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A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (O'HAND)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035005
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

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

Detailed Description:
The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 120 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. In the FU1 phase, all participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants who receive post-double progression ocrelizumab (PDP OCR) treatment, other immunomodulatory or immunosuppressive treatment(s) for MS, commercial ocrelizumab, or no treatment. The FU1 phase will run in parallel with the double-blind treatment phase until the primary analysis is performed. If the primary analysis is positive, an optional OLE phase is planned for eligible participants who either have remained in the double-blind treatment phase or are on PDP OCR treatment at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The follow-up 2 (FU2) phase will begin after the primary analysis is performed. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 and not on PDP OCR treatment at the time of primary analysis; participants who are ongoing in the double-blind treatment phase or receiving PDP OCR at the time of the primary analysis and do not enter the OLE phase; participants who complete or withdraw from the OLE phase. At the end of the FU2, all participants will move into B-cell monitoring (BCM) phase until the end of the study. This study will end when all participants who are not being treated with an alternative B-cell depleting therapy have repleted his or her B-cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 4, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Ocrelizumab
Participants will receive ocrelizumab by IV infusion every 24 weeks.
Drug: Ocrelizumab
The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 22 weeks between each dose of ocrelizumab.
Other Name: Ocrevus

Placebo Comparator: Placebo
Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.
Drug: Placebo
The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 22 weeks between each dose of placebo.




Primary Outcome Measures :
  1. Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks [ Time Frame: Baseline up to approximately 5.5 years ]
    20% increase from baseline in Nine-Hole Peg Test (9-HPT) confirmed for at least 12 weeks.


Secondary Outcome Measures :
  1. Time to Upper Limb Disability Progression Confirmed For at Least 24 Weeks [ Time Frame: Baseline up to approximately 5.5 years ]
    20% increases from baseline in 9-HPT confirmed for at least 24 weeks.

  2. Time to Disability Progression Confirmed For at Least 12 Weeks [ Time Frame: Baseline up to approximately 5.5 years ]
    Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.

  3. Time to Disability Progression Confirmed For at Least 24 Weeks [ Time Frame: Baseline up to approximately 5.5 years ]
    Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.

  4. Percent Change in Total Volume of T2 Lesions on MRI [ Time Frame: Baseline up to week 120 ]
  5. Percent Change in Total Brain Volume on MRI Scans [ Time Frame: Week 24 to Week 120 ]
  6. Proportion of Participants with Adverse Events [ Time Frame: Baseline up to 8.5 years ]
  7. Proportion of Participants With Serious Adverse Events [ Time Frame: Baseline up to 8.5 years ]
  8. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab [ Time Frame: Baseline, Weeks 2, 12, 24, 48, 60, 72, and every 12 weeks till the end of the double-blind period and Weeks 0 and 48 of the OLE period ]
  9. Evaluation of Ocrelizumab Pharmacodynamics, as measured by B-Cell Levels in Blood [ Time Frame: Baseline, Weeks 2, 24, 48, 72 and every 12 weeks till the end of the double-blind period and Weeks 0, 22, 46, 70 and 96 of the OLE period ]


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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EDSS score at screening and baseline >= 3.0 to 8.0, inclusive
  • Disease duration from the onset of MS symptoms:

Less than 15 years in patients with an EDSS at screening > 5.0 Less than 10 years in patients with an EDSS at screening <= 5.0

  • Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated IgG index or one or more IgG oligoclonal bands detected by isoelectric focusing
  • Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)
  • Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
  • Patients previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female patients without reproductive potential: Women may be enrolled if post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

Exclusion Criteria:

