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This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocrelizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent Form
  • Able to comply with the study protocol, in the investigator's judgment
  • Completed the treatment period of Roche sponsored ocrelizumab P-trials

Exclusion Criteria:

  • Hypersensitivity to ocrelizumab or to any of its excipients.
  • Participantss in a severely immunocompromised state until the condition resolves.
  • Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
  • Existence of a contra-indication as per SmPC
  • Prohibited concomitant medication as specified in protocol
  • Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

Sites / Locations

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • Hospital Churruca Visca
  • Fundacion Rosarina de Neurorehabilitacion
  • AZ Sint Jan
  • UZ Antwerpen
  • CHU Tivoli
  • CHU Sart-Tilman
  • Revalidatie en MS Centrum
  • Instituto de Neurologia de Curitiba
  • Hospital Sao Lucas - PUCRS
  • Hospital das Clinicas - FMUSP
  • Shat Np Sveti Naum; 3Rd Clinic of Neurology
  • Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
  • University of British Columbia
  • London Health Sciences Centre Uni Campus
  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
  • Sunnybrook Health Sciences Centre
  • Clinique NeuroOutaouais
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital
  • Clinical Hospital Centre Zagreb
  • Fakultni nemocnice u sv. Anny; Neurologicka klinika
  • Nemocnice Jihlava; NEU-Neurologicke oddeleni
  • VFN Praha Poliklinika Rs Centrum - Budova A
  • Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol
  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
  • Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Rigshospitalet Glostrup; Neurologisk Klinik
  • Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken
  • East Tallinn Central Hospital; Neurology Department
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • Mehiläinen Neo Turku
  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B
  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • CH de Gonesse; Neurologie
  • CHU de Grenoble; Neurologie
  • Hopital Roger Salengro Service de Neurologie
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hopital Central - CHU de Nancy; Service de Neurologie
  • Hôpital Guillaume et René Laënnec; Service Neurologie
  • Hôpital Pasteur; Service de Neurologie
  • CHU de Nîmes Hopital Caremeau; Service de Neurologie
  • Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
  • Hôpital de Poissy; Service neurologie
  • CHU de Rouen Hopital; Service de Neurologie
  • Höpital Hautepierre; Pediatrie1
  • HIA de Toulon hôpital militaire; Neurologie
  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
  • VALEOMED Diagnosztikai Központ
  • St Vincents University Hospital
  • Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
  • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
  • Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
  • Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
  • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
  • Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla
  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
  • Ospedale Binaghi; Centro Sclerosi Multipla
  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
  • Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
  • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
  • AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
  • AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
  • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
  • AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
  • Azienda Ospedaliera di Padova; Clinica Neurologica
  • Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
  • Ibn Sina Hospital; Neurology Department
  • Hospital General de México
  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
  • Unidad de investigacion en salud (UIS); Neurociencias
  • Jeroen Bosch Ziekenhuis
  • Amsterdam UMC Location VUMC
  • Amphia Ziekenhuis
  • Groene Hart Ziekenhuis
  • Maasstadziekenhuis
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Elisabeth-TweeSteden Ziekenhuis
  • Haukeland universitetssykehus; Nevrologisk avdeling
  • Sykehuset Buskerud HF; Nevrologisk avdeling
  • Stavanger Universitetssykehus, Helse Stavanger HF
  • Neurocentrum Bydgoszcz sp. z o.o
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • Care Clinic
  • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
  • Centrum Neurologii Krzysztof Selmaj
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Hospital de Braga; Servico de Neurologia
  • HUC; Servico de Neurologia
  • Hospital Beatriz Angelo; Servico de Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Univerzitna nemocnica Bratislava
  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov
  • Fakultna nemocnica Trnava
  • University Medical Centre; Neurology
  • University Medical Centre Maribor
  • Hospital Universitario Central de Asturias; Servicio de Neurología
  • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Hospital General de Castellon; Servicio de Neurología
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Puerta del Mar; Sevicio de Neurologia
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Universitario La Paz; Servicio de Neurologia
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Sahlgrenska Sjukhuset; Neurology
  • Centralsjukhuset; Neurologi och rehabiliteringskliniken
  • Centrum för Neurologi
  • Karolinska Universitetssjukhuset Solna Neurology
  • Hacettepe University Medical Faculty; Neurology
  • Gazi University Medical Faculty; Departmant of Norology
  • Mustafa Kemal Ataturk UTF; Department of norology
  • Istanbul University Istanbul School of Medicine; Neurology
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Selcuk University Medical Faculty; Norology department
  • Ondokuz Mayis University School of Medicine; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • Royal Devon and Exeter Hospital (Wonford)
  • Queen Elizabeth University Hospital
  • Raigmore Hospital
  • Leeds Teaching Hospitals NHS Trust
  • The Royal London Hospital
  • Royal Free Hospital
  • St George's Hospital
  • Kings College Hospital
  • Charing Cross Hospital
  • National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
  • Royal Victoria Infirmary
  • Salford Royal NHS Foundation Trust
  • Royal Hallamshire Hospita
  • Morriston Hospital
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocrelizumab

Arm Description

Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.

Outcomes

Primary Outcome Measures

Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment
Percentage of participants who have improved, stable or worsened disability compared with baseline
Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is > 0.5 increase of EDSS, Improvement is >0.5 decrease of EDSS
Mean change from inclusion in parent study in EDSS score over the course of the treatment
Time to 20% increase in timed 25-foot walk test (T25FWT)
Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment

Secondary Outcome Measures

Time to first protocol-defined event of disease activity
Time to first relapse
Annualized relapse rate
Percentage of participants relapse free, yearly and over the course of the treatment
Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment
Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI).
Percentage 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 (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment
Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)
NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
Change in total T1 hypointense lesion volume over time
Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time
Change in brain volume (grey and white matter) as detected by brain MRI over time
Presence and evolution of leptomeningeal follicles as detected by MRI
Time to treatment discontinuation/switch
Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
Participant reported outcomes: SymptoMScreen Score
Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)
Percentage of Participants with Adverse Events
Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period

Full Information

First Posted
June 25, 2018
Last Updated
September 28, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03599245
Brief Title
This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Official Title
A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
February 23, 2025 (Anticipated)
Study Completion Date
March 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).
Detailed Description
This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
Primary Outcome Measure Information:
Title
Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
Time Frame
Up to 2 Years
Title
Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment
Time Frame
Up to 2 years
Title
Percentage of participants who have improved, stable or worsened disability compared with baseline
Description
Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is > 0.5 increase of EDSS, Improvement is >0.5 decrease of EDSS
Time Frame
Up to 2 years
Title
Mean change from inclusion in parent study in EDSS score over the course of the treatment
Time Frame
Up to 2 years
Title
Time to 20% increase in timed 25-foot walk test (T25FWT)
Description
Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Time to first protocol-defined event of disease activity
Time Frame
Up to 2 Years
Title
Time to first relapse
Time Frame
Up to 2 Years
Title
Annualized relapse rate
Time Frame
Up to 2 Years
Title
Percentage of participants relapse free, yearly and over the course of the treatment
Time Frame
Up to 2 Years
Title
Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment
Description
Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI).
Time Frame
Up to 2 Years
Title
Percentage of participants with no evidence of progression (NEP)
Description
NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment
Time Frame
Up to 2 Years
Title
Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)
Description
NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment
Time Frame
Up to 2 Years
Title
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
Time Frame
Up to 2 Years
Title
Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
Time Frame
Up to 2 Years
Title
Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
Time Frame
Up to 2 Years
Title
Change in total T1 hypointense lesion volume over time
Time Frame
Up to 2 Years
Title
Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time
Time Frame
Up to 2 Years
Title
Change in brain volume (grey and white matter) as detected by brain MRI over time
Time Frame
Up to 2 Years
Title
Presence and evolution of leptomeningeal follicles as detected by MRI
Time Frame
Up to 2 Years
Title
Time to treatment discontinuation/switch
Time Frame
Up to 2 Years
Title
Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
Time Frame
Up to 2 Years
Title
Participant reported outcomes: SymptoMScreen Score
Time Frame
Up to 2 Years
Title
Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)
Time Frame
Up to 2 Years
Title
Percentage of Participants with Adverse Events
Time Frame
Up to 2 Years
Title
Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form Able to comply with the study protocol, in the investigator's judgment Completed the treatment period of Roche sponsored ocrelizumab P-trials Exclusion Criteria: Hypersensitivity to ocrelizumab or to any of its excipients. Participantss in a severely immunocompromised state until the condition resolves. Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation. Existence of a contra-indication as per SmPC Prohibited concomitant medication as specified in protocol Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Facility Name
Hospital Churruca Visca
City
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
ZIP/Postal Code
S2000BZL
Country
Argentina
Facility Name
AZ Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Revalidatie en MS Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Shat Np Sveti Naum; 3Rd Clinic of Neurology
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
London Health Sciences Centre Uni Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Clinique NeuroOutaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice u sv. Anny; Neurologicka klinika
