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
2010 East 90th Street
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Click here to add this to my saved trials
Click here to add this to my saved trials
350 Market Street
Basalt, Colorado 81621
Basalt, Colorado 81621
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1403 29 Street Northwest
Calgary, Alberta T2N 2T9
Calgary, Alberta T2N 2T9
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
3901 Rainbow Boulevard
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
888 West Bonneville Avenue
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Louisville, Kentucky 40207
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1600 Northwest 10th Avenue
Miami, Florida 33136
Miami, Florida 33136
Click here to add this to my saved trials
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1500 Owens Street
San Francisco, California 94158
San Francisco, California 94158
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials