ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01194570
Recruitment Status : Active, not recruiting
First Posted : September 3, 2010
Results First Posted : December 26, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 will continue their treatment with open-label ocrelizumab until the last participant who entered the OLE phase reaches 4 years of open-label ocrelizumab treatment.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Primary Progressive Drug: Ocrelizumab Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2, 2011
Actual Primary Completion Date : July 23, 2015
Estimated Study Completion Date : April 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Placebo
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.
Drug: Ocrelizumab
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.
Other: Placebo
Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Placebo Comparator: Ocrelizumab 600 mg
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.
Drug: Ocrelizumab
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.



Primary Outcome Measures :
  1. Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period [ Time Frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm ]
    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 :
  1. Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period [ Time Frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm ]
    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.

  2. Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120 [ Time Frame: Baseline, Week 120 ]
  3. Percent Change From Baseline in Total Volume of T2 Lesions at Week 120 [ Time Frame: From Baseline to Week 120 ]
  4. Percent Change in Total Brain Volume From Week 24 to Week 120 [ Time Frame: From Week 24 to Week 120 ]
  5. Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120 [ Time Frame: From Baseline to 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.

  6. Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks) ]
    AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194570


  Hide Study Locations
Locations
United States, Arizona
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States, 85006
Barrow Neurology Clinic
Phoenix, Arizona, United States, 85013
Hope Research Institute
Phoenix, Arizona, United States, 85050
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Sutter East Bay Medical Foundation
Berkeley, California, United States, 94705
MS Center of Southern California
Newport Beach, California, United States, 92663
Univ of CA Davis Med Ctr; Neurology
Sacramento, California, United States, 95817
Univ of CA San Francisco; Department of Neurology
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora, Colorado, United States, 80045
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neurology Associates, PA; Research Department
Maitland, Florida, United States, 32751
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami, Florida, United States, 33136
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
MS Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Georgia
Emory University Clinic
Atlanta, Georgia, United States, 30322
Ms Center Of Atlanta
Atlanta, Georgia, United States, 30327
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
MidAmerica Neuroscience Institute
Prairie Village, Kansas, United States, 66206
United States, Michigan
Wayne State University; Department of Neurology
Detroit, Michigan, United States, 48201
Henry Ford Health System; Neurology & Neurosurgery
Detroit, Michigan, United States, 48202
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
University of Minnesota; Clin. Neuro Research Unit
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Washington University School of Medicine; Department of Neurology
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, New Mexico
University of New Mexico; MS Specialty Clinic
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Medical College; Neurology
Albany, New York, United States, 12208
Winthrop University Hospital
Mineola, New York, United States, 11501
Weill Medical College of Cornell University; Judith Jaffe MS Ctr
New York, New York, United States, 10021
Mount Sinai School of Medicine; Neurology
New York, New York, United States, 10029
Comprehensive MS Care Center at South Shore Neurologic Assoc.
Patchogue, New York, United States, 11772
University of Rochester - Strong Memorial Hospital
Rochester, New York, United States, 14642
Neurology Assoc of Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
Cornerstone Research Care; Adv. Neuro Pain/MS/Movement Disorder Ctr
Advance, North Carolina, United States, 27006
Carolinas Medical Center; Ms Center
Charlotte, North Carolina, United States, 28207
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Health System; Clinical Research & Tech Ctr
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Trustees of the University of Pennsylvania; Neurology
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Neurology Foundation, Inc.
Providence, Rhode Island, United States, 02905
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390-8897
Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
Houston, Texas, United States, 77030
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
United States, Virginia
Neurological Associates, Inc.
