiv Governorate, 61068, Ukraine Recruiting
Medical Center of Private Execution First Private Clinic | Kyiv, KIEV Governorate, 03037, Ukraine Active, not recruiting
Lvivska oblasna tsentralna likarnia | Lviv, KIEV Governorate, 79010, Ukraine Recruiting
Medical Clinical Research Center of Medical Center LLC Health Clinic | Vinnytsia, Podolia Governorate, 21009, Ukraine Recruiting
Sumy Regional Clinical Hospital | Sumy, Polissya Okruha, 40031, Ukraine Recruiting
Lytvynenko Clinic | Poltava, Poltava Governorate, 36000, Ukraine Not yet recruiting
Miska Klinichna Likarnia №16 | Dnipropetrovsk, Tavria Okruha, 49100, Ukraine Recruiting
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkasy, 18009, Ukraine Recruiting
Regional Clinical Hospital; Neurology Department | Ivano-Frankivsk, 76008, Ukraine Recruiting
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis | Kharkov, 61068, Ukraine Recruiting
Volyn Regional Clinical Hospital | Lutsk, 43024, Ukraine Recruiting
University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom Withdrawn
University Hospital Coventry | Coventry, CV2 2DX, United Kingdom Not yet recruiting
Charing Cross Hospital | London, W6 8RF, United Kingdom Not yet recruiting
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases | London, WC1 3BG, United Kingdom Recruiting
Royal Victoria Infirmary | Newcastle upon Tyne, NE1 4LP, United Kingdom Not yet recruiting
University of Nottingham | Nottingham, NG7 2UH, United Kingdom Withdrawn
Derriford Hospital | Plymouth, PL6 8DH, United Kingdom Recruiting
Royal Hallamshire Hospita | Sheffield, S10 2JF, United Kingdom Not yet recruiting
Расположение Страны

Argentina

Belgium

Brazil

Bulgaria

Canada

Czechia

Denmark

France

Germany

Greece

Hungary

Italy

Mexico

Peru

Poland

Portugal

Puerto Rico

Russian Federation

Spain

Switzerland

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2021-09-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Ocrelizumab Higher Dose

Тип: Experimental

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

Метка: Утвержденная доза окрелизумаба

Тип: Активный компаратор

Описание: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Двойник (участник, исследователь)