  • History of relapsing-remitting or secondary progressive MS at screening
  • Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease
  • Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML)
  • Known active malignancy or are being actively monitored for recurrence of malignancy
  • Immunocompromised state
  • Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
  • Inability to complete an MRI or contraindication to Gd administration.
  • Patients requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Patients must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization.
  • Contraindications to mandatory premedications for infusion-related reactions, including:

uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines

  • Known presence of other neurologic disorders
  • Pregnant or breastfeeding, or intending to become pregnant during the study and 6 months after last infusion of the study drug
  • Lack of peripheral venous access
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of alcohol or other drug abuse
  • History of primary or secondary immunodeficiency
  • Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
  • Previous treatment with B-cell targeting therapies
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Any previous history of transplantation or anti-rejection therapy
  • Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • Positive serum hCG measured at screening or positive urine β-hCG at baseline
  • Positive screening tests for hepatitis B
  • Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
  • Lack of MRI activity at screening/baseline if more than 650 patients without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 patients with MRI activity will be randomized

Eligibility Criteria for Open-Label Extension Phase:

  • Completed the double-blind treatment phase of the trial or have received PDP OCR in the FU1 phase, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Patients who withdrew from study treatment and received another disease-modifying therapy (DMT) or commercial ocrelizumab will not be allowed to enter in the OLE phase.
  • Meet the re-treatment criteria for ocrelizumab
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female patients without reproductive potential: Women may be enrolled if post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

