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Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

Primary Purpose

Relapsing Multiple Sclerorsis, Multiple Sclerosis, Primary Progressive

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

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerorsis

Eligibility Criteria

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

Inclusion Criteria:

General Inclusion Criteria:

  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer

Inclusion Criteria Specific to RMS Participants:

  • Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
  • Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening
  • Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening
  • Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).
  • At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment

Inclusion Criteria Specific to RMS Cohort Arm 4 Participants:

  • Must meet inclusion criteria for the RMS cohort
  • Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4)
  • Must be willing to remain on the same dose and regimen of current standard of care, or no treatment if treatment-naïve, for 12 weeks after study enrollment The treating and/or study physician must agree that the participant is eligible to remain on the same dose and regimen of their current standard of care at Screening, or to receive no treatment if the participant is treatment-naïve, for 12 weeks after study enrollment

Inclusion Criteria Specific to PPMS Participants:

  • Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria
  • EDSS score of 3.0 - 6.5 points, inclusive, at Screening
  • Disease duration from the onset of multiple sclerosis symptoms <10 years in participants with an EDSS at Screening less than or equal to (</=) 5.0
  • Documented history of either elevated immunoglobulin G (IgG) Index or one or more IgG oligoclonal bands (OCBs) detected by isoelectric focusing

Exclusion Criteria:

  • Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year
  • History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis)
  • History of recurrent aspiration pneumonia requiring antibiotic therapy
  • 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 with documented clean margins on pathology)
  • History of or currently active primary or secondary immunodeficiency
  • History of coagulation disorders
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of alcohol or other drug abuse within 24 weeks prior to enrollment
  • Known presence or history of other neurologic disorders Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal, or any other significant disease
  • Congestive heart failure (according to New York Heart Association III or IV functional severity)
  • Known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Contraindications or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
  • Contraindication for LP
  • Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment
  • Receipt of a live vaccine within 6 weeks prior to enrollment
  • Systemic corticosteroid therapy within 4 weeks prior to Baseline
  • Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for multiple sclerosis (such as treatment for chronic cerebrospinal venous insufficiency)
  • Certain laboratory abnormalities or findings at Screening
  • Inability to complete an MRI
  • Lack of peripheral venous access
  • Pregnant or lactating, or intending to become pregnant during the study

Exclusion Criteria Specific to RMS Participants:

  • Diagnosis of PPMS or secondary progressive multiple sclerosis without relapses

Sites / Locations

  • Stanford University
  • University of California at San Francisco
  • University Of Colorado
  • Yale University School of Medicine ; Pulmonary & Critical Care
  • University of Massachusetts Medical School
  • Washington University; Wash Uni. Sch. Of Med
  • Empire Neurology, PC
  • Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
  • University of North Carolina at Chapel Hill
  • Ohio State University
  • Oklahoma Medical Research Foundation; MS Center of Excellence
  • University of Texas Southwestern Medical Center
  • University of British Columbia Hospital Site; Djavad Mowafaghian Centre for Brain Health
  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Universitätsmedizin Göttingen Georg-August-Universität
  • Karolinska Universitetssjukhuset, Solna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

RMS Cohort Arm 1: Ocrelizumab + LP

RMS Cohort Arm 2: Ocrelizumab + LP

RMS Cohort Arm 3: Ocrelizumab + LP

RMS Cohort Arm 4: Ocrelizumab + LP

PPMS Cohort: Ocrelizumab + LP

Arm Description

Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.

Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.

Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.

Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.

For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.

Outcomes

Primary Outcome Measures

Change in Levels of NfL in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
RMS Cohort (Arms 1, 2, 3)
Change in Number of CD19+ B cells in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
RMS Cohort (Arms 1, 2, 3)
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
RMS Cohort (Arms 1, 2, 3)

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
August 28, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02688985
Brief Title
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
Official Title
An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2016 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 [control group]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the entire study will continue for approximately 4.5 years after the first infusion.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RMS Cohort Arm 1: Ocrelizumab + LP
Arm Type
Experimental
Arm Description
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Arm Title
RMS Cohort Arm 2: Ocrelizumab + LP
Arm Type
Experimental
Arm Description
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Arm Title
RMS Cohort Arm 3: Ocrelizumab + LP
Arm Type
Experimental
Arm Description
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Arm Title
RMS Cohort Arm 4: Ocrelizumab + LP
Arm Type
Experimental
Arm Description
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Arm Title
PPMS Cohort: Ocrelizumab + LP
Arm Type
Experimental
Arm Description
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Description
Ocrelizumab will be administered as IV infusion.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Puncture
Intervention Description
Participants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.
Intervention Type
Drug
Intervention Name(s)
Methyloprednisolone
Intervention Description
Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Intervention Description
Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.
Primary Outcome Measure Information:
Title
Change in Levels of NfL in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Description
RMS Cohort (Arms 1, 2, 3)
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Title
Change in Number of CD19+ B cells in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Description
RMS Cohort (Arms 1, 2, 3)
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Title
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Description
RMS Cohort (Arms 1, 2, 3)
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Other Pre-specified Outcome Measures:
Title
Change in Levels of NfL in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Description
PPMS Cohort
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Title
Change in Number of CD19+ B cells in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Description
PPMS Cohort
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Title
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Description
PPMS Cohort
Time Frame
From Baseline to post-treatment (Week 12, 24, 52, 144, or 240 according to randomization)
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
Time Frame
Predose (Hour 0) on Day 1 of Weeks 1, 24, 48; early termination (up to Week 52); every 24 weeks after Week 48 dose for 48 weeks or until B-cell count returns to baseline value or to lower limit of normal range (up to 6.5 years overall)
Title
Percentage of Participants With Adverse Events
Time Frame
From baseline up to approximately 6.5 years
Title
Serum Concentration of Ocrelizumab
Time Frame
Predose (Hour 0) on Day 1 of Weeks 1,24,48; at Weeks 12, 52; at early termination (up to Week 52); every 24 weeks after Week 48 dose for 48 weeks or until B-cell count returns to baseline value or to lower limit of normal range (up to 6.5 years overall)
Title
Ocrelizumab Levels in CSF
Description
RMS Cohort (Arms 1, 2, 3): predose (Hour 0) on Week 1 (baseline), at Weeks 12, 24, or 52 (according to randomization); RMS Cohort (Arm 4): Week -12 (pre-treatment baseline), predose (Hour 0) on Week 1 (treatment baseline), Week 12 (optional); PPMS Cohort: predose (Hour 0) on Week 1 (baseline) and Week 52.
Time Frame
Baseline up to Week 52 (detailed timeframe is provided in outcome description)

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: General Inclusion Criteria: For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer Inclusion Criteria Specific to RMS Participants: Diagnosis of RMS in accordance with the 2010 revised McDonald criteria Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®). At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment Inclusion Criteria Specific to RMS Cohort Arm 4 Participants: Must meet inclusion criteria for the RMS cohort Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4) Must be willing to remain on the same dose and regimen of current standard of care, or no treatment if treatment-naïve, for 12 weeks after study enrollment The treating and/or study physician must agree that the participant is eligible to remain on the same dose and regimen of their current standard of care at Screening, or to receive no treatment if the participant is treatment-naïve, for 12 weeks after study enrollment Inclusion Criteria Specific to PPMS Participants: Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria EDSS score of 3.0 - 6.5 points, inclusive, at Screening Disease duration from the onset of multiple sclerosis symptoms <10 years in participants with an EDSS at Screening less than or equal to (</=) 5.0 Documented history of either elevated immunoglobulin G (IgG) Index or one or more IgG oligoclonal bands (OCBs) detected by isoelectric focusing Exclusion Criteria: Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis) History of recurrent aspiration pneumonia requiring antibiotic therapy 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 with documented clean margins on pathology) History of or currently active primary or secondary immunodeficiency History of coagulation disorders History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies History of alcohol or other drug abuse within 24 weeks prior to enrollment Known presence or history of other neurologic disorders Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal, or any other significant disease Congestive heart failure (according to New York Heart Association III or IV functional severity) Known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study Contraindications or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label Contraindication for LP Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment Receipt of a live vaccine within 6 weeks prior to enrollment Systemic corticosteroid therapy within 4 weeks prior to Baseline Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for multiple sclerosis (such as treatment for chronic cerebrospinal venous insufficiency) Certain laboratory abnormalities or findings at Screening Inability to complete an MRI Lack of peripheral venous access Pregnant or lactating, or intending to become pregnant during the study Exclusion Criteria Specific to RMS Participants: Diagnosis of PPMS or secondary progressive multiple sclerosis without relapses
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
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine ; Pulmonary & Critical Care
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
City
New York
State/Province
New York
ZIP/Postal Code
63110
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Medical Research Foundation; MS Center of Excellence
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-0001
Country
United States
Facility Name
University of British Columbia Hospital Site; Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
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
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Karolinska Universitetssjukhuset, Solna
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

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