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This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the overall SymptoMScreen score in participants with RMS | SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities) | 4 years |
| Changes in the overall SymptoMScreen score in participants with PPMS | SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of RMS Participants with Adverse Events | 4 years | |
| Percentage of PPMS participants with Adverse Events | 4 years | |
| Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with RMS or PPMS undergoing routine clinical care
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Amstetten | Amstetten | 3300 | Austria | |||
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck |
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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| 4 years |
| Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS | 4 years |
| Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants | 4 years |
| Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants | 4 years |
| Change in the score of ABILHAND - 56 scale in RMS participants | 4 years |
| Change in the score of ABILHAND - 56 scale in PPMS participants | 4 years |
| Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant | 4 years |
| Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants | 4 years |
| Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants | 4 years |
| Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants | 4 years |
| Change in the score of MSWS - 12 scale in RMS participants | 4 years |
| Change in the score of MSWS - 12 scale in PPMS participants | 4 years |
| Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants | 4 years |
| Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants | 4 years |
| Frequency of relapses over time in RMS patients | 4 years |
| Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time | 4 years |
| Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time | 4 years |
| Innsbruck |
| 6020 |
| Austria |
| Kepler Universitätsklinikum GmbH - Neuromed Campus | Linz | 4020 | Austria |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | 4021 | Austria |
| Multiple Sklerose Zentrum | Melk | 3390 | Austria |
| Klinik Floridsdorf | Vienna | 1210 | Austria |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| AZ KLINA | Brasschaat | 2930 | Belgium |
| Hospital Erasme | Brussels | 1070 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| CHU de Charleroi | Charleroi | 6042 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| CNRF - Centre Neurologique et Réadaptation Fonctionnelle | Fraiture | 4557 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| CHC MontLégia | Liège | 4000 | Belgium |
| Nationaal MS Centrum | Melsbroek | 1820 | Belgium |
| CHU UCL Mont-Godinne | Mont-godinne | 5530 | Belgium |
| AZ Oostende | Ostend | 8400 | Belgium |
| Revalidatie en MS Centrum | Overpelt | 3900 | Belgium |
| AZ Delta (Campus Rumbeke) | Roeselare | 8800 | Belgium |
| Clinica Amo Assistencia Medica Em Oncologia | Salvador | Estado de Bahia | 41950-610 | Brazil |
| Hospital de Base do Distrito Federal | Brasília | Federal District | 70330-150 | Brazil |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| CPQuali Pesquisa Clinica Ltda | São Paulo | São Paulo | 01228-000 | Brazil |
| Hospital Universitario Gaffree e Guinle | Rio de Janeiro | 20270-004 | Brazil |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | 5800 | Bulgaria |
| UMHAT Sveti Georgi Clinic of neurology | Plovdiv | 4000 | Bulgaria |
| Shat Np Sveti Naum | Sofia | 1113 | Bulgaria |
| First MHAT | Sofia | 1142 | Bulgaria |
| Multiprofile Hosp. for Active Treatment | Sofia | 1309 | Bulgaria |
| "City Clinic UMHAC" EOOD | Sofia | 1407 | Bulgaria |
| Acibadem City Clinic Tokuda Hospital Ead | Sofia | 1407 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | 1431 | Bulgaria |
| UMHAT Alexandrovska, EAD | Sofia | 1431 | Bulgaria |
| UMHAT Tsaritsa Yoanna - ISUL EAD | Sofia | 1527 | Bulgaria |
| MBAL St. Marina | Varna | 9010 | Bulgaria |
| Clinica Las Condes | Santiago | 7591046 | Chile |
| Fundacion ABOOD Shaio | Bogota, DC | DUMMY_VALUE | Colombia |
| Centro Javeriano de Oncología | Bogotá | DUMMY_VALUE | Colombia |
| Organizacion Sanitas Internacional | Bogotá | DUMMY_VALUE | Colombia |
| Fundacion Clinica Valle del Lili | Cali | DUMMY_VALUE | Colombia |
| Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART) | Santo Domingo | DUMMY_VALUE | Dominican Republic |
| Faculty of Medicine-Ain Shams University | Cairo | 11566 | Egypt |
| Al Qahira Al Fatmiya Hospital | Cairo | DUMMY_VALUE | Egypt |
| Clinical Research Center-Alex university | Cairo | DUMMY_VALUE | Egypt |
| Ospedale San Salvatore | L’Aquila | Abruzzo | 67100 | Italy |
| Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari | Bari | Apulia | 70124 | Italy |
| Ospedale F. Ferrari | Casarano | Apulia | 73042 | Italy |
| Università degli Studi della Campania Luigi Vanvitelli | Naples | Campania | 80131 | Italy |
| AOU Seconda Università degli Studi | Naples | Campania | 80138 | Italy |
| Arcispedale Sant'Anna | Cona | Emilia-Romagna | 44124 | Italy |
| A.O.U. di Parma | Parma | Emilia-Romagna | 43126 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Irccs A.O.U.San Martino Ist | Genoa | Liguria | 16132 | Italy |
| Presidio Ospedaliero S.O.P.A. Micone | Sestri Ponente (GE) | Liguria | 16153 | Italy |
