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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517980-22-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab Test Formulation | Experimental | Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase. |
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| Ocrelizumab Reference Formulation | Active Comparator | Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab Test Formulation | Drug | Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab | Up to 12 weeks | |
| Maximum Serum Concentration (Cmax) of Ocrelizumab | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 168 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CN45320 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profound Research, LLC | Recruiting | Carlsbad | California | 92011 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Ocrelizumab Reference Formulation | Drug | Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm. |
|
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| Advanced Neurology of Colorado, LLC |
| Recruiting |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Neurology Associates PA | Recruiting | Maitland | Florida | 32751 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
| Johns Hopkins University School Of Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
| University of Massachusetts Medical School | Recruiting | Worcester | Massachusetts | 01605 | United States |
| SUNY Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
| Hope Neurology | Recruiting | Knoxville | Tennessee | 37922 | United States |
| Swedish Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR | Recruiting | CABA | Buenos Aires | C1424BYD | Argentina |
| Focus CECIC | Recruiting | CABA | CABA / Buenos Aires | C1425BKU | Argentina |
| INECO Neurociencias Orono | Recruiting | Rosario | Santa Fe Province | S2000DTC | Argentina |
| IME - Instituto Médico Especializado | Recruiting | Buenos Aires | C1405BCH | Argentina |
| Centro de Investigacion en Enfermedades Reumaticas CIER | Recruiting | Ciudad Autonoma Buenos Aires | C1055AAF | Argentina |
| Sanatorio del Sur S.A. | Recruiting | San Miguel de Tucumán | T4000IDK | Argentina |
| Santa Casa de Misericordia de Salvador | Recruiting | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Freire Pesquisa Clinica | Withdrawn | Belo Horizonte | Minas Gerais | 30150 | Brazil |
| Instituto de Neurologia de Curitiba | Recruiting | Curitiba | Paraná | 81210-310 | Brazil |
| Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda | Recruiting | Porto Alegre | Rio Grande do Sul | 90110-000 | Brazil |
| Núcleo de Pesquisa do Rio Grande do Sul | Withdrawn | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Instituto do Cerebro do Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica Neurológica e Neurocirúrgica de Joinville | Recruiting | Joinville | Santa Catarina | 89202-165 | Brazil |
| Centro de Pesquisas Clinicas - CPCLIN | Recruiting | São Paulo | São Paulo | 01244-030 | Brazil |
| Hôpital Guillaume et René Laënnec | Recruiting | Nantes | 44805 | France |
| CHU de Nimes - Hopital Universitaire Caremeau | Recruiting | Nîmes | 30900 | France |
| Hopital Hautepierre - CHU Strasbourg | Recruiting | Strasbourg | 67098 | France |
| Charite - Universitätsmedizin Berlin | Recruiting | Berlin | 12203 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Recruiting | Bochum | 44791 | Germany |
| Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Recruiting | Dresden | 01307 | Germany |
| Universitätsklinikum Tübingen, Zentrum für Neurologie | Recruiting | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
| AO.U. Policlinico Riuniti Foggia | Recruiting | Foggia | Apulia | 71100 | Italy |
| AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2 | Recruiting | Naples | Campania | 80131 | Italy |
| Università degli studi della Campania Luigi Vanvitelli | Recruiting | Naples | Campania | 80138 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Recruiting | Rome | Lazio | 00133 | Italy |
| NCL Institute Neuroscience | Recruiting | Rome | Lazio | 00178 | Italy |
| Fond. Istituto Neurologico C.Besta | Recruiting | Milan | Lombardy | 20133 | Italy |
| IRCCS Istituto Neurologico Neuromed | Recruiting | Pozzilli | Molise | 86077 | Italy |
| Clinstile S.A de C.V. | Recruiting | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Inovacion y Desarrollo en ciencias de la salud | Recruiting | Mexico City | Mexico CITY (federal District) | 14090 | Mexico |
| Neurociencias Prisma, A.C | Recruiting | San Luis Potosí City | San Luis Potosí | 78216 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Recruiting | Culiacán | Sinaloa | 80020 | Mexico |
| ProNeuro Centrum Medyczne | Recruiting | ?ory | 44-240 | Poland |
| Neurocentrum Bydgoszcz sp z o.o | Recruiting | Bydgoszcz | 85-796 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Recruiting | Lodz | 90-324 | Poland |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. | Withdrawn | Oświęcim | 32-600 | Poland |
| Nmedis sp. z o.o. | Recruiting | Rzeszów | 35-323 | Poland |
| IBISMED Wielospecjalistyczne Centrum Medyczne | Recruiting | Zabrze | 41-800 | Poland |
| Hospital de Gran Canaria Dr. Negrín | Recruiting | Las Palmas de Gran Canaria | LAS Palmas | 35010 | Spain |
| Hospital Universitario Virgen de Arrixaca | Recruiting | EL Palmar (EL Palmar) | Murcia | 30120 | Spain |
| Hospital General Universitario de Albacete | Recruiting | Albacete | DUMMY_VALUE | Spain |
| Hospital General Universitario de Alicante | Recruiting | Alicante | 03010 | Spain |
| Hospital Universitari Vall dHebron (CEMCAT) | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario de la Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41007 | Spain |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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