Multiple Sclerosis Clinical Trial
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the lower limit of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.
Diagnosis of primary progressive multiple sclerosis (PPMS).
Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive.
Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds
Score of >/= to 2.0 on the Functional Systems scale for the pyramidal system that was due to lower extremity findings at screening and baseline.
Documented MRI of brain with abnormalities consistent with MS
Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
Disease duration from the onset of MS symptoms; if EDSS score at screening is less or equal to 5, disease duration must be less than 10 years; If EDSS score at screening is more than 5, disease duration must be less than 15 years
Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands.
For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
For female participants without reproductive potential, may be enrolled if post-menopausal unless receiving a hormonal therapy for her menopause or if surgically sterile.
History of relapsing remitting or secondary progressive MS at screening.
Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
History of confirmed or suspected progressive multifocal leukoencephalopathy.
History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
Inability to complete an MRI or contraindication to gadolinium administration.
Contraindications to mandatory pre-medications for IRRs.
Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study.
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
Significant, uncontrolled disease that may preclude participant from participating in the study.
History of or currently active primary or secondary, non-drug-related, immunodeficiency.
Pregnant or breastfeeding or intending to become pregnant.
Lack of peripheral venous access.
History of alcohol or other drug abuse within 12 months prior to screening.
Treatment with any investigational agent or treatment with any experimental procedure for MS.
Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
Previous treatment with natalizumab within 4.5 months of baseline
Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication.
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
Any previous history of transplantation or anti-rejection therapy.
Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
Systemic corticosteroid therapy within 4 weeks prior to screening.
Positive screening tests for active, latent, or inadequately treated hepatitis B
Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.
Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
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There are 208 Locations for this study
Homewood Alabama, 35209, United States
Phoenix Arizona, 85004, United States
Tucson Arizona, 85718, United States
Irvine California, 92697, United States
Pasadena California, 91105, United States
Sacramento California, 95817, United States
Stanford California, 94305, United States
Torrance California, 90502, United States
Aurora Colorado, 80045, United States
Basalt Colorado, 81621, United States
Englewood Colorado, 80113, United States
Fort Collins Colorado, 80528, United States
Stamford Connecticut, 06905, United States
Boca Raton Florida, 33487, United States
Clearwater Florida, 33761, United States
Miami Florida, 33144, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Nicholasville Kentucky, 40356, United States
Scarborough Maine, 04074, United States
Lutherville Maryland, 21093, United States
Boston Massachusetts, 02114, United States
Foxboro Massachusetts, 02035, United States
Wellesley Massachusetts, 02481, United States
Worcester Massachusetts, 01655, United States
Farmington Hills Michigan, 48334, United States
Owosso Michigan, 48867, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Neptune New Jersey, 07753, United States
Great Neck New York, 11021, United States
New York New York, 10075, United States
Charlotte North Carolina, 28204, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Greenville South Carolina, 29605, United States
Cordova Tennessee, 38018, United States
Cordova Tennessee, 38018, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37205, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
San Antonio Texas, 78258, United States
Sherman Texas, 75092, United States
Norfolk Virginia, 23502, United States
Milwaukee Wisconsin, 53215, United States
Buenos Aires , C1424, Argentina
Buenos Aires , C1431, Argentina
Rosario , S2000, Argentina
Ath , 7800, Belgium
Overpelt , 3900, Belgium
Brasilia DF, 70200, Brazil
Goiania GO, 74605, Brazil
Curitiba PR, 81210, Brazil
Passo Fundo RS, 99010, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90110, Brazil
Porto Alegre RS, 90610, Brazil
Joinville SC, 89202, Brazil
Campinas SP, 13083, Brazil
Santo Andre SP, 09090, Brazil
Sao Paulo SP, 01228, Brazil
Sao Paulo SP, 05403, Brazil
Pleven , 5800, Bulgaria
Sofia , 1113, Bulgaria
Vancouver British Columbia, V6T 1, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3A 2, Canada
Quebec , G1W 4, Canada
Brno , 656 9, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 2 , 12808, Czechia
Aalborg , 9000, Denmark
Glostrup , 2600, Denmark
Odense C , 5000, Denmark
Besançon , 25030, France
Brest , 29609, France
Bron , 69677, France
Caen , 14033, France
Clermont Ferrand , 63003, France
Lille , 59000, France
Nancy , 54035, France
Strasbourg , 67098, France
Bonn , 53111, Germany
Dresden , 01307, Germany
Greifswald , 17475, Germany
Göttingen , 37075, Germany
Halle (Saale) , 06120, Germany
Hannover , 30625, Germany
Jena , 07747, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Marburg , 35043, Germany
Münster , 48149, Germany
Neuburg , 86633, Germany
Stuttgart , 70178, Germany
Trier , 54292, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Wiesbaden , 65191, Germany
Athens , 115 2, Greece
Athens , 115 2, Greece
Larisa , 411 1, Greece
Thessaloniki , 546 3, Greece
Budapest , 1145, Hungary
Budapest , 1152, Hungary
Gyor , 9024, Hungary
Kaposvár , 7400, Hungary
Kistarcsa , 2143, Hungary
Napoli Campania, 80131, Italy
Napoli Campania, 80138, Italy
Roma Lazio, 00152, Italy
Roma Lazio, 00189, Italy
Bergamo Lombardia, 24127, Italy
Gallarate Lombardia, 21013, Italy
Milano Lombardia, 20132, Italy
Pavia Lombardia, 27100, Italy
Torino Piemonte, 10126, Italy
Cagliari Sardegna, 09126, Italy
Siena Toscana, 53100, Italy
Guadalajara Jalisco, 44130, Mexico
Ciudad de México Mexico CITY (federal District), 03600, Mexico
Mexico City Mexico CITY (federal District), 06700, Mexico
San Luis Potosí SAN LUIS Potosi, 78216, Mexico
La Victoria, Lima , Lima , Peru
Lima , 15003, Peru
Lima , Lima , Peru
Trujillo , 13009, Peru
Bydgoszcz , 85-79, Poland
Gdansk , 80-80, Poland
Katowice , 40-59, Poland
Konskie , 26-20, Poland
Krakow , 31-63, Poland
Lodz , 90-32, Poland
Lublin , 20-41, Poland
Olsztyn , 10-56, Poland
Oswiecim , 32-60, Poland
Plewiska , 62-06, Poland
Pozna? , 60-30, Poland
Rybnik , 44-20, Poland
Rzeszów , 35-23, Poland
Siemianowice ?l?skie , 41-10, Poland
Szczecin , 70-11, Poland
Warszawa , 01-68, Poland
Warszawa , 02-95, Poland
Warszawa , 04-14, Poland
Almada , 2801-, Portugal
Braga , 4710-, Portugal
Lisboa , 1169-, Portugal
Lisboa , 1349-, Portugal
Porto , 4099-, Portugal
Setúbal , 2910-, Portugal
Guaynabo , 00968, Puerto Rico
UFA Baskortostan, 45000, Russian Federation
Krasnoyarsk Krasnojarsk, 66003, Russian Federation
Krasnoyarsk Krasnojarsk, 66004, Russian Federation
Sankt-peterburg Leningrad, 19711, Russian Federation
Moscow Moskovskaja Oblast, 12536, Russian Federation
Moskva Moskovskaja Oblast, 11799, Russian Federation
Moskva Moskovskaja Oblast, 12701, Russian Federation
Sankt-petersburg Sankt Petersburg, 19737, Russian Federation
St Petersburg Sankt Petersburg, 19429, Russian Federation
St. Petersburg Sankt Petersburg, 19770, Russian Federation
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Kazan Tatarstan, 42004, Russian Federation
Ulyanovsk Uljanovsk, 43206, Russian Federation
Kirov , 61000, Russian Federation
Krasnodar , 35008, Russian Federation
Novosibirsk , 63000, Russian Federation
Perm , 61499, Russian Federation
Pozuelo de Alarcon Madrid, 28223, Spain
EL Palmar (EL Palmar) Murcia, 30120, Spain
Barcelona , 08035, Spain
Madrid , 28222, Spain
Aarau , 5001, Switzerland
Bern , 3010, Switzerland
Lugano , 6903, Switzerland
Ankara , 06500, Turkey
Istanbul , 34096, Turkey
Istanbul , 34098, Turkey
Istanbul , 34785, Turkey
Istanbul , 42131, Turkey
Kayseri , 38039, Turkey
Kocaeli , 41380, Turkey
Lzmir , 35100, Turkey
Merkez , 58060, Turkey
Mersin , 33079, Turkey
Samsun , 55139, Turkey
Çankaya , 06490, Turkey
Kyiv Chernihiv Governorate, 02123, Ukraine
Zaporizhzhia Katerynoslav Governorate, 69600, Ukraine
Kharkiv Kharkiv Governorate, 61058, Ukraine
Kharkiv Kharkiv Governorate, 61068, Ukraine
Cherkasy KIEV Governorate, 18029, Ukraine
Dnipro KIEV Governorate, 49027, Ukraine
Kyiv KIEV Governorate, 03037, Ukraine
Lviv KIEV Governorate, 79010, Ukraine
Vinnytsia Podolia Governorate, 21009, Ukraine
Sumy Polissya Okruha, 40031, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Kharkov , 61068, Ukraine
Lutsk , 43024, Ukraine
Cardiff , CF14 , United Kingdom
London , W6 8R, United Kingdom
London , WC1 3, United Kingdom
Newcastle upon Tyne , NE1 4, United Kingdom
Nottingham , NG7 2, United Kingdom
Plymouth , PL6 8, United Kingdom
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