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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Primary Progressive

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

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Primary Progressive

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
  • EDSS at screening from 3 to 6.5 points
  • Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0
  • Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

Exclusion Criteria:

  • History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening
  • Inability to complete an MRI (contraindications for MRI)
  • Known presence of other neurologic disorders
  • Known active infection or history of or presence of recurrent or chronic infection
  • History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
  • Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

Sites / Locations

  • Phoenix Neurological Associates Ltd
  • Barrow Neurology Clinic
  • Mayo Clinic- Scottsdale
  • Arizona Neuroscience Research LLC
  • Sutter East Bay Medical Foundation
  • MS Center of Southern California
  • Univ of CA Davis Med Ctr; Neurology
  • Univ of CA San Francisco; Department of Neurology
  • University of Colorado; Anschutz Medical Campus Department of Neurology
  • University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
  • Vero Beach Neurology and Research Institute
  • University of Kansas Medical Center
  • MidAmerica Neuroscience Institute
  • Wayne State University; Department of Neurology
  • Henry Ford Health System; Neurology & Neurosurgery
  • Michigan Institute for Neurological Disorders
  • University of Minnesota; Clin. Neuro Research Unit
  • Washington University School of Medicine; Department of Neurology
  • Holy Name Hospital
  • University of New Mexico; MS Specialty Clinic
  • Winthrop University Hospital
  • Weill Medical College of Cornell University; Judith Jaffe MS Ctr
  • Mount Sinai School of Medicine; Neurology
  • Comprehensive MS Care Center at South Shore Neurologic Assoc.
  • Neurology Assoc of Stony Brook
  • Carolinas Medical Center; Ms Center
  • Raleigh Neurology Associates
  • The Ohio State University Wexner Medical Center; Department of Neurology
  • Oklahoma Medical Research Foundation; MS Center of Excellence
  • Trustees of the University of Pennsylvania; Neurology
  • The Neurology Foundation, Inc.
  • Neurology Clinic PC
  • University of Texas Southwestern
  • Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
  • Neurological Associates, Inc.
  • Swedish Neuroscience Institute; Multiple Sclerosis Center
  • Royal Hobart Hospital
  • St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research
  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
  • Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
  • Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
  • Medizinische Universitat Wien Medical University of Vienna
  • CHU Tivoli
  • AZ Alma vzw (Sijsele)
  • Hospital das Clinicas - UFG;Reumatologia
  • Santa Casa de Misericordia; de Belo Horizonte
  • Hospital Universitario Clementino Fraga Filho - UFRJ
  • Hospital Sao Lucas - PUCRS
  • Shat Np Sveti Naum; 3Rd Clinic of Neurology
  • Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
  • Foothills Medical Centre
  • University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver
  • Health Sciences Centre
  • The Ottawa Hospital - General Campus
  • St. Michael'S Hospital
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital
  • Fakultni nemocnice Brno; Interni kardiologicka klinika
  • Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
  • Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
  • Helsingin yliopistollinen keskussairaala
  • Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö
  • Turku University Central Hospital; Pharmacy
  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B
  • Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
  • Hopital Cote De Nacre; Unite Neurologie Generale
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • Hopital Roger Salengro Service de Neurologie
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • CHRU Nancy; Service de neurologie
  • Hôpital Guillaume et René Laënnec; Service Neurologie
  • Hôpital Pasteur; Service de Neurologie
  • Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
  • Fondation Rothschild; Service de Neurologie
  • Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
  • Hôpital de Poissy; Service neurologie
  • Hôpital Maison Blanche; Service de Neurologie
  • Chu De Strasbourg; Hopital Civil
  • Hopital Purpan; Fédération de neurologie
  • Klinikum Bayreuth GmbH; Neurologische Klinik
  • Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
  • Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie
  • Heinrich Heine Universität Düsseldorf; Neurologische Klinik
  • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
  • Universitätsklinikum Gießen und Marburg GmbH; Neurologie
  • Universitaetsklinikum Heidelberg
  • Kliniken der Stadt Koln gGmbH
  • Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
  • Klinikum rechts der Isar der Technischen Universität München
  • Universitatsklinikum Munster
  • Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)
  • 401 Military Hospital of Athens; Neurology Department
  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
  • Georgios Papanikolaou General Hosp. of Thessaloniki
  • Fövárosi Önkormányzat uzsoki utcai Kórház
  • Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
  • Vaszary Kolos Korhaz; Neurology
  • Pécsi Tudományegyetem
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
  • Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
  • Barzilai Medical Center; Neurology Department
  • Hadassah University Hospital Ein Kerem; Neurology Department
  • Rabin Medical Center; Multiple Sclerosis Clinic
  • The Chaim Sheba Medical Center; Multiple Sclerosis Center
  • Medical Center Ziv Safed; Neurology Department
  • Tel Aviv Sourasky Medical Center; Department of Neurology
  • A.O. Universitaria S. Martino Di Genova
  • Hospital San Raffaele
  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
  • Ospedale Binaghi; Centro Sclerosi Multipla
  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Klaipeda University Hospital Public Institution
  • Siauliai Hospital
  • Instituto Nacional de Neurologia y Neurocirugia
  • Eleccion Salud SC
  • Centro de Estudios Clinicos y Espec. Med. SC
  • Instituto Biomedico De Investigacion A.C.
  • Erasmus MC; Afdeling Neurologie
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Waikato Hospital; Neurology
  • Wellington Hospital; Department of Neurology
  • Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling
  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Clinica Anglo Americana
  • Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
  • Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
  • Diagnomed Clinical Research Sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic
  • Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny
  • SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
  • Hospital Garcia de Orta; Servico de Neurologia
  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
  • HUC; Servico de Neurologia
  • Hospital Geral; Servico de Neurologia
  • Hospital de Santa Maria; Servico de Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Elias Emergency University Hospital Neurology Dept; Neurology Department
  • SC Clubul Sanatatii SRL
  • Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
  • Timisoara Emergency County Clinical Hospital
  • Research Medical Complex "Vashe Zdorovie"; Neurology Department
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
  • Hospital Donostia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas
  • Hospital de Basurto Servicio de Neurologia
  • Hospital General Univ. de Alicante
  • Hospital del Mar; Servicio de Neurologia
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Hospital Clinic i Provincial; Servicio de Neurologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Universitätsspital Basel; Neurologie
  • Ospedale Regionale di Lugano - Civico; Neurologia
  • CNPE City Clinical Hospital #3 of Chernivtsi City Council
  • Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro
  • Dnipropetrovsk State Medical Academy; Dept of Neurology
  • Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology
  • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
  • Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology
  • Volyn Regional Clinical Hospital
  • Lviv Regional Clinical Hospital; Department of Neurology
  • Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3
  • Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
  • Barts and the London NHS Trust
  • Kings College Hospital; Neurology
  • Royal Victoria Infirmary; Neurology Dept.
  • Uni Hospital Queens Medical Centre; Neurology
  • Indiana University Medical Center; Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Placebo

