A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.

Key facts

Study ID: NCT02637856
Run by: Genentech, Inc.
People needed: 608
Starts: 2016-02-11
Expected to finish: 2019-05-03
Last updated by the study team: 2020-05-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
Disease duration from first symptom of less than or equal to (</=) 12 years
Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response
Suboptimal response while the participant was on his/her last adequately used DMT for >/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening

You may not qualify if…

History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
Contraindications for MRI
Known presence of other neurological disorders that may mimic multiple sclerosis
Pregnancy or lactation, or intention to become pregnant during the study
Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History of or currently active primary or secondary immunodeficiency
Lack of peripheral venous access
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 such as human immunodeficiency virus (HIV), syphilis, or tuberculosis
History of progressive multifocal leukoencephalopathy
Contraindications to or intolerance of oral or IV corticosteroids
Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN)
Treatment with alemtuzumab (Lemtrada®)
Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate
Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment
Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to screening
Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)

Where it is running

Phoenix Neurological Associates Ltd — Phoenix, Arizona, United States
Barrow Neurological Institute — Phoenix, Arizona, United States
Territory Neurology and Research Institute — Tucson, Arizona, United States
The Research Center of Southern California, LLC — Carlsbad, California, United States
Mercy Medical Group; MS Centre Nurse — Carmichael, California, United States
Fullerton Neurology and Headache Center — Fullerton, California, United States
Scripps Health — La Jolla, California, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology — San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C. — Basalt, Colorado, United States
IMMUNOe Research Centers — Centennial, Colorado, United States
Colorado Neurological Institute — Englewood, Colorado, United States
Advanced Neurology of Colorado, LLC — Fort Collins, Colorado, United States
Associated Neurologists of Southern CT PC — Fairfield, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical Research — Stamford, Connecticut, United States
Neurology Associates PA — Maitland, Florida, United States
University of Miami Miller School of Medicine; Clinical Reseach Building — Miami, Florida, United States
Neurostudies Inc — Port Charlotte, Florida, United States
Infinity Clinical Research, LLC — Sunrise, Florida, United States
Axiom Clinical Research of Florida — Tampa, Florida, United States
University of South Florida - Bradenton — Tampa, Florida, United States
Ms Center Of Atlanta — Atlanta, Georgia, United States
University of Chicago Hospital — Chicago, Illinois, United States
Consultants in Neurology Ltd — Northbrook, Illinois, United States
North Central Neurology Associates — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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