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): NCT04035005


Contacts
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Contact: Reference Study ID Number: WA40404 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
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United States, California
Arcadia Neurology Center Recruiting
Arcadia, California, United States, 91006
Arcadia Neurology Center Not yet recruiting
Arcadia, California, United States, 91006
Multiple Sclerosis Center of California Not yet recruiting
Newport Beach, California, United States, 92663
United States, District of Columbia
Georgetown University Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
SFM Clinical Research, LLC Recruiting
Boca Raton, Florida, United States, 33487
MS and Neuromuscular Center of Excellence Recruiting
Clearwater, Florida, United States, 33761
Neurological Services of Orlando Recruiting
Orlando, Florida, United States, 32806
Vero Neurology Recruiting
Vero Beach, Florida, United States, 32960
United States, Illinois
Consultants in Neurology Ltd Not yet recruiting
Northbrook, Illinois, United States, 60062
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
Michigan Neurology Associates P.C. Recruiting
Clinton Township, Michigan, United States, 48035
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Michigan Institute for Neurological Disorders Not yet recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic - PPDS Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198-7835
United States, New Mexico
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Dent Neurological Institute Recruiting
Amherst, New York, United States, 14226
State University of New York at Buffalo; Department of Neurology Not yet recruiting
Buffalo, New York, United States, 14203
United States, Ohio
Neurology and Neuroscience Assoc., Inc. Not yet recruiting
Westerville, Ohio, United States, 43081
United States, Pennsylvania
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Albert Einstein Medical Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Premier Neurology Not yet recruiting
Greer, South Carolina, United States, 29650
United States, Tennessee
Vanderbilt MS Clinic Not yet recruiting
Nashville, Tennessee, United States, 37215
United States, Texas
Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
Meridian Clinical Research Not yet recruiting
Norfolk, Virginia, United States, 23502
Australia, New South Wales
Brain and Mind Research Institute Not yet recruiting
Camperdown, New South Wales, Australia, 2050
John Hunter Hospital Not yet recruiting
New Lambton, New South Wales, Australia, 2305
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital Not yet recruiting
Parkville, Victoria, Australia, 3050
Austria
Medizinische Universitat Graz Not yet recruiting
Graz, Austria, 8036
Kepler Universitatsklinikum Linz Not yet recruiting
Linz, Austria, 4021
Christian-Doppler-Klinik Salzburg Not yet recruiting
Salzburg, Austria, 5020
Belgium
Cliniques Universitaires St-Luc Not yet recruiting
Bruxelles, Belgium, 1200
UZ Antwerpen Not yet recruiting
Edegem, Belgium, 2650
CHU Tivoli Not yet recruiting
La Louvière, Belgium, 7100
Chr de La Citadelle Not yet recruiting
Liège, Belgium, 4000
Brazil
L2 Ip Instituto de Pesquisas Clinicas Ltda ME Not yet recruiting
Brasilia, DF, Brazil, 70200-730
Hospital Das Clinicas Da Universidade Federal de Goias Not yet recruiting
Goiania, GO, Brazil, 74110-030
Santa Casa de Misericordia de Belo Horizonte Not yet recruiting
Belo Horizonte, MG, Brazil, 30150-221
Nucleo de Pesquisa Clinica Not yet recruiting
Curitiba, PR, Brazil, 80730-150
Hospital Sao Vicente de Paulo Not yet recruiting
Passo Fundo, RS, Brazil, 99010-090
Associacao Hospitalar Moinhos de Vento Not yet recruiting
Porto Alegre, RS, Brazil, 90560-030
Hospital Sao Lucas da PUCRS Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
Pesquisa Medica Praxis Not yet recruiting
Santo Andre, SP, Brazil, 09090-790
Bulgaria
Military Medical Academy HBAT Not yet recruiting
Pleven, Bulgaria, 5800
Multiprofile Hospital For Active Treatment Avis Medica Not yet recruiting
Pleven, Bulgaria, 5800
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD Not yet recruiting
Sofia, Bulgaria, 1113
