Phase
Condition
Memory Loss
Scar Tissue
Multiple Sclerosis
Treatment
Lumbar Puncture
Methyloprednisolone
Ocrelizumab
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
General Inclusion Criteria:
- For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods that result in a failure rateof <1 percent (%) per year during the treatment period and for at least 24 weeksafter the last dose of study treatment or until their B-cells have repleted,whichever is longer
Inclusion Criteria Specific to RMS Participants:
Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, atScreening
Disease duration from the onset of multiple sclerosis symptoms less than (<) 15years in participants with an EDSS score greater than (>) 5.0 at Screening
Either treatment-naive or receiving treatment with disease-modifying therapies,including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).
At least one clinically documented relapse in the past year and/or at least oneT1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least onenew T2 lesion in the past year at the time of enrollment
Inclusion Criteria Specific to RMS Cohort Arm 4 Participants:
Must meet inclusion criteria for the RMS cohort
Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4)
Must be willing to remain on the same dose and regimen of current standard of care,or no treatment if treatment-naïve, for 12 weeks after study enrollment The treatingand/or study physician must agree that the participant is eligible to remain on thesame dose and regimen of their current standard of care at Screening, or to receiveno treatment if the participant is treatment-naïve, for 12 weeks after studyenrollment
Inclusion Criteria Specific to PPMS Participants:
Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria
EDSS score of 3.0 - 6.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms <10 years inparticipants with an EDSS at Screening less than or equal to (</=) 5.0
Documented history of either elevated immunoglobulin G (IgG) Index or one or moreIgG oligoclonal bands (OCBs) detected by isoelectric focusing
Exclusion
Exclusion Criteria:
Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year
History or known presence of recurrent or chronic infection (e.g., humanimmunodeficiency virus [HIV], syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History of cancer, including solid tumors and hematological malignancies (exceptbasal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma ofthe cervix of the uterus that have been excised and resolved with documented cleanmargins on pathology)
History of or currently active primary or secondary immunodeficiency
History of coagulation disorders
History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal antibodies
History of alcohol or other drug abuse within 24 weeks prior to enrollment
Known presence or history of other neurologic disorders Significant, uncontrolleddisease, such as cardiovascular (including cardiac arrhythmia), pulmonary (includingchronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal,or any other significant disease
Congestive heart failure (according to New York Heart Association III or IVfunctional severity)
Known active bacterial, viral, fungal, mycobacterial infection, or any major episodeof infection requiring hospitalization or treatment with IV antibiotics
Any concomitant disease that may require chronic treatment with systemiccorticosteroids or immunosuppressants during the course of the study
Contraindications or intolerance to oral or IV corticosteroids, including IVmethylprednisolone, according to the country label
Contraindication for LP
Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab,atacicept, belimumab, or ofatumumab)
Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents,cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine,mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bonemarrow transplantation
Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similartreatment within 6 months prior to enrollment
Receipt of a live vaccine within 6 weeks prior to enrollment
Systemic corticosteroid therapy within 4 weeks prior to Baseline
Previous or concurrent treatment with any investigational agent or treatment withany experimental procedure for multiple sclerosis (such as treatment for chroniccerebrospinal venous insufficiency)
Certain laboratory abnormalities or findings at Screening
Inability to complete an MRI
Lack of peripheral venous access
Pregnant or lactating, or intending to become pregnant during the study
Exclusion Criteria Specific to RMS Participants:
- Diagnosis of PPMS or secondary progressive multiple sclerosis without relapses
Study Design
Connect with a study center
University of Alberta Hospital
Edmonton, Alberta T6G1Z1
CanadaSite Not Available
University of British Columbia Hospital Site; Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia V6T 1Z3
CanadaSite Not Available
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec H3A 2B4
CanadaSite Not Available
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
GermanySite Not Available
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
GermanySite Not Available
Karolinska Universitetssjukhuset, Solna
Stockholm, 113 41
SwedenSite Not Available
Stanford University
Palo Alto, California 94303
United StatesSite Not Available
University of California at San Francisco
San Francisco, California 94115
United StatesSite Not Available
University Of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Yale University School of Medicine ; Pulmonary & Critical Care
New Haven, Connecticut 06510
United StatesSite Not Available
University of Massachusetts Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
Washington University; Wash Uni. Sch. Of Med
Saint Louis, Missouri 63110
United StatesSite Not Available
Empire Neurology, PC
Latham, New York 12210
United StatesSite Not Available
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
New York, New York 63110
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390-0001
United StatesSite Not Available

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