A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Status: | Active, not recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/8/2019 |
Start Date: | March 2, 2011 |
End Date: | December 9, 2021 |
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
This randomized, parallel group, double-blind, placebo controlled study will evaluate the
efficacy and safety of ocrelizumab in participants with primary progressive multiple
sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or
placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label
Extension (OLE) treatment for participants in both groups who in the opinion of the
investigator could benefit from further or newly initiated ocrelizumab treatment. Unless
terminated early, all participants may continue their treatment with open-label ocrelizumab
until 31 December 2020.
efficacy and safety of ocrelizumab in participants with primary progressive multiple
sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or
placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label
Extension (OLE) treatment for participants in both groups who in the opinion of the
investigator could benefit from further or newly initiated ocrelizumab treatment. Unless
terminated early, all participants may continue their treatment with open-label ocrelizumab
until 31 December 2020.
Inclusion Criteria:
- Diagnosis of primary progressive multiple sclerosis (according to revised McDonald
criteria)
- EDSS at screening from 3 to 6.5 points
- Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than
(>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0
- Sexually active male and female participants of reproductive potential must use two
methods of contraception throughout the study treatment phase and for 48 weeks after
the last dose
Exclusion Criteria:
- History of relapsing remitting MS, secondary progressive, or progressive relapsing MS
at screening
- Inability to complete an MRI (contraindications for MRI)
- Known presence of other neurologic disorders
- Known active infection or history of or presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except for
basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the
cervix that have been excised and resolved)
- Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab,
atacicept, belimumab, or ofatumumab)
- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab,
anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone,
azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body
irradiation, or bone marrow transplantation
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study
We found this trial at
50
sites
825 Northeast 13th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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152 East Kinderton Way
Advance, North Carolina 27006
Advance, North Carolina 27006
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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2799 West Grand Boulevard
Detroit, Michigan 48202
Detroit, Michigan 48202
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7200 Cambridge Street
Houston, Texas 77030
Houston, Texas 77030
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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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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720 Southeast Washington Avenue
Minneapolis, Minnesota 55414
Minneapolis, Minnesota 55414
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77 Medford Avenue
Patchogue, New York 11772
Patchogue, New York 11772
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
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1 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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505 Parnassus Avenue
San Francisco, California 94143
San Francisco, California 94143
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Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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