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Vancouver Hospital Ubc Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
University of Toronto Not yet recruiting
Toronto, Ontario, Canada, M5G 1Z6
Canada, Quebec
Clinique Neuro Outaouais Not yet recruiting
Gatineau, Quebec, Canada, J8Y 1W2
Recherche Sepmus, Inc. Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Colombia
Fundacion Cardioinfantil Instituto Cardiologico Not yet recruiting
Bogota DC, Colombia, 110131
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia Not yet recruiting
Bogota, Colombia, 111321
Sociedad de Cirugia de Bogota Hospital San Jose Not yet recruiting
Bogota, Colombia
Instituto Neurologico de Colombia INDEC Not yet recruiting
Medellin, Colombia
Croatia
Clinical Hospital Centre Osijek Not yet recruiting
Osijek, Croatia, 31000
General Hospital Varazdin Not yet recruiting
Varazdin, Croatia, 42000
Clinical Hospital Sestre Milosrdnice Not yet recruiting
Zagreb, Croatia, 10 000
University Hospital Center Zagreb Not yet recruiting
Zagreb, Croatia, 10000
Egypt
Ain Shams University Hospital Not yet recruiting
Cairo, Egypt, 11566
Clinical Research Center-Alex university; Neurology Department Not yet recruiting
Cairo, Egypt, 21561
Azhar University Hospital Not yet recruiting
Cairo, Egypt
France
CHU Amiens Hopital Sud; Neurologie Not yet recruiting
Amiens Cedex1, France, 80054
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin Not yet recruiting
Bordeaux, France, 33076
Hopital Pierre Wertheimer - Hopital Neurologique Not yet recruiting
Bron, France, 69677
Centre Hospitalier Universitaire de Clermont Ferrand Not yet recruiting
Clermont-ferrand, France, 63000
Hopital de Colmar Not yet recruiting
Colmar, France, 68000
Hopital Saint Vincent de Paul - GHICL Lille - Parent Not yet recruiting
Lille, France, 59020
Hopitaux de La Timone Not yet recruiting
Marseille, France, 13385
CHU Gui de Chauliac Not yet recruiting
Montpellier, France, 34000
CHRU Nancy Not yet recruiting
Nancy, France, 54035
Hopital Guillaume Et Rene Laennec Not yet recruiting
Nantes, France, 44805
CHU de Nimes - Hopital Universitaire Caremeau Not yet recruiting
Nimes, France, 30900
Groupe Hospitalier Paris Saint Joseph Not yet recruiting
Paris, France, 75014
Hopital de Hautepierre; Service de Neurologie Not yet recruiting
Strasbourg, France, 67098
Georgia
Pineo Medical Ecosystem LTD Not yet recruiting
Tbilisi, Georgia, 0114
Tbilisi State Medical University Not yet recruiting
Tbilisi, Georgia, 0141
Khechinashvili University Hospital Not yet recruiting
Tbilisi, Georgia, 179
Germany
Neurologische Praxis Dr. med. Irma Schoell Not yet recruiting
Bad Homburg, Germany, 61348
Klinikum Bayreuth GmbH Not yet recruiting
Bayreuth, Germany, 95445
Marianne-Strauß-klinik Not yet recruiting
Berg, Germany, 82335
Charite - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 12203
Judisches Krankenhaus Not yet recruiting
Berlin, Germany, 13347
Ruhr Universitat Bochum Not yet recruiting
Bochum, Germany, 44791
Universitätsklinikum Carl Gustav Carus an der TU Dresden Not yet recruiting
Dresden, Germany, 01307
Universitatsklinikum Frankfurt Not yet recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
Universitatsklinikum Gießen und Marburg GmbH Not yet recruiting
Gießen, Germany, 35385
University Medicine Gottingen Germany Not yet recruiting
Göttingen, Germany, 37075
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
DataMed GmbH Not yet recruiting
Köln, Germany, 50935
Universitatsklinikum Leipzig Not yet recruiting
Leipzig, Germany, 04103
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Not yet recruiting
Mainz, Germany, 55101
Klinikum Grosshadern der LMU Not yet recruiting
Muenchen, Germany, 81377
Universitätsklinikum Münster Not yet recruiting
Münster, Germany, 48149
St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH Not yet recruiting
Potsdam, Germany, 14471
Neurozentrum Prien Not yet recruiting
Prien, Germany, 83209
Klinikum der Universitat Regensburg Not yet recruiting
Regensburg, Germany, 93053
Universitatsklinik Rostock Not yet recruiting
Rostock, Germany, 18147
Universitätsklinikum Tübingen Not yet recruiting
Tuebingen, Germany, 72076
Fachklinik für Neurologie Dietenbronn GmbH Not yet recruiting
Ulm-Schwendi, Germany, 88477
