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A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
23-PPV
13-PCV Booster
Influenza Vaccine
KLH
OCR
TT Vaccine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of RMS in accordance with the revised McDonald criteria
  • Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
  • Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
  • For sexually active female participants of reproductive potential, use of reliable means of contraception

Exclusion Criteria:

  • Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
  • Known presence of other neurologic disorders
  • Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis

Sites / Locations

  • North Central Neurology Associates
  • Territory Neurology and Research Institute
  • Fullerton Neurology and Headache Center
  • Scripps Clinic
  • Neurology Associates PA
  • University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
  • University of South Florida
  • Michigan Institute for Neurological Disorders
  • The Minneapolis Clinic of Neurology
  • Mercy Hospital St. Louis / Mercy Clinic Neurology
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • University of New Mexico
  • Staten Island Univ Hospital
  • Ohio Health Research Institute Grant Medical Center
  • MDH Research LLC
  • Abington Neurological Associates
  • Neurology Clinic PC
  • Central Texas Neurology Consultants
  • Rocky Mountain MS Clinic
  • Swedish Medical Center
  • University of Calgary
  • University of British Columbia Hospital; Division of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A: OCR + Vaccines

Group B: Vaccines (Optional OCR in Extension)

Arm Description

Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.

Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. Participants who complete the 12-week immunization study period will have the option to receive two single infusions of OCR 300 mg, on Day 84 and Day 98, and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.

Outcomes

Primary Outcome Measures

Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.

Secondary Outcome Measures

Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Mean Levels of Anti-Tetanus Antibody
Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Anti-KLH antibody levels were assessed by ELISA.
Mean Levels of Anti-KLH Antibody: Ig M
Anti-KLH antibody levels were assessed by ELISA.
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Mean Levels of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Mean Level of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Percentage of Participants With Seroprotection
Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination.
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
2-fold increase from prevaccination HI titer.
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
4-fold increase from prevaccination HI titer.
Percentage of Participants With Seroconversion
Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer <10 and an HI titer >40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer <10 and HI titer >/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer >/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.
Strain-Specific Geometric Mean Titer Levels
Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Categorical Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Normalized Brain Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Volume of T2 Lesions: White Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Cortical Grey Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: T1 Unenhancing Lesion Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
MRI Parameters: Total Number of Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Cellular Immune Response Assessed by Flow Cytometry
Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul. Repleted is defined as CD19 >= LLN or baseline, whichever is lower.
Total Immunoglobulin
Percentage of Participants With Anti-Drug Antibody Formation
Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.

Full Information

First Posted
September 8, 2015
Last Updated
April 4, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02545868
Brief Title
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Official Title
A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2015 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
October 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. Study Description

Brief Summary
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: OCR + Vaccines
Arm Type
Experimental
Arm Description
Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.
Arm Title
Group B: Vaccines (Optional OCR in Extension)
Arm Type
Other
Arm Description
Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. Participants who complete the 12-week immunization study period will have the option to receive two single infusions of OCR 300 mg, on Day 84 and Day 98, and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.
Intervention Type
Biological
Intervention Name(s)
23-PPV
Intervention Description
The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).
Intervention Type
Biological
Intervention Name(s)
13-PCV Booster
Intervention Description
The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).
Intervention Type
Biological
Intervention Name(s)
KLH
Intervention Description
KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).
Intervention Type
Drug
Intervention Name(s)
OCR
Other Intervention Name(s)
RO4964913, PRO70769, rhuMAb 2H7
Intervention Description
OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.
Intervention Type
Biological
Intervention Name(s)
TT Vaccine
Intervention Description
The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
Primary Outcome Measure Information:
Title
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
Description
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Time Frame
8 weeks after TT vaccine
Secondary Outcome Measure Information:
Title
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
Description
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Time Frame
4 weeks after TT vaccine
Title
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
Description
For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Time Frame
4 weeks after TT vaccine
Title
Mean Levels of Anti-Tetanus Antibody
Description
Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Immediately prior to and at 4 and 8 weeks after TT vaccine
Title
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Description
Anti-KLH antibody levels were assessed by ELISA.
Time Frame
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Title
Mean Levels of Anti-KLH Antibody: Ig M
Description
Anti-KLH antibody levels were assessed by ELISA.
Time Frame
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Title
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Description
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.
Time Frame
4 weeks after 23-PPV
Title
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
Description
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Time Frame
4 weeks after 23-PPV
Title
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
Description
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Time Frame
4 weeks after 23-PPV
Title
Mean Levels of Anti-Pneumococcal Antibody
Description
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Time Frame
Immediately prior to and 4 weeks after 23-PPV
Title
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Description
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.
Time Frame
8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV
Title
Mean Level of Anti-Pneumococcal Antibody
Description
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Time Frame
Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV
Title
Percentage of Participants With Seroprotection
Description
Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination.
Time Frame
4 weeks after seasonal influenza vaccine administration
Title
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Description
2-fold increase from prevaccination HI titer.
Time Frame
4 weeks after seasonal influenza vaccine administration
Title
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Description
4-fold increase from prevaccination HI titer.
Time Frame
4 weeks after seasonal influenza vaccine administration
Title
Percentage of Participants With Seroconversion
Description
Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer <10 and an HI titer >40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer <10 and HI titer >/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer >/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.
Time Frame
4 weeks after influenza immunization
Title
Strain-Specific Geometric Mean Titer Levels
Description
Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.
Time Frame
Baseline and Week 4
Title
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Description
Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.
Time Frame
Immediately prior to and 4 weeks after influenza vaccine
Title
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Number of T2 Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Categorical Number of T2 Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Normalized Brain Volume
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Volume of T2 Lesions: White Matter Volume
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Cortical Grey Matter Volume
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: T1 Unenhancing Lesion Volume
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
MRI Parameters: Total Number of Lesions
Description
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time Frame
Baseline
Title
Cellular Immune Response Assessed by Flow Cytometry
Description
Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul. Repleted is defined as CD19 >= LLN or baseline, whichever is lower.
Time Frame
Days 1, 15, 85, 112, 140 and 169
Title
Total Immunoglobulin
Time Frame
Days 1, 85, and 169
Title
Percentage of Participants With Anti-Drug Antibody Formation
Description
Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.
Time Frame
Up to 24 Weeks (ISP)
Title
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.
Time Frame
During ISP (24 weeks for Group A and 12 weeks for Group B)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of RMS in accordance with the revised McDonald criteria Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive For sexually active female participants of reproductive potential, use of reliable means of contraception Exclusion Criteria: Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label Known presence of other neurologic disorders Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Territory Neurology and Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Fullerton Neurology and Headache Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Neurology Associates PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Michigan Institute for Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
The Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mercy Hospital St. Louis / Mercy Clinic Neurology
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Staten Island Univ Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10306
Country
United States
Facility Name
Ohio Health Research Institute Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
MDH Research LLC
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Rocky Mountain MS Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of British Columbia Hospital; Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32727835
Citation
Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

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