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 study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study 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

  • Advanced Neurology of Colorado, LLC

    2121 E Harmony Rd80528Fort CollinsUnited States
  • Allegheny Neurological Associates

    420 E North Ave15212PittsburghUnited States
  • American Health Network Institute, LLC

    8607 E US Hwy 3646123AvonUnited States
  • Associated Neurologists of Southern CT PC

    75 Kings Hwy Cutoff06824FairfieldUnited States
  • Associates in Neurology PSC

    1021 Majestic Dr40513LexingtonUnited States
  • Axiom Clinical Research of Florida

    2919 W Swann Ave33609TampaUnited States
  • Barrow Neurological Institute

    350 W Thomas Rd85013PhoenixUnited States
  • Beth Israel Deaconess Med Ctr; Neurology/MS Center

    330 Brookline Ave02215BostonUnited States
  • Bhupesh Dihenia M.D. P.A.

    3815 23rd St79410LubbockUnited States
  • Central Texas Neurology Consultants

    16040 Park Valley Dr78681Round RockUnited States
  • CHU De Quebec Universite Laval

    11 Côte du PalaisG1R 2J6QuébecCanada
  • Chum Campus Notre Dame

    1051 Rue SanguinetH2X 3E4MontréalCanada
  • Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

    10201 Carnegie Ave44106ClevelandUnited States
  • Cleveland Clinic Lou Ruvo; Center for Brain Research

    888 W Bonneville Ave89106Las VegasUnited States
  • Clinique NeuroOutaouais

    209 Rue GamelinJ8Y 1W2GatineauCanada
  • Colorado Neurological Institute

    750 W Hampden Ave80110EnglewoodUnited States
  • Columbia University Medical Center

    622 W 168th St10032New YorkUnited States
  • Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services

    3991 Dutchmans Ln40207LouisvilleUnited States
  • Consultants in Neurology Ltd

    1535 Lake Cook Rd60062NorthbrookUnited States
  • Dalhousie Multiple Sclerosis Research Unit

    1341 Summer StB3H 4K4HalifaxCanada
  • Dragonfly Research, LLC

    110 Cedar St02481WellesleyUnited States
  • Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

    1403 29 St NWT2N 4J8CalgaryCanada
  • Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy

    3935 Kincaid StV5G 2X6BurnabyCanada
  • Fullerton Neurology and Headache Center

    100 Laguna Rd92835FullertonUnited States
  • Hamilton General Hospital

    237 Barton St EL8L 2X2HamiltonCanada
  • Holy Name Hospital; Institute For Clinical Research

    718 Teaneck Rd07666TeaneckUnited States
  • Hope Neurology

    2060 Lakeside Centre Wy37922KnoxvilleUnited States
  • Hopital Hotel Dieu de Levis

    143 Rue WolfeG6V 3Z1LévisCanada
  • Horizon Health Network - Multiple Sclerosis Clinic

    400 University AveE2L 4L2Saint JohnCanada
  • IMMUNOe Research Centers

    6801 S Yosemite St80112CentennialUnited States
  • Infinity Clinical Research, LLC

    3540 NW 88th Ave33351SunriseUnited States
  • Island Neurological Associates, P.C.

    824 Old Country Rd11803PlainviewUnited States
  • Jacobs Neurological Institute

    3 Gates Cir14209BuffaloUnited States
  • John Hopkins University School of Medicine

    733 N Broadway21205BaltimoreUnited States
  • Josephson Wallack Munshower Neurology PC

    7250 Clearvista Dr46256IndianapolisUnited States
  • KI Health Partners, LLC; New England Institute for Clinical Research

    30 Buxton Farm Rd06905StamfordUnited States
  • Lahey Clinic Med Ctr

    16 Hayden Ave02421LexingtonUnited States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    1124 W Carson St90502TorranceUnited States
  • Massachusetts General Hospital

    55 Fruit St02114BostonUnited States
  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric

    3801 Rue UniversityH3A 2B4MontréalCanada
  • Mercy Medical Group; MS Centre Nurse

    6555 Coyle Ave95608CarmichaelUnited States
  • Minneapolis Clinic of Neurology

    4225 Golden Valley Rd55422MinneapolisUnited States
  • Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

    350 Market St81621BasaltUnited States
  • Ms Center Of Atlanta

    3200 Downwood Cir NW30327AtlantaUnited States
  • MS Clinic Mauricie Bois Francs

    2515 Rue RoyaleG9A 4L7Trois-RivièresCanada
  • MultiCare Health System Institute for Research and Innovation

    98405TacomaUnited States
  • Neurology and Neuroscience Assoc., Inc.

