Study to Explore the Mechanism of Action of Ocrelizumab a... | NCT02688985 | Trialant
NCT02688985
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Jun 4, 2024Actual
Enrollment
131Actual
Phase
Phase 3
Conditions
Relapsing Multiple Sclerorsis
Multiple Sclerosis, Primary Progressive
Interventions
Ocrelizumab
Lumbar Puncture
Methyloprednisolone
Antihistamine
Countries
United States
Canada
Germany
Sweden
Protocol Section
Identification Module
NCT ID
NCT02688985
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ML29966
Secondary IDs
ID
Type
Description
Link
2015-004616-37
EudraCT Number
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
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 29, 2016Actual
Primary Completion Date
Apr 11, 2023Actual
Completion Date
Apr 11, 2023Actual
First Submitted Date
Feb 18, 2016
First Submission Date that Met QC Criteria
Feb 18, 2016
First Posted Date
Feb 23, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2024
Results First Submitted that Met QC Criteria
May 7, 2024
Results First Posted Date
Jun 4, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 7, 2024
Last Update Posted Date
Jun 4, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Relapsing Multiple Sclerorsis
Multiple Sclerosis, Primary Progressive
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
131Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
RMS Cohort Arm 1: Ocrelizumab + LP
Experimental
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.
Drug: Ocrelizumab
Procedure: Lumbar Puncture
Drug: Methyloprednisolone
Drug: Antihistamine
RMS Cohort Arm 2: Ocrelizumab + LP
Experimental
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.
Drug: Ocrelizumab
Procedure: Lumbar Puncture
Drug: Methyloprednisolone
Drug: Antihistamine
RMS Cohort Arm 3: Ocrelizumab + LP
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ocrelizumab
Drug
Ocrelizumab will be administered as IV infusion.
PPMS Cohort: Ocrelizumab + LP
RMS Cohort Arm 1: Ocrelizumab + LP
RMS Cohort Arm 2: Ocrelizumab + LP
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Primary Analysis was based on following data-cut off:
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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 (\
MacMillan EL, Russell-Schulz B, Alejo G, Harp C, Cameron B, Winger R, Jia S, Herman A, Kassam J, Waine M, Vavasour IM, Cross H, Tam R, Traboulsee AL, Carruthers R, Kolind SH. Longitudinal magnetic resonance spectroscopy study of metabolite changes over 2 years in relapsing and primary progressive multiple sclerosis treated with ocrelizumab. Mult Scler. 2026 Jun 30:13524585261456964. doi: 10.1177/13524585261456964. Online ahead of print.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
131 patients enrolled at 17 study locations in the U.S., Canada, Germany, and Sweden
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 21, 2016
Apr 10, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ocrelizumab
Procedure: Lumbar Puncture
Drug: Methyloprednisolone
Drug: Antihistamine
RMS Cohort Arm 4: Ocrelizumab + LP
Experimental
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.
Drug: Ocrelizumab
Procedure: Lumbar Puncture
Drug: Methyloprednisolone
Drug: Antihistamine
PPMS Cohort: Ocrelizumab + LP
Experimental
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.
Drug: Ocrelizumab
Procedure: Lumbar Puncture
Drug: Methyloprednisolone
Drug: Antihistamine
RMS Cohort Arm 3: Ocrelizumab + LP
RMS Cohort Arm 4: Ocrelizumab + LP
RO4964913
Lumbar Puncture
Procedure
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.
PPMS Cohort: Ocrelizumab + LP
RMS Cohort Arm 1: Ocrelizumab + LP
RMS Cohort Arm 2: Ocrelizumab + LP
RMS Cohort Arm 3: Ocrelizumab + LP
RMS Cohort Arm 4: Ocrelizumab + LP
Methyloprednisolone
Drug
Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.
PPMS Cohort: Ocrelizumab + LP
RMS Cohort Arm 1: Ocrelizumab + LP
RMS Cohort Arm 2: Ocrelizumab + LP
RMS Cohort Arm 3: Ocrelizumab + LP
RMS Cohort Arm 4: Ocrelizumab + LP
Antihistamine
Drug
Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.