Universitaetsklinikum Ulm Not yet recruiting
Ulm, Germany, 89081
Hungary
Bacs-Kiskun Megyei Korhaz Not yet recruiting
Kecskemet, Hungary, 6000
Szent Borbala Korhaz Not yet recruiting
Tatabánya, Hungary, 2800
Ireland
Saint Vincent's University Hospital Not yet recruiting
Dublin, Ireland, Dublin 4
Italy
AOU dell'Università degli Studi della Campania Luigi Vanvitelli Not yet recruiting
Napoli, Campania, Italy
Fondazione PTV Policlinico Tor Vergata Not yet recruiting
Rome, Lazio, Italy, 00133
Azienda Ospedaliera Sant'andrea Not yet recruiting
Rome, Lazio, Italy, 00189
Ospedale Policlinico San Martino Not yet recruiting
Genova, Liguria, Italy, 16132
Ospedale San Raffaele S.r.l. - PPDS Not yet recruiting
Milano, Lombardia, Italy, 20132
ASST degli Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari Not yet recruiting
Montichiari, Lombardia, Italy, 25018
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS Not yet recruiting
Pavia, Lombardia, Italy, 27100
Azienda Sanitaria Ospedaliera S Luigi Gonzaga Not yet recruiting
Orbassano, Piemonte, Italy, 10043
Fondazione Istituto G. Giglio di Cefalu Not yet recruiting
Cefalù, Sicilia, Italy, 90015
Azienda Ospedaliera di Padova; Clinica Neurologica Not yet recruiting
Padova, Veneto, Italy, 35128
Mexico
Hospital Civil Fray Antonio Alcalde Not yet recruiting
Guadalajara, Jalisco, Mexico, 44280
Centro de Diagnostico Neurofisiologico S.C Not yet recruiting
Mexico City, Mexico CITY (federal District), Mexico, 01600
Unidad de Investigacion en Salud de Chihuahua Not yet recruiting
Mexico City, Mexico CITY (federal District), Mexico, 14390
Neurociencias Estudios Clinicos S.C. Not yet recruiting
Culiacán, Sinaloa, Mexico, 80020
Scientia Investigacion Clinica S.C. Not yet recruiting
Chihuahua, Mexico, 31203
Hospital Angeles Chihuahua Not yet recruiting
Chihuahua, Mexico, 31238
Grupo Medico Camino Not yet recruiting
DF, Mexico, 03310
Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Not yet recruiting
Durango, Mexico, 34000
Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX Withdrawn
Monterrey, Mexico, 64050
Clinical Research Institute Not yet recruiting
Tlalnepantla, Mexico, 54055
Netherlands
Jeroen Bosch Ziekenhuis Not yet recruiting
'S Hertogenbosch, Netherlands, 5223 GZ
Ziekenhuis Rijnstate Not yet recruiting
Arnhem, Netherlands, 6815 AD
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands, 4819 EV
Zuyderland Medisch Centrum Not yet recruiting
Sittard-Geleen, Netherlands, 6162 BG
New Zealand
Christchurch Hospital Not yet recruiting
Christchurch, New Zealand, 8011
Dunedin Hospital Not yet recruiting
Dunedin, New Zealand
Waikato Hospital; Neurology Not yet recruiting
Hamilton, New Zealand, 3240
Wellington Hospital; Department of Neurology Not yet recruiting
Wellington, New Zealand, 6021
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku Not yet recruiting
Bialystok, Poland, 15-276
Specjalistyczna Praktyka Lekarska Pawel Bochniak. Not yet recruiting
Bydgoszcz, Poland, 85-795
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny Not yet recruiting
Gdansk, Poland, 80-803
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM Recruiting
Katowice, Poland, 40-571
RESMEDICA Spolka z o.o. Not yet recruiting
Kielce, Poland, 25-726
Oddzial Kliniczny Neurologii Not yet recruiting
Kraków, Poland, 31-501
Centrum Neurologii Krzysztof Selmaj Not yet recruiting
Lodz, Poland, 90-324
Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak Not yet recruiting
Lublin, Poland, 20-605
Wojewódzki Szpital Specjalistyczny w Olsztynie; Oddział Kliniczny Neurologii, Oddział Udarowy Not yet recruiting
Olsztyn, Poland, 10-561
Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa Not yet recruiting
Poznań, Poland, 60-848
Wojewódzki Szpital Specjalistyczny Nr 3 Not yet recruiting
Rybnik, Poland, 44-200
Centrum Medyczne "MEDYK" Not yet recruiting
Rzeszow, Poland, 35-055
NZOZ EroMedis Not yet recruiting
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect Not yet recruiting
Warszawa, Poland, 01-684
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna Not yet recruiting
Warszawa, Poland, 02-957
Miedzyleski Szpital Specjalistyczny w Warszawie Not yet recruiting
Warszawa, Poland, 04-749
EMC Instytut Medyczny S.A. Not yet recruiting
Wrocław, Poland, 50-220
