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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)
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Completed
This trial runs in
Cities
- Atlanta
- Avon
- Baltimore
- Basalt
- Boston
- Buffalo
- Burnaby
- Calgary
- Carlsbad
- Carmichael
- Centennial
- Chicago
- Cincinnati
- Cleveland
- Columbus
- Cullman
- Dayton
- Detroit
- Edmonton
- Englewood
- Fairfield
- Fort Collins
- Fullerton
- Gatineau
- Halifax
- Hamilton
- Houston
- Indianapolis
- Kansas City
- Knoxville
- Las Vegas
- Latham
- Lexington
- Longueuil
- Louisville
- Lubbock
- Lévis
- Maitland
- Memphis
- Miami
- Minneapolis
- Montréal
- New Orleans
- New York
- Newark
- Northbrook
- Oklahoma City
- Ottawa
- Patchogue
- Phoenix
- Pittsburgh
- Plainview
- Port Charlotte
- Portland
- Québec
- Raleigh
- Round Rock
- Saint John
- Salt Lake City
- San Antonio
- San Diego
- San Francisco
- Seattle
- St. Louis
- Stamford
- Sunrise
- Tacoma
- Tampa
- Teaneck
- Toronto
- Torrance
- Trois-Rivières
- Tucson
- Wellesley
- Westerville
- Worcester
Trial Identifier:
NCT02637856 MN30035
Trial Summary
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.
Genentech, Inc.
Sponsor
Phase 3
Phase
NCT02637856,MN30035
Trial Identifier
Ocrelizumab
Treatments
Multiple Sclerosis, Relapsing-Remitting
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
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)
For the latest version of this information please go to www.forpatients.roche.com