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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)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocrelizumab
Ocrelizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • North Central Neurology Associates
  • Phoenix Neurological Associates Ltd
  • Barrow Neurological Institute
  • Territory Neurology and Research Institute
  • The Research Center of Southern California, LLC
  • Mercy Medical Group; MS Centre Nurse
  • Fullerton Neurology and Headache Center
  • Scripps Health
  • UCSF- Multiple Sclerosis Centre; Department of Neurology
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
  • IMMUNOe Research Centers
  • Colorado Neurological Institute
  • Advanced Neurology of Colorado, LLC
  • Associated Neurologists of Southern CT PC
  • KI Health Partners, LLC; New England Institute for Clinical Research
  • Neurology Associates PA
  • University of Miami Miller School of Medicine; Clinical Reseach Building
  • Neurostudies Inc
  • Infinity Clinical Research, LLC
  • Axiom Clinical Research of Florida
  • University of South Florida - Bradenton
  • Ms Center Of Atlanta
  • University of Chicago Hospital
  • Consultants in Neurology Ltd
  • American Health Network Institute, LLC
  • Josephson Wallack Munshower Neurology PC
  • University of Kansas Medical Center; Division of Nuclear Medicine
  • Lahey Clinic Med Ctr
  • Associates in Neurology PSC
  • Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services
  • Ochsner Clinic Foundation
  • University of Maryland Medical Center; Department of Neurology
  • John Hopkins University School of Medicine
  • Massachusetts General Hospital
  • Beth Israel Deaconess Med Ctr; Neurology/MS Center
  • Dragonfly Research, LLC
  • UMASS Memorial Medical Center
  • Wayne State University; Department of Neurology
  • Minneapolis Clinic of Neurology
  • Washington University School of Medicine; Department of Neurology
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • Rutgers New Jersey Medical School
  • Holy Name Hospital; Institute For Clinical Research
  • Jacobs Neurological Institute
  • The MS Center of Northeastern New York
  • Columbia University Medical Center
  • South Shore Neurologic Associates P.C.
  • Island Neurological Associates, P.C.
  • Raleigh Neurology Associates
  • UC Health Clinical Trials Office
  • Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
  • The Ohio State University Wexner Medical Center; Department of Neurology
  • Neurology Specialists, Inc
  • Neurology and Neuroscience Assoc., Inc.
  • Oklahoma Medical Research Foundation
  • Providence Multiple Sclerosis Center
  • Allegheny Neurological Associates
  • Neurology Clinic PC
  • Hope Neurology
  • Uni of Texas Health Science Center At Houston
  • Bhupesh Dihenia M.D. P.A.
  • Central Texas Neurology Consultants
  • Neurology Center of San Antonio
  • Rocky Mountain MS Clinic
  • Swedish Neuroscience Institute
  • MultiCare Health System Institute for Research and Innovation
  • Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
  • University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,
  • Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy
  • Horizon Health Network - Multiple Sclerosis Clinic
  • Dalhousie Multiple Sclerosis Research Unit
  • Hamilton General Hospital
  • The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
  • St. Michael's Hospital MS Clinic, MS Research Centre
  • Clinique NeuroOutaouais
  • Recherche Sepmus, Inc.
  • Hopital Hotel Dieu de Levis
  • Chum Campus Notre Dame
  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric
  • MS Clinic Mauricie Bois Francs
  • CHU De Quebec Universite Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ocrelizumab

Ocrelizumab (substudy)

Arm Description

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).

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)

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-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 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time to Protocol-Defined Event
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1)
Time to Onset of First Protocol-Defined Relapse
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI
Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.
Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI
Baseline data is represented as mean; post-Baseline date are represented as mean changes.
Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Full Information

First Posted
December 18, 2015
Last Updated
May 8, 2020
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02637856
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2016 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Participants who complete their Week 72 ocrelizumab infusion and do not experience any serious infusion related reaction (IRR) throughout the main study will be eligible to enroll in an optional, open-label, non-randomized substudy to MN30035 and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately 100 patients from MN30035 main study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
608 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Ocrelizumab (substudy)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Description
Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Primary Outcome Measure Information:
Title
Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period
Description
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.
Time Frame
Baseline up to Week 96
Title
Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy
Description
Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion
Time Frame
Week 96 to Week 100
Secondary Outcome Measure Information:
Title
Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period
Description
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time Frame
Baseline up to Weeks 24 and 48
Title
Time to Protocol-Defined Event
Description
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time Frame
Baseline up to Week 96
Title
Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period
Description
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1)
Time Frame
Baseline up to Week 96
Title
Time to Onset of First Protocol-Defined Relapse
Description
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
Time Frame
Baseline up to Week 96
Title
Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI
Time Frame
Baseline up to Week 96
Title
Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI
Time Frame
Baseline up to Week 96
Title
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score
Time Frame
Baseline up to Week 96
Title
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Description
The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.
Time Frame
Weeks 24, 48, and 96
Title
Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI
Description
Baseline data is represented as mean; post-Baseline date are represented as mean changes.
Time Frame
Baseline, Weeks 24, 48, and 96
Title
Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI
Time Frame
Weeks 24, 48, and 96
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline up to 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Phoenix Neurological Associates Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Territory Neurology and Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
The Research Center of Southern California, LLC
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Mercy Medical Group; MS Centre Nurse
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Fullerton Neurology and Headache Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSF- Multiple Sclerosis Centre; Department of Neurology
City
San Francisco
State/Province
California
ZIP/Postal Code
CA94158
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Advanced Neurology of Colorado, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Associated Neurologists of Southern CT PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
KI Health Partners, LLC; New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Neurology Associates PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami Miller School of Medicine; Clinical Reseach Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurostudies Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida - Bradenton
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Ms Center Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Consultants in Neurology Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Josephson Wallack Munshower Neurology PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
University of Kansas Medical Center; Division of Nuclear Medicine
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Lahey Clinic Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
02421
Country
United States
Facility Name
Associates in Neurology PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center; Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr; Neurology/MS Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dragonfly Research, LLC
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University; Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Washington University School of Medicine; Department of Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Holy Name Hospital; Institute For Clinical Research
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Jacobs Neurological Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
The MS Center of Northeastern New York
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
South Shore Neurologic Associates P.C.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Island Neurological Associates, P.C.
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
UC Health Clinical Trials Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center; Department of Neurology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology Specialists, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Neurology and Neuroscience Assoc., Inc.
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Multiple Sclerosis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Hope Neurology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Uni of Texas Health Science Center At Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Bhupesh Dihenia M.D. P.A.
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Rocky Mountain MS Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6C 2G3
Country
Canada
Facility Name
Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Horizon Health Network - Multiple Sclerosis Clinic
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dalhousie Multiple Sclerosis Research Unit
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
St. Michael's Hospital MS Clinic, MS Research Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique NeuroOutaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Recherche Sepmus, Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hopital Hotel Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Chum Campus Notre Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
MS Clinic Mauricie Bois Francs
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CHU De Quebec Universite Laval
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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)

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