Richmond, Virginia, United States, 23229
United States, Washington
Swedish Neuroscience Institute; Multiple Sclerosis Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Aurora Health Care Clinical Research
Milwaukee, Wisconsin, United States, 53215
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research
Fitzroy, Victoria, Australia, 3065
Austin Health; N-CRESS
Heidelberg, Victoria, Australia, 3084
Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck, Austria, 6020
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
Linz, Austria, 4020
Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
Linz, Austria, 4021
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
Salzburg, Austria, 5020
Landeskrankenhaus Villach
Villach, Austria, 9500
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
CHU Tivoli
La Louvière, Belgium, 7100
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
AZ Alma vzw (Sijsele)
Sijsele, Belgium, 8340
Brazil
Hospital das Clinicas - UFG; Neurociencia
Goiania, GO, Brazil, 74605-020
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte, MG, Brazil, 30150-221
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, RJ, Brazil, 22290-240
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Bulgaria
UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases
Pleven, Bulgaria, 5800
Shat Np Sveti Naum; 3Rd Clinic of Neurology
Sofia, Bulgaria, 1113
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
Sofia, Bulgaria, 1309
Tokuda Hospital; Department of Neurology
Sofia, Bulgaria, 1407
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R8A 1R9
Canada, Ontario
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael'S Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada, H3A 2B4
Czechia
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, Czechia, 625 00
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
Praha 2, Czechia, 128 08
Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice, Czechia, 415 29
Denmark
Sydjysk Skleroseklinik - Sønderborg
Sønderborg, Denmark, 6400
Finland
Helsingin yliopistollinen keskussairaala
Helsinki, Finland, 00290
Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö
Tampere, Finland, 33520
Suomen Terveystalo Clinical Research Oy
Turku, Finland, 20100
Turun yliopistollinen keskussairaala
Turku, Finland, 20520
France
Hopital Jean Minjoz
Besancon, France, 25030
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux, France, 33076
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
Bron, France, 69677
Hopital Cote De Nacre; Unite Neurologie Generale
Caen, France, 14033
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, France, 63003
Hopital Roger Salengro; Service de Neurologie
Lille, France, 59037
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, France, 13005
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
CHRU Nancy; Service de neurologie
Nancy, France, 54035
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, France, 44805
Hôpital Pasteur; Service de Neurologie
Nice, France, 06002
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
Nimes, France, 30029
Fondation Rothschild; Service de Neurologie
Paris, France, 75019
Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
Paris, France, 75651
Hôpital de Poissy; Service neurologie
Poissy, France, 78300
Hôpital Maison Blanche; Service de Neurologie
Reims, France, 51092
Chu De Strasbourg; Hopital Civil
Strasbourg, France, 67091
Hopital Purpan; Fédération de neurologie
Toulouse, France, 31059
Germany
Klinikum Bayreuth GmbH; Neurologische Klinik
Bayreuth, Germany, 95445
Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
Berg, Germany, 82335
Charité - Universitätsmedizin Berlin; Klinik für Neurologie
Berlin, Germany, 10117
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, Germany, 13347
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
Bochum, Germany, 44789
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie
Dresden, Germany, 01307
Heinrich Heine Universität Düsseldorf; Neurologische Klinik
Düsseldorf, Germany, 40225
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt am Main, Germany, 60528
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
Gießen, Germany, 35385
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Kliniken der Stadt Koln gGmbH
Koln, Germany, 51109
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
Leipzig, Germany, 04103
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35032
Klinikum rechts der Isar der TU München; Neurologische Klinik und Poliklinik
Munich, Germany, 81675
Universitätsklinikum Münster
Münster, Germany, 48149
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie
Regensburg, Germany, 93053
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, Germany, 89081
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany, 65191
Greece
401 Military Hospital of Athens; Neurology Department
Athens, Greece, 11525
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Thessaloniki, Greece, 54636
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft
Budapest, Hungary, 1033
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, Hungary, 1145
Jahn Ferenc Dél-Pesti Kórház
Budapest, Hungary, 1204
Vaszary Kolos Korhaz; Neurology
Esztergom, Hungary, 2500
Pécsi Tudományegyetem
Pécs, Hungary, 7623
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
Szeged, Hungary, 6725
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Veszprem, Hungary, 8200
Israel
Barzilai Medical Center; Neurology Department
Ashkelon, Israel, 78278
Bnai Zion Medical Center; Neurology Department
Haifa, Israel, 31048
Rabin Medical Center; Multiple Sclerosis Clinic
Petach Tikva, Israel, 49100
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan, Israel, 52621
Hadassah University Hospital Ein Kerem; Neurology Department
Safed, Israel, 13100
Medical Center Ziv Safed; Neurology Department
Safed, Israel, 13100
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, Israel, 6423906
Italy
A.O. Universitaria S. Martino Di Genova
Genova, Liguria, Italy, 16132
Hospital San Raffaele
Milano, Lombardia, Italy, 20132
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano, Piemonte, Italy, 10043
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari, Sardegna, Italy, 09126
Lithuania
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Klaipeda University Hospital; Public Institution
Klaipeda, Lithuania, 92288
Siauliai Hospital
Siauliai, Lithuania, 76231
Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, Mexico, 20127
Instituto Nacional de Neurologia y Neurocirugia
Mexico City, Mexico, 14390
Eleccion Salud SC
Mexico, Mexico, 03600
Centro de Estudios Clinicos y Espec. Med. SC
Monterrey, Mexico, 64620
Netherlands
Erasmus MC; Afdeling Neurologie
Rotterdam, Netherlands, 3015 GD
Zuyderland Medisch Centrum
Sittard-Geleen, Netherlands, 6162 BG
New Zealand
Waikato Hospital; Neurology
Hamilton, New Zealand, 3240
Wellington Hospital; Department of Neurology
Wellington, New Zealand, 6021
Norway
Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling
Oslo, Norway, 0407
Peru
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista, Peru, Callao 2
Clinica Anglo Americana
Lima, Peru, 18
Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
Lima, Peru, Lima 1
Poland
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
Bialystok, Poland, 15-402
Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
Jaroslaw, Poland, 37-500
Diagnomed Clinical Research Sp. z o.o.
