Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02807285
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
The primary objective of this expanded access program is to provide ocrelizumab as treatment for eligible participants with primary progressive multiple sclerosis (PPMS) before it is commercially available in the United States (U.S.) for the indication of PPMS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Steward St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
University Of Texas Health Science Center Houston
🇺🇸Houston, Texas, United States
The Ohio State University Wexner Medical Center; Department of Neurology
🇺🇸Columbus, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology
🇺🇸San Francisco, California, United States
Neurological Associates Inc; Clinical Research
🇺🇸Richmond, Virginia, United States
Territory Neurology and Research Institute
🇺🇸Tucson, Arizona, United States
Phoenix Neurological Associates Ltd
🇺🇸Phoenix, 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
University Of Colorado
🇺🇸Aurora, Colorado, United States
Advanced Neurology of Colorado, LLC
🇺🇸Fort Collins, Colorado, 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
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
Norton Neurology Services
🇺🇸Louisville, Kentucky, 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
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
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Neurology and Neuroscience Assoc., Inc.
🇺🇸Westerville, Ohio, United States
Providence Multiple Sclerosis Center
🇺🇸Portland, Oregon, United States
Oklahoma Medical Research Foundation; MS Center of Excellence
🇺🇸Oklahoma City, Oklahoma, 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
Central Texas Neurology Consultants
🇺🇸Round Rock, Texas, United States
Neurology Center of San Antonio
🇺🇸San Antonio, Texas, 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
University of Vermont
🇺🇸Burlington, Vermont, United States
Advanced Neurosciences Institute
🇺🇸Nashville, Tennessee, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Neurology Associates
🇺🇸Norwich, Connecticut, United States
Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Associated Neurologists of Southern CT PC
🇺🇸Fairfield, Connecticut, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States