Status:
COMPLETED
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI ...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Relapsing-remitting multiple sclerosis (MS)
- Ages 18-55 years inclusive
- For sexually active female and male participants of reproductive potential, use of reliable means of contraception
Exclusion
- Secondary or primary progressive multiple sclerosis at screening
- Incompatibility with MRI
- Contra-indications to or intolerance of oral or IV 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 IV 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 beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
- Systemic corticosteroid therapy within 4 weeks prior to randomization
Key Trial Info
Start Date :
July 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00676715
Start Date
July 17 2008
End Date
November 8 2023
Last Update
December 31 2024
Active Locations (84)
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1
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States, 85006
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley, California, United States, 94705
4
University of California San Francisco
San Francisco, California, United States, 94117