Katowice, Poland, 40-594
Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic
Katowice, Poland, 40-752
Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny
Konskie, Poland, 26-200
SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii
Lodz, Poland, 90-153
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin, Poland, 20-954
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
Plewiska, Poland, 62-064
H.Swiecickiego Uni. Med. im. Karola Marcinkowskiego w Poznaniu; Neuro
Poznan, Poland, 60-355
Portugal
Hospital Garcia de Orta; Servico de Neurologia
Almada, Portugal, 2801-951
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, Portugal, 2720-276
HUC; Servico de Neurologia
Coimbra, Portugal, 3000-075
Hospital Geral; Servico de Neurologia
Coimbra, Portugal, 3041-801
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Lisboa, Portugal, 1169-050
Hospital de Santa Maria; Servico de Neurologia
Lisboa, Portugal, 1649-035
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, Portugal, 4099-001
Romania
Elias Emergency University Hospital Neurology Dept; Neurology Department
Bucharest, Romania, 011461
Dr. Carol Davila Emergency Central Military Hosp ; Neurology Department
Bucharest, Romania, 060011
SC Clubul Sanatatii SRL
Campulung, Romania, 115100
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Targu Mures, Romania, 540136
Timisoara Emergency County Clinical Hospital
Timisoara, Romania, 300736
Russian Federation
Research Medical Complex "Vashe Zdorovie"; Neurology Department
Kazan, Russian Federation, 420103
Spain
Hospital Donostia
San Sebastian, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital de Basurto; Servicio de Neurologia
Bilbao, Vizcaya, Spain, 48013
Hospital General Univ. de Alicante
Alicante, Spain, 03010
Hospital del Mar; Servicio de Neurologia
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona, Spain, 08035
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, Spain, 08036
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
Girona, Spain, 17007
Universitario de La Princesa; Servicio de Neurología
Madrid, Spain, 28006
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Neurología
Madrid, Spain, 28040
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla, Spain, 41009
Switzerland
Universitätsspital Basel; Neurologie
Basel, Switzerland, 4031
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano, Switzerland, 6903
Universitätsspital Zürich; Klinik für Neurologie
Zürich, Switzerland, 8091
Turkey
Hacettepe University Medical Faculty; Neurology
Ankara, Turkey, 06100
Trakya University Medical Faculty; Neurology
Edirne, Turkey, 22030
Kocaeli University Hospital; Department of Neurology
Kocaeli, Turkey, 41380
Ukraine
Bukovinian Medical State University; Department of Neurology
Chernivtsi, Ukraine, 58000
Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro
Dnipropetrovsk, Ukraine, 49027
Dnipropetrovsk State Medical Academy; Dept of Neurology
Dnipropetrovsk, Ukraine, 49044
Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology
Kharkiv, Ukraine, 61176
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov, Ukraine, 61068
Kyiv Regional Clinical Hospital; Neurologic Department
Kiev, Ukraine, 04107
Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology
Kyiv, Ukraine, 03110
Municipal Institution Lutsk City Clinical Hospital
Lutsk, Ukraine, 43024
Volyn Regional Clinical Hospital
Lutsk, Ukraine, 43024
Lviv Regional Clinical Hospital; Department of Neurology
Lviv, Ukraine, 79010
Odesa Regional Clinical Hospital; Neurosurgery Department
Odesa, Ukraine, 65117
Ternopil State Medical University; Dept.of neurol.psych.addictol.&med.psychol
Ternopil, Ukraine, 46027
Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3
Vinnytsya, Ukraine, 21018
United Kingdom
Walton Center For Neurology & Neurosurgery; Clinical Trials Unit
Liverpool, United Kingdom, L9 7LJ
Barts and the London NHS Trust
London, United Kingdom, E1 2ES
Kings College Hospital; Neurology
London, United Kingdom, SE5 9RS
Royal Victoria Infirmary; Neurology Dept.
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Uni Hospital Queens Medical Centre; Neurology
Nottingham, United Kingdom, NG7 2UH
Uruguay
Indiana University Medical Center; Department of Neurology
Indianapolis, Uruguay, 46202
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194570     History of Changes
Other Study ID Numbers: WA25046
2010-020338-25 ( EudraCT Number )
First Posted: September 3, 2010    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: May 25, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases