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)

NCT02637856 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MN30035
• Study Type: interventional
• Target: 608
• Locations: 2 countries
• Sites: 82

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period

  Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.

  Baseline up to Week 96

• Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy

  Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion

  Week 96 to Week 100

Secondary Outcomes (11)

• Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period

  Baseline up to Weeks 24 and 48

• Time to Protocol-Defined Event

  Baseline up to Week 96

• Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period

  Baseline up to Week 96

• Time to Onset of First Protocol-Defined Relapse

  Baseline up to Week 96

• Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI

  Baseline up to Week 96

Study Arms (2)

Ocrelizumab

EXPERIMENTAL

Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).

Drug: Ocrelizumab

Ocrelizumab (substudy)

EXPERIMENTAL

Participants with no serious IRR throughout the main study will be eligible to enroll in an optional substudy and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab will be administered IV as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).

Also known as: RO4964913

Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (82)

North Central Neurology Associates

Cullman, Alabama, 35058, United States

Location

Phoenix Neurological Associates Ltd

Phoenix, Arizona, 85006, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Territory Neurology and Research Institute

Tucson, Arizona, 85704, United States

Location

The Research Center of Southern California, LLC

Carlsbad, California, 92011, United States

Location

Mercy Medical Group; MS Centre Nurse

Carmichael, California, 95608, United States

Location

Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

UCSF- Multiple Sclerosis Centre; Department of Neurology

San Francisco, California, CA94158, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

Basalt, Colorado, 81621, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, 80528, United States

Location

Associated Neurologists of Southern CT PC

Fairfield, Connecticut, 06824, United States

Location

KI Health Partners, LLC; New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

University of Miami Miller School of Medicine; Clinical Reseach Building

Miami, Florida, 33136, United States

Location

Neurostudies Inc

Port Charlotte, Florida, 33952, United States

Location

Infinity Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

University of South Florida - Bradenton

Tampa, Florida, 33612, United States

Location

Ms Center Of Atlanta

Atlanta, Georgia, 30327, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Consultants in Neurology Ltd

Northbrook, Illinois, 60062, United States

Location

American Health Network Institute, LLC

Avon, Indiana, 46123, United States

Location

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46256, United States

Location

University of Kansas Medical Center; Division of Nuclear Medicine

Kansas City, Kansas, 66160, United States

Location

Lahey Clinic Med Ctr

Lexington, Kentucky, 02421, United States

Location

Associates in Neurology PSC

Lexington, Kentucky, 40513, United States

Location

Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services

Louisville, Kentucky, 40207, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland Medical Center; Department of Neurology

Baltimore, Maryland, 21201, United States

Location

John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med Ctr; Neurology/MS Center

Boston, Massachusetts, 02215, United States

Location

Dragonfly Research, LLC

Wellesley, Massachusetts, 02481, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Wayne State University; Department of Neurology

Detroit, Michigan, 48201, United States

Location

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

Washington University School of Medicine; Department of Neurology

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic Lou Ruvo; Center for Brain Research

Las Vegas, Nevada, 89106, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Holy Name Hospital; Institute For Clinical Research

Teaneck, New Jersey, 07666, United States

Location

Jacobs Neurological Institute

Buffalo, New York, 14203, United States

Location

The MS Center of Northeastern New York

Latham, New York, 12110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

South Shore Neurologic Associates P.C.

Patchogue, New York, 11772, United States

Location

Island Neurological Associates, P.C.

Plainview, New York, 11803, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607-6520, United States

Location

UC Health Clinical Trials Office

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center; Department of Neurology

Columbus, Ohio, 43210, United States

Location

Neurology Specialists, Inc

Dayton, Ohio, 45417, United States

Location

Neurology and Neuroscience Assoc., Inc.

Westerville, Ohio, 43081, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Multiple Sclerosis Center

Portland, Oregon, 97225, United States

Location

Allegheny Neurological Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Neurology Clinic PC

Cordova, Tennessee, 38018, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

Uni of Texas Health Science Center At Houston

Houston, Texas, 77030, United States

Location

Bhupesh Dihenia M.D. P.A.

Lubbock, Texas, 79410, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Neurology Center of San Antonio

San Antonio, Texas, 78212, United States

Location

Rocky Mountain MS Clinic

Salt Lake City, Utah, 84103, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,

Edmonton, Alberta, T6C 2G3, Canada

Location

Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy

Burnaby, British Columbia, V5G 2X6, Canada

Location

Horizon Health Network - Multiple Sclerosis Clinic

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dalhousie Multiple Sclerosis Research Unit

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Michael's Hospital MS Clinic, MS Research Centre

Toronto, Ontario, Canada

Location

Clinique NeuroOutaouais

Gatineau, Quebec, J8Y 1W2, Canada

Location

Recherche Sepmus, Inc.

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Hopital Hotel Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Chum Campus Notre Dame

Montreal, Quebec, H2X 0A9, Canada

Location

McGill University; Montreal Neurological Institute; Neurological and Psychiatric

Montreal, Quebec, H3A 2B4, Canada

Location

MS Clinic Mauricie Bois Francs

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

CHU De Quebec Universite Laval

Québec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 22, 2015
• Study Start: February 11, 2016
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: May 26, 2020
• Results First Posted: May 26, 2020

Record last verified: 2020-05

Locations

US (67); CA (15)