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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412333
First Posted: August 9, 2011
Last Update Posted: July 18, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

Condition Intervention Phase
Relapsing Multiple Sclerosis Drug: Interferon beta-1a Drug: Ocrelizumab-matching placebo Drug: Ocrelizumab Drug: Interferon beta-1a-matching placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks [ Time Frame: Week 96 ]
    ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.


Secondary Outcome Measures:
  • Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period [ Time Frame: Week 104 ]
    Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

  • Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment [ Time Frame: Baseline up to week 96 ]
    The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.

  • Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment [ Time Frame: Baseline up to week 96 ]
    The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.

  • Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks [ Time Frame: Week 96 ]
    Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.

  • Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period [ Time Frame: Week 104 ]
    Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

  • Number of T1 Hypointense Lesions During the Double-Blind Treatment [ Time Frame: Baseline up to week 96 ]
    The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.

  • Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96 [ Time Frame: Baseline, Week 96 ]
    MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.

  • Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96 [ Time Frame: From week 24 up to week 96 ]
    Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).

  • Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
    The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

  • Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96 [ Time Frame: Week 96 ]
    NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 96 ]
    AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.

  • Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC) [ Time Frame: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96 ]
    AUC represents total drug exposure for one dosing interval after the 4th dose.

  • Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab [ Time Frame: Baseline up to Week 96 ]
    Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.


Enrollment: 835
Actual Study Start Date: September 20, 2011
Estimated Study Completion Date: January 16, 2020
Primary Completion Date: May 12, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interferon beta-1a 44 mcg SC
Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Drug: Interferon beta-1a
Other Name: Rebif
Drug: Ocrelizumab-matching placebo
Experimental: Ocrelizumab
Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Drug: Ocrelizumab
Other Name: RO4964913
Drug: Interferon beta-1a-matching placebo

  Eligibility

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 multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS score less than or equal to (</=) 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or IV corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use
  Contacts and Locations
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): NCT01412333


