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View Clinical Trial (Medical Research Study)
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A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis - NCT00676715-48334 (Clinical Trial 220217)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy220217.aspx
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| City: |
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Farmington Hills |
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State:
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MI |
| Zip Code: |
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48334 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and
Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI
lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Ability to provide written informed consent and to be compliant with the schedule of
protocol assessments
- Relapsing-remitting MS
- Ages 18-55 years inclusive
- For sexually active female and male patients of reproductive potential, use of
reliable means of contraception
Exclusion Criteria:
- Secondary or primary progressive multiple sclerosis at screening
- Incompatibility with MRI
- Contra-indications to or intolerance of oral or i.v. corticosteroids
- Known presence of other neurologic disorders
- Pregnancy or lactation
- Lack of peripheral venous access
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies
- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic,
endocrine or gastrointestinal
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection or
any major episode of infection requiring hospitalization or treatment with i.v.
antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks
prior to screening
- History or known presence of recurrent or chronic infection
- 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)
- History of alcohol or drug abuse within 24 weeks prior to randomization
- History of or currently active primary or secondary immunodeficiency
- History of coagulation disorders
- Treatment with any investigational agent within 4 weeks of screening
- Receipt of a live vaccine within 6 weeks prior to randomization
- Incompatibility with Avonex use
- Previous treatment with rituximab
- Previous treatment with lymphocyte-depleting therapies except mitoxantrone
- Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
- Treatment with β interferons, glatiramer acetate, i.v. immunoglobulin,
plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
- Systemic corticosteroid therapy within 4 weeks prior to randomization |
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| Study is available at: |
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Michigan Institute for Neurological Disorders
Farmington Hills, MI 48334
United States
Primary Contact:
Sonda Rossman
Email: SondaLL@aol.com
Phone: 248-553-0010
Secondary Contact:
Genentech Trial Information Support Line
Phone: 888-662-6728 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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