PPMS Cohort: Ocrelizumab + LP
RMS Cohort Arm 1: Ocrelizumab + LP
RMS Cohort Arm 2: Ocrelizumab + LP
RMS Cohort Arm 3: Ocrelizumab + LP
RMS Cohort Arm 4: Ocrelizumab + LP
San Francisco
California
94115
United States
University Of Colorado
Aurora
Colorado
80045
United States
Yale University School of Medicine ; Pulmonary & Critical Care
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.
FG002
RMS Cohort Arm 3: Ocrelizumab + LP
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.
FG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
FG004
PPMS Cohort: Ocrelizumab + LP
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.
FG00023 subjects
FG00131 subjects
FG00228 subjects
FG00318 subjects
FG00431 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
NOT COMPLETED
FG00023 subjects
FG00131 subjects
FG00228 subjects
FG00318 subjects
FG00430 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Continued Onto Commercially Available Ocrelizumab
FG00012 subjects
FG00112 subjects
FG00214 subjects
FG00314 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Non-Compliance With Study Drug
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Study Terminated By Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0018 subjects
FG0027 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
BG001
RMS Cohort Arm 2: Ocrelizumab + LP
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.
BG002
RMS Cohort Arm 3: Ocrelizumab + LP
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.
BG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
BG004
PPMS Cohort: Ocrelizumab + LP
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG00131
BG00228
BG00318
BG00431
BG005131
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00036.0± 10.4
BG00138.7± 10.4
BG002
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Male
Title
Measurements
BG0008
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Primary Analysis was based on following data-cut off:
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Posted
Mean
Standard Deviation
pg/mL
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
ID
Title
Description
OG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
OG001
RMS Cohort Arm 2: Ocrelizumab + LP
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.
OG002
RMS Cohort Arm 3: Ocrelizumab + LP
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.
OG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
OG004
PPMS Cohort: Ocrelizumab + LP
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.
Units
Counts
Participants
OG00021
OG00125
OG00222
OG003
Title
Denominators
Categories
Primary Analysis
Title
Measurements
OG000-1232.97± 2060.37
OG001-1169.13± 1739.49
OG002-1008.13± 1132.68
OG003
Primary
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Posted
Mean
Standard Deviation
cells/μL
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
ID
Title
Description
OG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
OG001
RMS Cohort Arm 2: Ocrelizumab + LP
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.
Primary
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus
Posted
Mean
Standard Deviation
cells/μL
From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
ID
Title
Description
OG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
OG001
RMS Cohort Arm 2: Ocrelizumab + LP
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.
Time Frame
From baseline up to 5 years
Description
Safety population is defined as all enrolled patients who received at least one infusion of ocrelizumab, even if the infusion was incomplete.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
RMS Cohort Arm 1: Ocrelizumab + LP
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.
1
23
5
23
23
23
EG001
RMS Cohort Arm 2: Ocrelizumab + LP
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.
0
31
5
31
28
31
EG002
RMS Cohort Arm 3: Ocrelizumab + LP
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.
0
28
1
28
27
28
EG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
0
18
5
18
17
18
EG004
PPMS Cohort: Ocrelizumab + LP
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.
