The primary objective of this expanded access program is to provide ocrelizumab astreatment for eligible participants with primary progressive multiple sclerosis (PPMS)before it is commercially available in the United States (U.S.) for the indication ofPPMS.
Not Provided
Drug: Ocrelizumab
Participants will receive 600 mg ocrelizumab as two 300 mg infusions separated by 14
days, every 24 weeks.
Other Name: RO4964913
Inclusion Criteria:
- Age 18 to 55 years (inclusive)
- Diagnosis of PPMS in accordance with the revised 2010 McDonald criteria and the
presence or documented history of cerebrospinal fluid oligoclonal bands by
isoelectric focusing or elevated immunoglobulin G (IgG) index
- Expanded Disability Status Score (EDSS) of 2.0 to 6.5 points at screening
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of less than (<)1 percent (%) per year during the treatment period and for at least
24 weeks after the last dose of study treatment or until their B-cells have
repleted, whichever is longer
Exclusion Criteria:
- History of relapsing-remitting multiple sclerosis (RRMS), progressive relapsing
multiple sclerosis (PRMS) or secondary progressive multiple sclerosis (SPMS) at
screening
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies
- History or known presence of recurrent or chronic infection
- History of recurrent aspiration pneumonia requiring antibiotic therapy
- History of cancer, including solid tumors and hematological malignancies (except
basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of
the cervix of the uterus that have been excised and resolved with documented clean
margins on pathology)
- History of or currently active primary or secondary immunodeficiency
- History of coagulation disorders because ocrelizumab is administered via infusion
- Known presence or history of other neurologic disorders
- Significant, uncontrolled disease, such as cardiovascular (including cardiac
arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal,
hepatic, endocrine, gastrointestinal, or any other significant disease
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection, or other infection
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the expanded access
program (EAP)
- Contraindications for or intolerance to oral or IV corticosteroids, including IV
methylprednisolone
- Treatment with therapies approved for relapsing forms of Multiple Sclerosis (MS),
including: Beta interferons, glatiramer acetate, fingolimod (Gilenya®),
teriflunomide (Aubagio®), dimethyl fumarate (Tecfidera®), IV immunoglobulin,
plasmapheresis, or other immunomodulatory therapies within 12 weeks prior to
enrollment (Participants should not be excluded from the EAP due to previous
treatment with rituximab)
- Participants who have received fingolimod (Gilenya®) or dimethyl fumarate
(Tecfidera®) if their lymphocyte count is not within normal values
- Previous treatment with natalizumab (Tysabri®) within 6 months of screening
(Participants are not eligible for the EAP if they have been treated with
natalizumab (Tysabri) for more than 1 year)
- Any previous treatment with alemtuzumab (Lemtrada®)
- Any previous or current treatment with any experimental procedure for MS
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States
Territory Neurology and Research Institute
Tucson, Arizona, United States
Mercy Medical Group; MS Centre Nurse
Carmichael, California, United States
Scripps Clinic
La Jolla, California, United States
MS Center of Southern California
Newport Beach, California, United States
Stanford University
Palo Alto, California, United States
Neuro-Therapeutics Inc.
Pasadena, California, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, United States
Neurology Associates
Norwich, Connecticut, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
Neurological Services of Orlando
Orlando, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
University of South Florida
Tampa, Florida, United States
MS Center of Vero Beach
Vero Beach, Florida, United States
Consultants in Neurology Ltd
Northbrook, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Neurology Services
Louisville, Kentucky, United States
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Wayne State Uni /Detroit Medical Center
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Washington University
Saint Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
South Shore Neurologic Associates P.C.
Patchogue, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio, United States
Neurology and Neuroscience Assoc., Inc.
Westerville, Ohio, United States
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, United States
Providence Multiple Sclerosis Center
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
The Neurology Foundation, Inc.
Providence, Rhode Island, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Advanced Neurosciences Institute
Nashville, Tennessee, United States
University Of Texas Health Science Center Houston
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Neurological Associates Inc; Clinical Research
Richmond, Virginia, United States
Swedish Neuroscience Institute; Multiple Sclerosis Center
Seattle, Washington, United States
Multicare Neuroscience Center of Washington
Tacoma, Washington, United States
Columbia St. Mary's Hospital System
Milwaukee, Wisconsin, United States
Clinical Trials, Study Director
Hoffmann-La Roche