Multiple Sclerosis Clinical Trial

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

Summary

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Absence of relapses for 30 days prior to the screening visit
For the dose escalation phase for participants pretreated with ocrelizumab (Group A):

treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)

For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab.
For female perticipants without reproductive potential:

Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).

Exclusion Criteria:

MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score <2.0 at screening.
Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following:
History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma)
History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy.
History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome)
Neuromyelitis optica
History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis).
History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT03972306

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 20 Locations for this study

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University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora Colorado, 80045, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa Florida, 33612, United States
The NeuroMedical Clinic of Central Louisiana
Alexandria Louisiana, 71301, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
John Hopkins University School of Medicine
Baltimore Maryland, 21287, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
Wayne State University; Department of Neurology
Detroit Michigan, 48201, United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso Michigan, 48867, United States
Washington Univ School of Med; Dept Neurology
Saint Louis Missouri, 63110, United States
Columbia University Medical Center
New York New York, 10032, United States
Cleveland Clinic Mellen Center; U10
Cleveland Ohio, 44195, United States
UC Health Neurology
Dayton Ohio, 45417, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Premier Neurology
Greenville South Carolina, 29605, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
University of Texas at Houston; Neurology
Houston Texas, 77030, United States
Swedish Neuroscience Institute; Multiple Sclerosis Center
Seattle Washington, 98122, United States
MultiCare Health System Institute for Research and Innovation
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT03972306

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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