Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis



Status:Available
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 55
Updated:5/10/2017
Contact:Reference Study ID Number: ML29972 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

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.


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
We found this trial at
56
sites
Golden Valley, Minnesota 55422
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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5090 N 40th St # 250
Phoenix, Arizona 85018
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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701 White Pond Drive
Akron, Ohio 44320
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Aurora, Colorado 80045
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Boston, Massachusetts 02135
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6555 Coyle Avenue
Carmichael, California 95608
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Charlotte, North Carolina 28203
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Detroit, Michigan 48201
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Detroit, Michigan 48202
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Fairfield, Connecticut 06824
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Farmington Hills, Michigan 48334
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2121 East Harmony Road
Fort Collins, Colorado 80528
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Fort Wayne, Indiana 46805
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37934
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Louisville, Kentucky 40207
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1600 Northwest 10th Avenue
Miami, Florida 33136
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2301 North Lake Drive
Milwaukee, Wisconsin 53211
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Nashville, Tennessee 37205
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Newark, New Jersey 07103
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3900 West Coast Highway
Newport Beach, California 92663
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Northbrook, Illinois 60062
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Norwich, Connecticut 06360
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825 Northeast 13th Street
Oklahoma City, Oklahoma 73104
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orlando, Florida 32806
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Palo Alto, California 94304
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Pasadena, California 91105
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Patchogue, New York 11772
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97225
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Providence, Rhode Island 02905
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Raleigh, North Carolina 27607
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165 Wadsworth Drive
Richmond, Virginia 23236
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Saint Louis, Missouri 63110
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San Antonio, Texas 78258
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1500 Owens Street
San Francisco, California 94158
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Sunrise, Florida 33351
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Teaneck, New Jersey 07666
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Vero Beach, Florida 32960
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Willow Grove, Pennsylvania 19090
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