A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Status: | Active, not recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/21/2019 |
Start Date: | February 11, 2016 |
End Date: | December 30, 2019 |
An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who
have had a suboptimal response to an adequate course of DMT. Participants will receive
ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg
total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up
to 96 weeks). Anticipated time on study treatment is 96 weeks.
have had a suboptimal response to an adequate course of DMT. Participants will receive
ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg
total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up
to 96 weeks). Anticipated time on study treatment is 96 weeks.
Inclusion Criteria:
- Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised
2010 McDonald criteria
- Disease duration from first symptom of less than or equal to (=) 12 years
- Treated with an adequate course of treatment with no more than three prior DMT
regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the
most recent adequately used DMT was due to suboptimal response
- Suboptimal response while the participant was on his/her last adequately used DMT for
>/=6 months (defined by having one of the following qualifying events despite being on
a stable dose of the same DMT for at least 6 months: one or more clinically reported
relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2
lesions on MRI); these qualifying events must have occurred while on the last
adequately used DMT. In participants receiving stable doses of the same approved DMT
for more than a year, the event must have occurred within the last 12 months of
treatment with this DMT from the date of screening
Exclusion Criteria:
- History of primary progressive multiple sclerosis (PPMS), progressive relapsing
multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
- Contraindications for MRI
- Known presence of other neurological disorders that may mimic multiple sclerosis
- Pregnancy or lactation, or intention to become pregnant during the study
- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study
- History of 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
- Active infection, or history of or known presence of recurrent or chronic infection
such as human immunodeficiency virus (HIV), syphilis, or tuberculosis
- History of progressive multifocal leukoencephalopathy
- Contraindications to or intolerance of oral or IV corticosteroids
- Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in
participants whose lymphocyte count is below the lower limit of normal (LLN)
- Treatment with alemtuzumab (Lemtrada®)
- Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate
mofetil, cyclosporine, or methotrexate
- Previous treatment with natalizumab within 12 months prior to screening unless failure
was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously
treated with natalizumab will be eligible for this study only if duration of treatment
with natalizumab was less than (<) 1 year and natalizumab was not used in the 12
months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive
or negative) and titer (both assessed within the year of screening) must be documented
prior to enrollment
- Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to
screening
- Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept,
belimumab, or ofatumumab)
- Treatment with a drug that is experimental (Exception: treatment with an experimental
drug that was subsequently approved in the participant's country is allowed)
We found this trial at
75
sites
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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350 Market Street
Basalt, Colorado 81621
Basalt, Colorado 81621
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1403 29 Street Northwest
Calgary, Alberta T2N 2T9
Calgary, Alberta T2N 2T9
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2010 East 90th Street
Cleveland, Ohio 44195
Cleveland, Ohio 44195
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
Kansas City, Kansas 66160
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
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Louisville, Kentucky 40207
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1600 Northwest 10th Avenue
Miami, Florida 33136
Miami, Florida 33136
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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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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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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