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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001313-93 | EudraCT Number | ||
| 2023-506429-13-00 | EU Trial (CTIS) Number |
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This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Ocrelizumab will be administered via intravenous (IV) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with No Evidence of Progression (NEP) | NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (confirmed disability progression [CDP]; ≥20% increase in timed 25-foot walk test [T25FWT]; ≥20% increase in nine-hole peg test [9HPT]) | From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192 |
| Proportion of Participants with no evidence of progression and no active disease (NEPAD) | NEPAD is defined as no progression sustained for at least 24 weeks on all of the three components of NEP (CDP, T25FWT, 9HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd+)-enhancing lesion | From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT) | Baseline to end of study (Week 192) | |
| Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R) | Baseline to end of study (Week 192) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions Related to General Health:
Exclusions Related to Laboratory Findings:
Exclusions Related to Medications:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Center of California | Laguna Hills | California | 92653 | United States | ||
| SC3 Research Group, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40258203 | Derived | Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21. |
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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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|
| Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study | Baseline to end of study (Week 192) |
| Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks | Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks |
| Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks | Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks |
| Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks | Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks |
| Proportion of Participants with NEP | Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192 |
| Proportion of Participants with NEPAD | Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192 |
| Change from Baseline in Patient-Reported Outcomes (PROs) | PROs collected in this study will be the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking scale (MSWS-12), the ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive function (FSMC), SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale (MSSS-88), Numerical Pain Rating Scale (NPRS), and the Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive function | Baseline to end of study (Week 192) |
| Change from Baseline in the number of falls and near-falls | Baseline to end of study (Week 192) |
| Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter, Deep grey matter) | Baseline to end of study (Week 192) |
| Change in thalamic volumes | Baseline to end of study (Week 192) |
| Change in whole and regional cerebellar volume (cervical cord grey and white matter area) | Baseline to end of study (Week 192) |
| Change in cervical cord cross-sectional area (total, white matter and grey matter) | Baseline to end of study (Week 192) |
| Change in number of new/enlarging T2 lesions and total T2 Lesion Volume | Baseline to end of study (Week 192) |
| Change in number of T1 Gadolinium (Gd)+ Lesions and total volume | 'Baseline to end of study (Week 192) |
| Change in number of T1 lesions | Baseline to end of study (Week 192) |
| Number in total volume of T1 lesions | Baseline to end of study (Week 192) |
| Change in Slowly Evolving Lesions (SEL) | Baseline to end of study (Week 192) |
| Change in normalised T1 intensity/T1 Gd+ enhancement in New Focal T2 Lesions, SELs, Persistent Areas of Non-SEL T2 Lesions, and Normal-Appearing Brain Tissue | Baseline to end of study (Week 192) |
| Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions | Baseline to end of study (Week 192) |
| Change in the number/ spatial distribution of lesions in the cervical spinal cord | Baseline to end of study (Week 192) |
| Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine | Only in centers with 1.5-Tesla MRI capable to perform it | Baseline to end of study (Week 192) |
| Measure of phase rim lesions using a Susceptibility-Weighted Imaging [SWI]/T2 sequence | Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow | Baseline to end of study (Week 192) |
| Percentage of Participants with Adverse Events (AEs) | Baseline to end of study (Week 192) |
| Rates of study treatment discontinuation due to adverse events | Baseline to Week 192 |
| Pasadena |
| California |
| 91105 |
| United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Yale University | North Haven | Connecticut | 06473 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| University of Chicago | Chicago | Illinois | 60637-1470 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | United States |
| Wayne State University School of Medicine | Detroit | Michigan | 48210 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The MS Center of Northeastern New York | Latham | New York | 12110 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Mellen Center | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| Lone Star Neurology of San Antonio | San Antonio | Texas | 78258 | United States |
| Swedish Multiple Sclerosis Center | Seattle | Washington | 98122 | United States |
| University Clinical Center of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| University Hospital Mostar | Mostar | 88000 | Bosnia and Herzegovina |
| Clinical Center University of Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| University Clinical Center Tuzla | Tuzla | 75000 | Bosnia and Herzegovina |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clínicas Faculdades Médicas de Ribeirão Preto | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Hospital das Clinicas - FMUSP_X | São Paulo | São Paulo | 05403-000 | Brazil |
