Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/27/2019 |
Start Date: | April 4, 2017 |
End Date: | February 22, 2024 |
Contact: | Reference Study ID: MA30143 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, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates
effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will
consist of an open-label treatment period of 192 weeks and follow-up period of at least 48
weeks.
effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will
consist of an open-label treatment period of 192 weeks and follow-up period of at least 48
weeks.
Inclusion Criteria:
- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first documented clinical attack consistent
with MS disease of less than or equal to (=) 3 years
- Within the last 12 months one or more clinically reported relapse(s) or one or more
signs of MRI activity
- EDSS of 0.0 to 3.5 inclusive, at screening
- An agreement to use an acceptable birth control method for women of childbearing
potential, during the treatment period and for at least 6 months after the last dose
of study drug
Exclusion Criteria:
- Secondary progressive multiple sclerosis or history of primary progressive or
progressive relapsing MS
- Inability to complete an MRI
- Known presence of other neurological disorders
Exclusions Related to General Health:
- Pregnancy or lactation
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study
- History 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
- Significant or uncontrolled somatic disease or any other significant disease that may
preclude participant from participating in the study
- Congestive heart failure (New York Heart Association III or IV functional severity)
- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
(excluding fungal infection of nail beds) or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or
oral antibiotics 2 weeks prior to screening
- History of malignancy, major opportunistic infections, alcohol or drug abuse,
recurrent or chronic infection, and/or coagulation disorders
Exclusions Related to Medications:
- Received any prior approved disease modifying treatment (DMT) with a label for MS, for
example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab,
fingolimod, teiflunomide and dimethylfumarate
- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the
baseline visit
- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab,
atacicept, belimumab, or ofatumumab)
- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic
therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine,
methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone
marrow transplantation)
- Treatment with investigational DMT
- Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to
screening
We found this trial at
31
sites
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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2010 East 90th Street
Cleveland, Ohio 44195
Cleveland, Ohio 44195
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
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3237 South 16th Street
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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