1
31
9
31
31
31
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected28 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected31 at risk
Crohn's disease
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Enteritis
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Appendicitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
COVID-19
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Cellulitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0003 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Influenza
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pharyngitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Seronegative arthritis
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Myelitis transverse
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Seizure
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Assisted suicide
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Completed suicide
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Mania
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG0031 events1 affected18 at risk
EG0040 events0 affected31 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Palpitations
Cardiac disorders
MedRA 26.0
Systematic Assessment
EG0003 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Tachycardia
Cardiac disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Inner ear inflammation
Ear and labyrinth disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events1 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Eye pain
Eye disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Ocular hyperaemia
Eye disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Vision blurred
Eye disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Nausea
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0013 events3 affected31 at risk
EG0025 events4 affected28 at risk
EG003
Vomiting
Gastrointestinal disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Chest discomfort
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Facial pain
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Fatigue
General disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected28 at risk
EG003
Gait disturbance
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Influenza like illness
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0024 events2 affected28 at risk
EG003
Oedema peripheral
General disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pain
General disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Peripheral swelling
General disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Puncture site pain
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pyrexia
General disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0014 events3 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Vessel puncture site pain
General disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Seasonal allergy
Immune system disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Bronchitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0015 events5 affected31 at risk
EG0023 events2 affected28 at risk
EG003
COVID-19
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0004 events4 affected23 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Conjunctivitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Ear infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Gastroenteritis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Herpes zoster
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Impetigo
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Infected cyst
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Influenza
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Nail bed infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Nasopharyngitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0024 events3 affected28 at risk
EG003
Oral candidiasis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0013 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Oral herpes
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pharyngitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pyelonephritis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Respiratory tract infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Rhinitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Sinusitis
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0005 events4 affected23 at risk
EG00113 events10 affected31 at risk
EG0025 events4 affected28 at risk
EG003
Tooth infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG00010 events7 affected23 at risk
EG00112 events6 affected31 at risk
EG00219 events10 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0005 events4 affected23 at risk
EG0016 events5 affected31 at risk
EG0029 events5 affected28 at risk
EG003
Vaginal infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Viral infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0012 events2 affected31 at risk
EG0025 events4 affected28 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG00036 events15 affected23 at risk
EG00113 events9 affected31 at risk
EG00232 events16 affected28 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0003 events2 affected23 at risk
EG0015 events4 affected31 at risk
EG0027 events4 affected28 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0002 events1 affected23 at risk
EG0012 events2 affected31 at risk
EG0022 events1 affected28 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0004 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Blood iron decreased
Investigations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Blood uric acid increased
Investigations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Body temperature increased
Investigations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Influenza A virus test positive
Investigations
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Occult blood
Investigations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Weight increased
Investigations
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0013 events3 affected31 at risk
EG0025 events4 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0025 events3 affected28 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0023 events2 affected28 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0024 events2 affected28 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0015 events4 affected31 at risk
EG0026 events5 affected28 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Balance disorder
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Burning sensation
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0023 events1 affected28 at risk
EG003
Cognitive disorder
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Coordination abnormal
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Dizziness
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Dysarthria
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Headache
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0004 events2 affected23 at risk
EG00110 events6 affected31 at risk
EG0024 events4 affected28 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected28 at risk
EG003
Lhermitte's sign
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected28 at risk
EG003
Migraine
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0014 events4 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0003 events3 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Multiple sclerosis pseudo relapse
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0005 events3 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Muscle spasticity
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Paraesthesia
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0004 events3 affected23 at risk
EG0013 events2 affected31 at risk
EG0025 events4 affected28 at risk
EG003
Restless arm syndrome
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Sensory disturbance
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Sinus headache
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Somnolence
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Tremor
Nervous system disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Anxiety
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Depressed mood
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Depression
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Insomnia
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected28 at risk
EG003
Panic attack
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Restlessness
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Sleep disorder
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Somnambulism
Psychiatric disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Dysuria
Renal and urinary disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Urinary retention
Renal and urinary disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected28 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedRA 26.0
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected28 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events2 affected31 at risk
EG0025 events3 affected28 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedRA 26.0
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected28 at risk
EG003
Peripheral coldness
Vascular disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Vasculitis
Vascular disorders
MedRA 26.0
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected28 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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.
OG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
OG004
PPMS Cohort: Ocrelizumab + LP
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.
Units
Counts
Participants
OG00021
OG00125
OG00222
OG00316
OG00428
Title
Denominators
Categories
Primary Analysis
Title
Measurements
OG000-0.22± 0.26
OG001-0.15± 0.36
OG002-0.13± 0.32
OG003-0.18± 0.37
OG004-0.09± 0.11
LTE phase Week 144
Title
Measurements
OG000-0.11± 0.08
OG001-0.14± 0.20
OG002-0.06± 0.23
OG003
LTE phase Week 240
Title
Measurements
OG000-0.08± 0.09
OG001-0.20± 0.26
OG002-0.02± 0.01
OG003
OG002
RMS Cohort Arm 3: Ocrelizumab + LP
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.
OG003
RMS Cohort Arm 4: Ocrelizumab + LP
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.
OG004
PPMS Cohort: Ocrelizumab + LP
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.