| Fraser Health Authority - Fraser Health Multiple Sclerosis | Burnaby | British Columbia | V5G 2X6 | Canada |
| University of British Columbia Hospital | Vancouver | British Columbia | V6T 2B5 | Canada |
| London Health Sciences Centre Uni Campus | London | Ontario | N6A 5A5 | Canada |
| St. Michael'S Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2L 4M1 | Canada |
| Saskatoon City Hospital | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
| Organizacion Sanitas Internacional | Bogotá | Colombia |
| Fundacion Clinica Valle del Lili | Cali | Colombia |
| Hospital Clínica Biblica | San José | 10101 | Costa Rica |
| Nemocnice Jihlava | Jihlava | 58633 | Czechia |
| Fakultní Nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Rigshospitalet | Glostrup Municipality | 2600 | Denmark |
| Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken | Sønderborg | 6400 | Denmark |
| Clinical Research Center-Alex university | Alexandria | 21561 | Egypt |
| Neurology Department, Ain Shams University Hospitals | Cairo | 11566 | Egypt |
| CHIC Cote Basque Bayonne | Bayonne | 64109 | France |
| Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| Hopital neurologique Pierre Wertheimer - CHU Lyon | Bron | 69677 | France |
| CHU De Caen | Caen | 14033 | France |
| Hopital Gabriel Montpied CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Hopital B Roger Salengro | Lille | 59037 | France |
| CHU de la Timone - Hopital d Adultes | Marseille | 13005 | France |
| Hopital Gui de Chauliac | Montpellier | 34295 | France |
| CHRU Nancy | Nancy | 54035 | France |
| Hopital Nord Laennec | Nantes | 44093 | France |
| Hôpital Pasteur | Nice | 06002 | France |
| GroupeHospitalo-Universitaire Caremeau | Nîmes | 30029 | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
| CHU Amiens Hopital Sud | Salouël | 80480 | France |
| Hopitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Dresden | 01307 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| NeuroConcept AG C/O mind mvz GmbH | Stuttgart | 70182 | Germany |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH | Ulm | 89073 | Germany |
| Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz | Westerstede | 26655 | Germany |
| Deutsche Klinik für Diagnostik | Wiesbaden | 65191 | Germany |
| Nucare | Guatemala City | 01015 | Guatemala |
| Semmelweis Egyetem AOK | Budapest | 1083 | Hungary |
| VALEOMED Diagnosztikai Központ | Esztergom | 2500 | Hungary |
| Jósa András Oktatókórház | Nyíregyháza | 4400 | Hungary |
| Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika | Pécs | 7623 | Hungary |
| Cork University Hospital | Cork | Ireland |
| Beaumont Hospital | Dublin | 9 | Ireland |
| St Vincents University Hospital | Dublin | Dublin 4 | Ireland |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di | Bari | Apulia | 70124 | Italy |
| A. O. U. Federico II | Naples | Campania | 80131 | Italy |
| Università degli Studi della Campania Luigi Vanvitelli | Naples | Campania | 80131 | Italy |
| Università degli studi della Campania Luigi Vanvitelli | Naples | Campania | 80138 | Italy |
| Ospedale Cattinara | Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Rome | Lazio | 00133 | Italy |
| Policlinico Universitario A. Gemelli | Rome | Lazio | 00168 | Italy |
| A.O. Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Azienda Ospedaliera Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Irccs A.O.U.San Martino Ist | Genoa | Liguria | 16132 | Italy |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Fond. Istituto Neurologico C.Besta | Milan | Lombardy | 20133 | Italy |
| IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla | Pavia | Lombardy | 27100 | Italy |
| IRCCS Istituto Neurologico Neuromed | Pozzilli | Molise | 86077 | Italy |
| Azienda Sanitaria Ospedaliera S. Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| AOU Città della Salute e della Scienza | Turin | Piedmont | 10126 | Italy |
| Ospedale Binaghi | Cagliari | Sardinia | 09126 | Italy |
| AOU Policlinico V. Emanuele - P.O G. Rodolico | Catania | Sicily | 95123 | Italy |
| AOUC Azienda Ospedaliero-Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| Policlinico G.B. Rossi | Verona | Veneto | 37134 | Italy |
| American University of Beirut - Medical Center | Beirut | 11-236 | Lebanon |
| Lebanese American University Medical Center- Rizk Hospial | Beirut | Lebanon |
| Grupo Medico de Investigacion Clinica Multidisciplinaria | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Clinstile S.A de C.V. | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Hospital General de Mexico | Mexico | Tlaxcala | 06726 | Mexico |
| Unidad de investigacion en salud (UIS) | Mexico City | 14050 | Mexico |
| Centre Hospitalier Universitaire Hassan II | Fes | 30000 | Morocco |
| Hopital Cheikh Zaid | Rabat | 10000 | Morocco |
| Hopital Militaire d'Instruction Mohamed V | Rabat | 10100 | Morocco |
| Amphia Ziekenhuis | Breda | 4818 CK | Netherlands |
| Catharina ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Maasstadziekenhuis | NL -rotterdam | 3079 DZ | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Consultorios Médicos PaItilla | Panama City | Panama |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-276 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-503 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| SP Swiecickiego UM Marcinkowskiego | Późna | 60-355 | Poland |
| Centrum Medyczne "MEDYK" | Rzeszów | 35-055 | Poland |
| Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy | Warsaw | 04-141 | Poland |
| SPSK nr 1 | Zabrze | 41-800 | Poland |
| Jusupovskaya Hospital | Moscow | Moscow Oblast | 117186 | Russia |
| Vladimirskiy Regional Scientific Research Inst. | Moscow | Moscow Oblast | 129110 | Russia |
| City Clinical Hospital #24 | Moskva | Moscow Oblast | 127015 | Russia |
| National Center of Social Significant Disease | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen de Arrixaca | Murcia | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Cleveland Clinic Abu Dhabi | Abu Dhabi | 112412 | United Arab Emirates |
| Rashid hospital | Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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