    450 Alkyre Run Dr43082WestervilleUnited States
  • Neurology Associates PA

    301 N Maitland Ave32751MaitlandUnited States
  • Neurology Center of San Antonio

    1314 E Sonterra Blvd78258San AntonioUnited States
  • Neurology Clinic PC

    8000 Centerview Pkwy38018MemphisUnited States
  • Neurology Specialists, Inc

    1 Elizabeth Pl45417DaytonUnited States
  • Neurostudies Inc

    4161 Tamiami Trail33952Port CharlotteUnited States
  • North Central Neurology Associates

    1809 Kress St35058CullmanUnited States
  • Ochsner Clinic Foundation

    101 W Robert E Lee Blvd70124New OrleansUnited States
  • Oklahoma Medical Research Foundation

    825 NE 13th St73104Oklahoma CityUnited States
  • Phoenix Neurological Associates Ltd

    5090 N 40th St85018PhoenixUnited States
  • Providence Multiple Sclerosis Center

    9135 SW Barnes Rd97225PortlandUnited States
  • Raleigh Neurology Associates

    1520 Sunday Dr27607RaleighUnited States
  • Recherche Sepmus, Inc.

    4896 Bd TaschereauJ4V 2J2LongueuilCanada
  • Rocky Mountain MS Clinic

    370 9th Ave84103Salt Lake CityUnited States
  • Rutgers New Jersey Medical School

    185 W S Orange Ave07103NewarkUnited States
  • Scripps Health

    9888 Genesee Ave92037San DiegoUnited States
  • South Shore Neurologic Associates P.C.

    77 Medford Ave11772PatchogueUnited States
  • St. Michael's Hospital MS Clinic, MS Research Centre

    30 Bond StM5B 1W8TorontoCanada
  • Swedish Neuroscience Institute

    1600 E Jefferson St98122SeattleUnited States
  • Territory Neurology and Research Institute

    1631 W Ina Rd85704TucsonUnited States
  • The MS Center of Northeastern New York

    1182 Troy Schenectady Rd12110LathamUnited States
  • The Ohio State University Wexner Medical Center; Department of Neurology

    456 W 10th Ave43210ColumbusUnited States
  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

    501 Smyth RdK1H 8L6OttawaCanada
  • The Research Center of Southern California, LLC

    2231 Rutherford Rd92008CarlsbadUnited States
  • UC Health Clinical Trials Office

    3130 Highland Ave45219CincinnatiUnited States
  • UCSF- Multiple Sclerosis Centre; Department of Neurology

    1651 4th St94158San FranciscoUnited States
  • UMASS Memorial Medical Center

    55 N Lake Ave01655WorcesterUnited States
  • Uni of Texas Health Science Center At Houston

    6410 Fannin St77030HoustonUnited States
  • University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,

    8440 112 St NWT6G 2B7EdmontonCanada
  • University of Chicago Hospital

    5841 S Maryland Ave60637ChicagoUnited States
  • University of Kansas Medical Center; Division of Nuclear Medicine

    3901 Rainbow Blvd66160Kansas CityUnited States
  • University of Maryland Medical Center; Department of Neurology

    110 S Paca St21201BaltimoreUnited States
  • University of Miami Miller School of Medicine; Clinical Reseach Building

    1120 NW 14th St33136MiamiUnited States
  • University of South Florida - Bradenton

    4202 E Fowler Ave33620TampaUnited States
  • Washington University School of Medicine; Department of Neurology

    660 S Euclid Ave63108St. LouisUnited States
  • Wayne State University; Department of Neurology

    4201 St Antoine48201DetroitUnited States
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study 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)

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