| Ospedale S.Antonio Abate | Gallarate | Lombardy | 21013 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | 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 |
| Policlinico San Donato | San Donato Milanese | Lombardy | 20097 | Italy |
| IRCCS Istituto Neurologico Neuromed | Pozzilli | Molise | 86077 | Italy |
| Ospedale Regina Montis Regalis | Mondovì (CN) | Piedmont | 12084 | Italy |
| Ospedale Binaghi | Cagliari | Sardinia | 09126 | Italy |
| AOU Policlinico V. Emanuele - P.O G. Rodolico | Catania | Sicily | 95123 | Italy |
| AOU Policlinico Giaccone | Palermo | Sicily | 90129 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona | Torrette - Ancona | The Marches | 60100 | Italy |
| AOU Senese - Presidio Ospedaliero Le Scotte | Siena | Tuscany | 53100 | Italy |
| Ibn Sina Hospital | Kuwait City | 10002 | Kuwait |
| Clinical Center of Montenegro | Podgorica | 20000 | Montenegro |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3430 EM | Netherlands |
| Maasstadziekenhuis | NL -rotterdam | 3079 DZ | Netherlands |
| Ziekenhuis VieCuri Medisch Centrum | Venlo | 5912 BL | Netherlands |
| Isala | Zwolle | 8025 AB | Netherlands |
| Hospital Central del Instituto de Previsión Social | Asunción | DUMMY_VALUE | Paraguay |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-276 | Poland |
| COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika | Gdansk | 80-803 | Poland |
| Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa | Głogów Małopolski | 36-060 | Poland |
| Gornoslaskie Centrum Medyczne | Katowice | 40-635 | Poland |
| UCK im. prof. K. Gibinskiego SUM | Katowice | 40-752 | Poland |
| SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM | Lodz | 90-153 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 | Rybnik | 44-200 | Poland |
| Instytut Psychiatrii i Neurologii | Warsaw | 02-957 | Poland |
| Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy | Warsaw | 04-141 | Poland |
| SPSK nr 1 | Zabrze | 41-800 | Poland |
| Hospital Santo Antonio dos Capuchos | Lisbon | 1169-050 | Portugal |
| Centro Hospitalar do Porto | Porto | 4000-436 | Portugal |
| Hamad General Hospital | Doha | 3050 | Qatar |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 11172 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Cluj-Napoca | 400012 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | 550166 | Romania |
| Spitalul Clinic Judetean de Urgenta Mures | Târgu Mureş | 540136 | Romania |
| Jusupovskaya Hospital | Moscow | Moscow Oblast | 117186 | Russia |
| National Center of Social Significant Disease | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| Regional clinical hospital named after prof. S.V. Ochapovsky | Krasnodar | 350086 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| King Abdul Aziz Medical City, King Fahd National Guard | Riyadh | 22490 | Saudi Arabia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Univerzitna Nemocnica - Nemocnica svateho Michala | Bratislava | 811 08 | Slovakia |
| Univerzitna nemocnica Bratislava - Nemocnica Ruzinov | Bratislava | 826 06 | Slovakia |
| Nemocnica akademika Ladislava Derera | Bratislava | 833 05 | Slovakia |
| Univerzitna nemocnica Martin | Martin | 036 59 | Slovakia |
| Ustredna vojenska nemocnica SNP Ruzomberok | Ružomberok | DUMMY_VALUE | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 917 75 | Slovakia |
| Hospital Universitario de Araba | Vitoria-Gasteiz | Alava | 1009 | Spain |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Corporació Sanitaria Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Figueres | Figueres | Girona | 17600 | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | LA Coruna | 15006 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital General Universitario Santa Lucia | Cartagena (Murcia) | Murcia | 30202 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Pontevedra | DUMMY_VALUE | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | DUMMY_VALUE | Spain |
| Hospital Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Tenerife | DUMMY_VALUE | Spain |
| Hospital Nuestra Señora de Sonsoles | Ávila | 05071 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14011 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Arrixaca | Murcia | DUMMY_VALUE | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Istanbul University Istanbul School of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Kocaeli University Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Mersin | 33079 | Turkey (Türkiye) |
| Ondokuz Mayis Univ. Med. Fac. | Samsun | 55139 | Turkey (Türkiye) |
| Karadeniz Tecnical Uni. Med. Fac. | Trabzon | 61080 | Turkey (Türkiye) |
| Mediclinic Parkview Hospital | Dubai-UAE | DUMMY_VALUE | United Arab Emirates |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Raigmore Hospital | Inverness | IV2 3JH | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| Lincoln County Hospital | Lincoln | LN2 5QY | United Kingdom |
| St George?s Hospital | London | SW17 ORE | United Kingdom |
| Luton General Hospital | Luton | LU4 0DZ | United Kingdom |
| James Cook Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Sunderland Royal Hospital | Sunderland | SR4 7TP | United Kingdom |
| Morriston Hospital | Swansea | SA6 6NL | United Kingdom |
| Southmead Hospital | Westbury-on-Trym, Bristol | BS10 5NB | United Kingdom |
| 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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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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