  Hide Study Locations
Locations
United States, Arizona
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States, 85006
Hope Research Institute
Phoenix, Arizona, United States, 85050
ANI Research PC
Sun City, Arizona, United States, 85351
Territory Neurology and Research Institute
Tucson, Arizona, United States, 85704
United States, California
Univ of CA San Francisco; Department of Neurology
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
Collaborative Neuroscience Network Inc.
Torrance, California, United States, 90502
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
Advanced Neurosciences Research LLC
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Multiple Sclerosis Treatment Center
Derby, Connecticut, United States, 06418
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, United States, 06824
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Infinity Clinical Research
Hollywood, Florida, United States, 33021
Neurology Associates PA
Maitland, Florida, United States, 32751
University of Miami
Miami, Florida, United States, 33136
Neurological Services of Orlando
Orlando, Florida, United States, 32806
Lovelace Scientific Resources
Sarasota, Florida, United States, 34292
University of South Florida
Tampa, Florida, United States, 33613-4706
United States, Georgia
Ms Center Of Atlanta
Atlanta, Georgia, United States, 30327
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, United States, 46256
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Kentucky
Associates in Neurology PSC
Lexington, Kentucky, United States, 40513
Community Medical Associates Inc.
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-0666
Wayne State University; Department of Neurology
Detroit, Michigan, United States, 48201
United States, Minnesota
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
United States, New Jersey
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
MS Comprehensive Care Center
Teaneck, New Jersey, United States, 07666
Shore Neurology
Toms River, New Jersey, United States, 08755
United States, New York
Empire Neurology, PC
Latham, New York, United States, 12210
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
New York, New York, United States, 10065
South Shore Neurologic Associates P.C.
Patchogue, New York, United States, 11772
Island Neurological Associates, P.C.
Plainview, New York, United States, 11803
University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY at Stony Brook
Stony Brook, New York, United States, 11790
United States, North Carolina
The Neurological Institute PA
Charlotte, North Carolina, United States, 28204
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Neurology and Neuroscience Assoc., Inc.
Akron, Ohio, United States, 44320
United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Absher Neurology PA
Greenville, South Carolina, United States, 29607
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States, 37934
Advanced Neurosciences Institute
Nashville, Tennessee, United States, 37205
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Bhupesh Dihenia M.D. P.A.
Lubbock, Texas, United States, 79410
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Neurology Center of San Antonio
San Antonio, Texas, United States, 78212
Integra Clinical Research, Llc
San Antonio, Texas, United States, 78229
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Argentina
ALPI-Inst. de Rehabilitacion Marcelo Fitte
Buenos Aires, Argentina, C1425BWO
Instituto Nacional de Psicopatologia
Ciudad Autonoma Bs As, Argentina, 1405
STAT Research S.A.
Ciudad de Buenos Airesa, Argentina, C1013AAB
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, Argentina, 5400
Belarus
Grodno State Medical University
Grodno, Belarus, 230017
Republican Scientific-Practical Center Neurology
Minsk, Belarus, 220114
City Clinical Hospital #9
Minsk, Belarus, 220116
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus, 210032
Vitebsk; Regional Diagnostic Center
Vitebsk, Belarus, 210037
Belgium
CHU Charleroi-ISPPC-Espace Santé
Charleroi, Belgium, 6000
UZ Antwerpen
Edegem, Belgium, 2650
AZ Groeninge (Kennedylaan)
Kortrijk, Belgium, 8500
Bosnia and Herzegovina
University Clinic Ctr Sarajevo
Sarajevo, Bosnia and Herzegovina, 71 000
Uni Hospital Center Tuzla
Tuzla, Bosnia and Herzegovina, 75000
Brazil
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte, MG, Brazil, 30150-221
Hospital Maternidade Therezinha de Jesus - HMTJ
Juiz de Fora, MG, Brazil, 36025-330
Hospital Universitario Gaffree e Guinle; Neurologia
Rio de Janeiro, RJ, Brazil, 20270-004
Hospital das Clinicas - UNICAMP
Campinas, SP, Brazil, 13083-888
Hospital das Clinicas - FMUSP
Sao Paulo, SP, Brazil, 05403-000
Bulgaria
MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases
Sofia, Bulgaria, 1113
Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit
Sofia, Bulgaria, 1233
MHAT National Cardiology Hospital, EAD; Neurology
Sofia, Bulgaria, 1309
UMHAT Alexandrovska, EAD; Neurology
Sofia, Bulgaria, 1431
Canada, Alberta
Multiple Sclerosis Clinic
Calgary, Alberta, Canada, T2N 2T9
University of Alberta; Northern Alberta Trials & Research Centre
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
St. Michael's Hospital; Division of Neurology
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Clinique NeuroOutaouais
Gatineau, Quebec, Canada, J9J 0A5
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada, H3A 2B4
Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie
Montréal, Quebec, Canada, H1T 2M4
Colombia
Hospital Universitario San Ignacio
Bogota, Colombia, 000472
Croatia
General Hospital Pula
Pula, Croatia, 52100
General Hospital Varazdin
Varazdin, Croatia, 42000
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Uni Hospital Centre Dubrava
Zagreb, Croatia, 10000
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 613 00
Neurospol s.r.o.
Havirov, Czechia, 736 00
Pardubicka Krajska Nemocnice; Department of Neurology
Pardubice, Czechia, 532 03
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice, Czechia, 415 29
Krajska nemocnice Tomase Bati
Zlin, Czechia, 762 75
France
Hopital Neurologique Pierre Wertheimer
Bron, France, 69500
Hopital Henri Mondor; Service de Neurologie
Creteil, France, 94010
Hôpital General; Hôpital du Bocage - Service de neurologie
Dijon Cedex, France, 21079
Hôpital Saint Philibert
Lommé, France, 59462
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75651
Centre Hospitalier Intercommunal de Poissy
Poissy, France, 78300
Hôpital Maison Blanche; Service de Neurologie
Reims, France, 51092
Hopital Pontchaillou
Rennes, France, 35033
Hôpital Charles Nicolle; Service de Neurologie
Rouen, France, 76031
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse, France, 31059
Germany
Hofmann Werner
Aschaffenburg, Germany, 63739
Sozialstiftung Bamberg; Neurologische Klinik
Bamberg, Germany, 96049
Gemeinschaftspraxis Dres; Dept Apotheke
Berlin, Germany, 10243
Germania-Apotheke
Berlin, Germany, 12163
Neurologische Praxis Bonn
Bonn, Germany, 53117
Universitaetsklinikum Duesseldorf; Neurologische Klinik
Düsseldorf, Germany, 40225
Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, Germany, 45122
Zentrum fuer ambulante Neurologie
Essen, Germany, 45138
Universitaetsklinikum Frankfurt; Klinik für Neurologie
Frankfurt, Germany, 60528
Neurocentrum am Kreiskrankenhaus
Grevenbroich, Germany, 41515
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Krankenhaus Merheim Lungenklinik
Köln, Germany, 51109
Universitaetsklinikum Marburg; Klinik fuer Neurologie
Marburg, Germany, 35043
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Ratsapotheke Mittweida
Mittweida, Germany, 09648
Klinikum Grosshadern der LMU
Muenchen, Germany, 81377
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München, Germany, 81675
Villa Sauer, Praxis für; Neurologie und Psychiatrie
Siegen, Germany, 57072
Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber
Ulm, Germany, 89073
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Ireland
St Vincents University Hospital
Dublin 4, Ireland
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Lazio, Italy, 00133
Policlinico Universitario Agostino Gemelli
Roma, Lazio, Italy, 00168
A.O. Universitaria S. Martino Di Genova
Genova, Liguria, Italy, 16132
Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna
Milano, Lombardia, Italy, 20133
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari, Lombardia, Italy, 25018
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona, Marche, Italy, 60100
Ospedale degli Infermi
Biella, Piemonte, Italy, 13900
A.O. Universitaria S. Luigi Gonzaga Di Orbassano
Orbassano, Piemonte, Italy, 10043
Ospedale Generale Regionale F. Miulli; U.O.C. Neurologia
Acquaviva delle Fonti, Puglia, Italy, 70021
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Puglia, Italy, 70124
IRCCS Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Puglia, Italy, 71013
Fond. Ist. S. Raffaele - giglio
Cefalu, Sicilia, Italy, 90015
Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, Mexico, 20127
Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4
Chihuahua, Mexico, 31238
Hospital Angeles Culiacan; Neurociencias
Culiacan, Mexico, 80020
Hospital General de Culiacan Dr Bernardo Gastelum
Culiacan, Mexico, 80270
Hospital Mexico Americano SC; Departamento de Electroencefalografía
Guadalajara, Mexico, 44620
Mexico Centre for Clinical Research
Mexico, Mexico, 03100
AVIX Investigación Clínica S.C
Monterrey, Mexico, 64710
Clinical Research Institute
Tlalnepantla, Mexico, 54055
Norway
Haukeland Universitetssykehus
Bergen, Norway, 5021
Sykehuset i Vestfold HF
Tønsberg, Norway, 3103
Poland
Vitamed
Bydgoszcz, Poland, 85-021
Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
Jaroslaw, Poland, 37-500
M.A. - LEK A.M.Maciejowscy SC.
Katowice, Poland, 40-595
NEURO-CARE Gabriela Kłodowska
Katowice, Poland, 40-749
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, Poland, 31-505
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
Lodz, Poland, 90-153
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland, 90-324
Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie
Lublin, Poland, 20-954
Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym
Olsztyn, Poland, 10-561
Spsk Nr 1 Pomorskiej Akademii Medycznej; Klinika Neurologii
Szczecin, Poland, 71-252
mMED Maciej Czarnecki
Warszawa, Poland, 01-697
Russian Federation
State institution of health care - Territorial Clinical Hospital
Barnaul, Russian Federation, 656024
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan, Russian Federation, 420101
MHI Kirov City Clinical Hospital #1
Kirov, Russian Federation, 610014
Krasnoyarsk State Medical Academy
Krasnoyarsk, Russian Federation, 660022
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
Nizniy Novgorod, Russian Federation, 603155
Perm SMA n.a. academ. E.A. Vagner
Perm, Russian Federation, 614990
City Clinical Hospital#2
Pyatigorsk, Russian Federation, 357538
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint-Petersburg, Russian Federation, 197022
Saratov State Medical University of RosZdrav; Neurology
Saratov, Russian Federation, 410012
State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8
Yaroslavl, Russian Federation, 150030
Slovakia
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
Banska Bystrica, Slovakia, 974 04
Fakultna Nemocnica Roosevelta
Banska Bystrica, Slovakia, 975 17
Vseobecna nemocnica s poliklinikou Levoca a.s.
Levoca, Slovakia, 054 01
Martinska fakultna nemocnica
Martin, Slovakia, 036 59
Fakultna nemocnica s poliklinikou Nove Zamky; Neurologicka klinika
Nove Zamky, Slovakia, 940 34
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
Presov, Slovakia, 081 81
Spain
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General Univ. de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Madrid, Spain, 28007
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga, Spain, 29010
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia, Spain, 46010
Sweden
Sahlgrenska Sjukhuset; Neurology
Göteborg, Sweden, 413 45
Karolinska Universitetssjukhuset Huddinge; Neurology
Stockholm, Sweden, 14186
Karolinska Universitetssjukhuset Solna; Neurology
Stockholm, Sweden, 171 76
Norrlands Universitetssjukhus
Umea, Sweden, 901 85
Turkey
Hacettepe University Medical Faculty; Neurology
Ankara, Turkey, 06100
Haseki Training and Research Hospital
Istanbul, Turkey, 34096
Istanbul University Cerrahpasa Medical Faculty; Noroloji Anabilim Dali
Istanbul, Turkey, 34098
Istanbul Bilim Universty Medical Fac.
Istanbul, Turkey, 34394
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey, 34668
Ege University Medical Faculty
Izmir, Turkey, 35100
Dokuz Eylul University Medicine Faculty; Noroloji Departmani
Izmir, Turkey, 35340
Kocaeli University Medical Faculty
Kocaeli, Turkey, 41380
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, Turkey, 55139
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, Turkey, 61080
Izmir Tepecik Training and Research Hospital; Noroloji Klinigi
Yenisehir-Izmir, Turkey, 35120
Ukraine
Mun.Med.Proph.Inst."Chernihiv Reg.Hosp."; Neurology Department
Chernihiv, Ukraine, 14029
City Clinical Hospital #4
Dnipropetrovsk, Ukraine, 49102
State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a
Donetsk, Ukraine, 83045
Road Clinical Hospital of Donetsk Station; Neurology Department
Donetsk, Ukraine, 83114
Regional Clinical Hospital; Neurology Department
Ivano-Frankivsk, Ukraine, 76008
United Kingdom
Royal Sussex County Hospital, CIRU Level 5
Brighton, United Kingdom, BN2 5BE
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom, EX2 5DW
Kings College Hospital; Neurosciences Clinical Trials Office
London, United Kingdom, SE5 9NT
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
City General Hospital; Department of Neurology
Stoke on Trent, United Kingdom, ST4 6QG
Morriston Hospital
Swansea, United Kingdom, SA6 6NL
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01412333     History of Changes
Other Study ID Numbers: WA21093
2010-020315-36 ( EudraCT Number )
First Submitted: August 8, 2011
First Posted: August 9, 2011
Results First Submitted: March 30, 2017
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic


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