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Jihlava; NEU-Neurologicke oddeleni
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
VFN Praha Poliklinika Rs Centrum - Budova A
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Facility Name
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet Glostrup; Neurologisk Klinik
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
East Tallinn Central Hospital; Neurology Department
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Mehiläinen Neo Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH de Gonesse; Neurologie
City
Gonesse
ZIP/Postal Code
95503
Country
France
Facility Name
CHU de Grenoble; Neurologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Roger Salengro Service de Neurologie
City
Lille
Country
France
Facility Name
CHU de la Timone - Hopital d Adultes; Service de Neurologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Central - CHU de Nancy; Service de Neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hôpital Guillaume et René Laënnec; Service Neurologie
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Pasteur; Service de Neurologie
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
CHU de Nîmes Hopital Caremeau; Service de Neurologie
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital de Poissy; Service neurologie
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
CHU de Rouen Hopital; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Höpital Hautepierre; Pediatrie1
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
HIA de Toulon hôpital militaire; Neurologie
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
VALEOMED Diagnosztikai Központ
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
St Vincents University Hospital
City
Dublin 4
Country
Ireland
Facility Name
Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy
Facility Name
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
City
Gallarate
State/Province
Lombardia
ZIP/Postal Code
21013
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
Country
Italy
Facility Name
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
City
Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy
Facility Name
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Binaghi; Centro Sclerosi Multipla
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Facility Name
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
City
Cefalù
State/Province
Sicilia
ZIP/Postal Code
90015
Country
Italy
Facility Name
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
Country
Italy
Facility Name
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Clinica Neurologica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Ibn Sina Hospital; Neurology Department
City
Kuwait
ZIP/Postal Code
10002
Country
Kuwait
Facility Name
Hospital General de México
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Unidad de investigacion en salud (UIS); Neurociencias
City
Ciudad de México
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Jeroen Bosch Ziekenhuis
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Amsterdam UMC Location VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Maasstadziekenhuis
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Haukeland universitetssykehus; Nevrologisk avdeling
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Buskerud HF; Nevrologisk avdeling
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Stavanger Universitetssykehus, Helse Stavanger HF
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Care Clinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Facility Name
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Hospital de Braga; Servico de Neurologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Beatriz Angelo; Servico de Neurologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
University Medical Centre; Neurology
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
University Medical Centre Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Hospital Universitario Central de Asturias; Servicio de Neurología
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General de Castellon; Servicio de Neurología
City
Castelló de la Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
City
Salt
State/Province
Girona
ZIP/Postal Code
17190
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
City
Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
City
Lleida
State/Province
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
EL Palmar (EL Palmar)
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Puerta del Mar; Sevicio de Neurologia
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Sjukhuset; Neurology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Centralsjukhuset; Neurologi och rehabiliteringskliniken
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Centrum för Neurologi
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna Neurology
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty; Departmant of Norology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Mustafa Kemal Ataturk UTF; Department of norology
City
Hatay
ZIP/Postal Code
31001
Country
Turkey
Facility Name
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Selcuk University Medical Faculty; Norology department
City
Istanbul
ZIP/Postal Code
42131
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UV
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7AU
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
City
London
ZIP/Postal Code
WC1 3BG
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Royal Hallamshire Hospita
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

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