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego Not yet recruiting
Zabrze, Poland, 41-803
Portugal
Hospital de Braga Not yet recruiting
Braga, Portugal, 4710-243
Hospital Beatriz Angelo Not yet recruiting
Loures, Portugal, 2674-514
Centro Hospitalar do Porto - Hospital de Santo António Not yet recruiting
Porto, Portugal, 4099-001
Campus Neurologico Senior Not yet recruiting
Torres Vedras, Portugal, 2560-280
Romania
Colentina Clinical Hospital Not yet recruiting
Bucharest, Romania, 020125
Emergency University Hospital Not yet recruiting
Bucharest, Romania, 050098
SC Clubul Sanatatii SRL Not yet recruiting
Campulung, Romania, 115100
County Hospital Caracal Not yet recruiting
Caracal, Romania, 235200
Cai Ferate Clinical Hospital Not yet recruiting
Constanta, Romania, 90123
Spitalul Municipal Dr.Alexandru Simionescu Hunedoara Not yet recruiting
Hunedoara, Romania, 331057
Targu Mures Clinical Emergency County Hospital Not yet recruiting
Targu Mures, Romania, 540100
Russian Federation
State Healthcare Institution Territorial Clinical Hospital Not yet recruiting
Barnaul, Altaj, Russian Federation, 656024
Kuvatov Republican Clinical Hospital Not yet recruiting
UFA, Baskortostan, Russian Federation, 450005
Research Center of Neurology of RAMS Not yet recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 125367
Moscow Regional Research Clinical Institute Na Mfvladimirskiy Not yet recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 129110
City Out Patient Clinic For Rehabilitation Treatment #7 Not yet recruiting
Moskva, Moskovskaja Oblast, Russian Federation, 105005
City Clinical Hospital #15 n.a. N.F. Filatov Not yet recruiting
Moskva, Moskovskaja Oblast, Russian Federation, 111539
Russian National Research Medical University n.a. N.I.Pirogov Not yet recruiting
Moskva, Moskovskaja Oblast, Russian Federation, 117997
Neftyanik Medical and Sanitary Unit Not yet recruiting
Tumen, Moskovskaja Oblast, Russian Federation, 625000
City Clinical Hospital #12 Not yet recruiting
Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603003
Nizhniy Novgorod City Hospital #33 Not yet recruiting
Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603005
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31 Not yet recruiting
Sankt-peterburg, Sankt Petersburg, Russian Federation, 197110
City Hospital #40 of Kurortniy Administrative District Not yet recruiting
St. Petersburg, Sankt Petersburg, Russian Federation, 197706
Yaroslavl Clinical Hospital #8 Not yet recruiting
Yaroslavl, Sankt Petersburg, Russian Federation, 150030
City Clinical Hospital #4 Not yet recruiting
Saransk, Saratov, Russian Federation, 430032
Republican Clinical Hospital For Rehabilitation Treatment Not yet recruiting
Kazan, Tatarstan, Russian Federation, 420021
Ulyanovsk Regional Clinical Hospital Not yet recruiting
Ulyanovsk, Uljanovsk, Russian Federation, 432063
Belgorod Regional Clinical Hospital Not yet recruiting
Belgorod, Russian Federation, 308007
Sverdlovsk Regional Clinical Hospital 1 Not yet recruiting
Ekaterinburg, Russian Federation, 620102
Kemerovo Regional Clinical Hospital Not yet recruiting
Kemerovo, Russian Federation, 650066
Kirov State Medical Academy Not yet recruiting
Kirov, Russian Federation, 610027
Krasnoyarsk State Medical Academy Not yet recruiting
Krasnoyarsk, Russian Federation, 660022
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department Not yet recruiting
Nizniy Novgorod, Russian Federation, 603155
FSBIH Siberian Regional Medical Centre of FMBA of Russia Not yet recruiting
Novosibirsk, Russian Federation, 630007
Novosibirsk State Regional Clinical Hospital Not yet recruiting
Novosibirsk, Russian Federation, 630087
Perm SMA n.a. academ. E.A. Vagner Not yet recruiting
Perm, Russian Federation, 614990
Siberian State Medical University of Roszdrav Not yet recruiting
Tomsk, Russian Federation, 634050
Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital Not yet recruiting
Tver, Russian Federation
Serbia
Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Military Medical Academy Not yet recruiting
Belgrade, Serbia, 11040
Clinical Center Kragujevac Not yet recruiting
Kragujevac, Serbia, 34000
Clinical Center Nis Not yet recruiting
NIS, Serbia, 18000
Clinical Centre of Vojvodina Not yet recruiting
