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) |
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.
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
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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7000 Fannin St
Houston, Texas 77030
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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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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1600 Northwest 10th Avenue
Miami, Florida 33136
Miami, Florida 33136
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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825 Northeast 13th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1500 Owens Street
San Francisco, California 94158
San Francisco, California 94158
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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