Ocrelizumab 600 mg

Arm Description

Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.

Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Outcomes

Primary Outcome Measures

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.

Secondary Outcome Measures

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Percent Change From Baseline in Total Volume of T2 Lesions at Week 120
Percent Change in Total Brain Volume From Week 24 to Week 120
Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120
The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Percentage of Participants With at Least One Adverse Event (AE)
AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.

Full Information

First Posted
August 28, 2010
Last Updated
May 19, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01194570
Brief Title
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Official Title
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2011 (Actual)
Primary Completion Date
July 23, 2015 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
735 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Arm Title
Ocrelizumab 600 mg
Arm Type
Placebo Comparator
Arm Description
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Primary Outcome Measure Information:
Title
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period
Description
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time Frame
Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Secondary Outcome Measure Information:
Title
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period
Description
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time Frame
Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Title
Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Time Frame
Baseline, Week 120
Title
Percent Change From Baseline in Total Volume of T2 Lesions at Week 120
Time Frame
From Baseline to Week 120
Title
Percent Change in Total Brain Volume From Week 24 to Week 120
Time Frame
From Week 24 to Week 120
Title
Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120
Description
The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
From Baseline to Week 120
Title
Percentage of Participants With at Least One Adverse Event (AE)
Description
AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.
Time Frame
From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria) EDSS at screening from 3 to 6.5 points Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0 Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose Exclusion Criteria: History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening Inability to complete an MRI (contraindications for MRI) Known presence of other neurologic disorders Known active infection or history of or presence of recurrent or chronic infection History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved) Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the 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
Phoenix Neurological Associates Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurology Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic- Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Neuroscience Research LLC
City
Phoenix
State/Province
Arkansas
ZIP/Postal Code
85032-2181
Country
United States
Facility Name
Sutter East Bay Medical Foundation
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
MS Center of Southern California
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Univ of CA Davis Med Ctr; Neurology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Univ of CA San Francisco; Department of Neurology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado; Anschutz Medical Campus Department of Neurology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Vero Beach Neurology and Research Institute
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Wayne State University; Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System; Neurology & Neurosurgery
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan Institute for Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
University of Minnesota; Clin. Neuro Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Washington University School of Medicine; Department of Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
University of New Mexico; MS Specialty Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Weill Medical College of Cornell University; Judith Jaffe MS Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine; Neurology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Comprehensive MS Care Center at South Shore Neurologic Assoc.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Neurology Assoc of Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolinas Medical Center; Ms Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
The Ohio State University Wexner Medical Center; Department of Neurology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Oklahoma Medical Research Foundation; MS Center of Excellence
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Trustees of the University of Pennsylvania; Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Neurology Foundation, Inc.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8897
Country
United States
Facility Name
Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurological Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Swedish Neuroscience Institute; Multiple Sclerosis Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universitat Wien Medical University of Vienna
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
AZ Alma vzw (Sijsele)
City
Sijsele
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Hospital das Clinicas - UFG;Reumatologia
City
Goiania
State/Province
GO
ZIP/Postal Code
74653-050
Country
Brazil
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho - UFRJ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
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
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R8A 1R9
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
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
Fakultni nemocnice Brno; Interni kardiologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Helsingin yliopistollinen keskussairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Central Hospital; Pharmacy
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Cote De Nacre; Unite Neurologie Generale
City
Caen
ZIP/Postal Code
14033
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
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
CHRU 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
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Fondation Rothschild; Service de Neurologie
City
Paris
ZIP/Postal Code
75019
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
Hôpital Maison Blanche; Service de Neurologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Chu De Strasbourg; Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Purpan; Fédération de neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinikum Bayreuth GmbH; Neurologische Klinik
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
City
Berg
ZIP/Postal Code
82335
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich Heine Universität Düsseldorf; Neurologische Klinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Kliniken der Stadt Koln gGmbH
City
Koln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
401 Military Hospital of Athens; Neurology Department
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Georgios Papanikolaou General Hosp. of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Fövárosi Önkormányzat uzsoki utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Vaszary Kolos Korhaz; Neurology
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Barzilai Medical Center; Neurology Department
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem; Neurology Department
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center; Multiple Sclerosis Clinic
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center; Multiple Sclerosis Center
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Medical Center Ziv Safed; Neurology Department
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Department of Neurology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Hospital San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale Binaghi; Centro Sclerosi Multipla
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Facility Name
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital Public Institution
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Siauliai Hospital
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Instituto Nacional de Neurologia y Neurocirugia
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14390
Country
Mexico
Facility Name
Eleccion Salud SC
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
3600
Country
Mexico
Facility Name
Centro de Estudios Clinicos y Espec. Med. SC
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Instituto Biomedico De Investigacion A.C.
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Erasmus MC; Afdeling Neurologie
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Waikato Hospital; Neurology
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Hospital; Department of Neurology
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
City
Jaroslaw
ZIP/Postal Code
37-500
Country
Poland
Facility Name
Diagnomed Clinical Research Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic
City
Katowice
ZIP/Postal Code
40-686
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Hospital Garcia de Orta; Servico de Neurologia
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Geral; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Elias Emergency University Hospital Neurology Dept; Neurology Department
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
SC Clubul Sanatatii SRL
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Timisoara Emergency County Clinical Hospital
City
Timi?oara
ZIP/Postal Code
300595
Country
Romania
Facility Name
Research Medical Complex "Vashe Zdorovie"; Neurology Department
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420103
Country
Russian Federation
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
Hospital Donostia
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de Basurto Servicio de Neurologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital General Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Universitätsspital Basel; Neurologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano - Civico; Neurologia
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
CNPE City Clinical Hospital #3 of Chernivtsi City Council
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
City
Odesa
State/Province
Kherson Governorate
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Dnipropetrovsk State Medical Academy; Dept of Neurology
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital; Department of Neurology
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Kings College Hospital; Neurology
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Victoria Infirmary; Neurology Dept.
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Uni Hospital Queens Medical Centre; Neurology
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Indiana University Medical Center; Department of Neurology
City
Indianapolis
ZIP/Postal Code
46202
Country
Uruguay

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

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