Nova Sad, Serbia, 21000
General Hospital Uzice Not yet recruiting
Uzice, Serbia, 31000
Clinical Hospital Centre Zemun Not yet recruiting
Zemun, Serbia, 11080
Spain
Hospital Universitario Quironsalud Madrid Recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Complejo Hospitalario Universitario de Vigo Recruiting
Vigo, Pontevedra, Spain, 36204
Hospital Universitario Virgen Macarena Recruiting
Seville, Sevilla, Spain, 41071
Hospital Universitario Cruces Recruiting
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitario Vall d'Hebron - PPDS Recruiting
Barcelona, Spain, 08035
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Hospital General de Castellon Recruiting
Castellon, Spain, 12004
Hospital Universitario Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Hospital Universitario HM Sanchinarro-CIOCC Not yet recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro - Majadahonda Not yet recruiting
Madrid, Spain, 28222
Hospital Regional Universitario de Malaga - Hospital General Recruiting
Malaga, Spain, 29010
Hospital Universitario Virgen de La Arrixaca Not yet recruiting
Murcia, Spain, 30120
Complejo Asistencial Universitario de Salamanca - H. Clinico Not yet recruiting
Salamanca, Spain, 37007
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Ukraine
Medical Centre of PE First Private Clinic Not yet recruiting
Zhytomir, Crimean Regional Governmenta, Ukraine, 10008
Medical Center Dopomoga Plus Not yet recruiting
Kyiv, Katerynoslav Governorate, Ukraine, 03143
Zaporizhzhya State Medical University Not yet recruiting
Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69600
Zaporizhia City Multispecialty Clinical Hospital #9 Not yet recruiting
Zaporizhzhye, Katerynoslav Governorate, Ukraine, 69063
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital Not yet recruiting
Kharkiv, Kharkiv Governorate, Ukraine, 61058
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Not yet recruiting
Lviv, Kharkiv Governorate, Ukraine, 79010
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov Not yet recruiting
Dnipro, Kherson Governorate, Ukraine, 49000
LLC Medical Center Family Medicine Clinic Not yet recruiting
Dnipro, Kherson Governorate, Ukraine, 49600
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh Not yet recruiting
Kherson, Kherson Governorate, Ukraine, 73000
Medical Center of LLC MRT Elit Not yet recruiting
Kropyvnytsiy, Kherson Governorate, Ukraine, 25005
Medical Center of LLC Medical Clinic Blagomed Not yet recruiting
Kyiv, KIEV Governorate, Ukraine, 01001
Medical Clinical Research Center of Medical Center LLC Health Clinic Not yet recruiting
Vinnytsi, Podolia Governorate, Ukraine, 21009
Municipal Institution Vinnytsia Regional Psychoneurological Hospital n.a. O.I. Yushchenko Not yet recruiting
Vinnytsya, Podolia Governorate, Ukraine, 21005
Regional Clinical Hospital Not yet recruiting
Ivano-Frankivsk, Ukraine, 76018
Kyiv City Clinical Hospital #4 Not yet recruiting
Kyiv, Ukraine, 03110
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Not yet recruiting
Kyiv, Ukraine, 04107
Volyn Regional Clinical Hospital Not yet recruiting
Lutsk, Ukraine, 43024
United Kingdom
University Hospital of Wales Not yet recruiting
Cardiff, United Kingdom, CF14 4XW
Queen Elizabeth University Hospital - PPDS Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Raigmore Hospital - PPDS Not yet recruiting
Inverness, United Kingdom, IV2 3UJ
Walton Centre For Neurology and Neurosurgery Not yet recruiting
Liverpool, United Kingdom, L9 7LJ
The National Hospital for Neurology & Neurosurgery Not yet recruiting
London, GT LON, United Kingdom, WC1N 3BG
The Royal London Hospital Not yet recruiting
London, United Kingdom, E1 1BB
University of Nottingham Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Peninsula College of Medicine and Dentistry Not yet recruiting
Plymouth, United Kingdom, PL6 8BX
Salford Royal Hospital Not yet recruiting
Salford, United Kingdom, M6 8HD
Royal Hallamshire Hospital Not yet recruiting
Sheffield, United Kingdom, S10 2JF
Morriston Hospital Not yet recruiting
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04035005     History of Changes
Other Study ID Numbers: WA40404
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs