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A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

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ClinicalTrials.gov Identifier: NCT02861014
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : February 3, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention Biological: Ocrelizumab
Enrollment 681
Recruitment Details One additional participant was initially enrolled in error and the information provided is based on the ITT population.
Pre-assignment Details  
Arm/Group Title Ocrelizumab
Hide Arm/Group Description Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Period Title: Overall Study
Started 680
Completed 641
Not Completed 39
Reason Not Completed
Adverse Event             7
Death             1
Lack of Efficacy             3
Physician Decision             2
Pregnancy             4
Protocol Violation             2
Study Terminated By Sponsor             3
Withdrawal by Subject             14
Commercial ocrelizumab             3
Arm/Group Title Ocrelizumab
Hide Arm/Group Description Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Baseline Participants 680
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 680 participants
34.2  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 680 participants
Female
436
  64.1%
Male
244
  35.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 680 participants
Hispanic or Latino
27
   4.0%
Not Hispanic or Latino
579
  85.1%
Unknown or Not Reported
74
  10.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 680 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.1%
White
625
  91.9%
More than one race
2
   0.3%
Unknown or Not Reported
49
   7.2%
1.Primary Outcome
Title Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
Hide Description

A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:

  • A protocol-defined relapse (PDR)
  • 24-week CDP based on increase in EDSS while on treatment with ocrelizumab
  • A T1 Gd-enhanced lesion after Week 8
  • A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 658
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
74.8
(71.3 to 78.0)
2.Secondary Outcome
Title Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
Hide Description

A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:

  • A protocol-defined relapse (PDR)
  • 24-week CDP based on increase in EDSS while on treatment with ocrelizumab
  • A T1 Gd-enhanced lesion after Week 8
  • A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame Baseline up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 673
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
87.1
(84.3 to 89.5)
3.Secondary Outcome
Title Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
Hide Description

A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:

  • A protocol-defined relapse (PDR)
  • 24-week CDP based on increase in EDSS while on treatment with ocrelizumab
  • A T1 Gd-enhanced lesion after Week 8
  • A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame Baseline up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 665
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
82.6
(79.5 to 85.4)
4.Secondary Outcome
Title Time to First Protocol-Defined Event of Disease Activity
Hide Description

The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab:

  • A protocol-defined relapse defined as: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment
  • 24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab
  • A T1 Gd-enhanced lesion after Week 8
  • A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan.
Time Frame Baseline up to 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events
5.Secondary Outcome
Title Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
Hide Description The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame Baseline, Weeks: 24, 48, 72, 96
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Mean (Standard Deviation)
Unit of Measure: Points on scale
Baseline Number Analyzed 680 participants
2.09  (1.06)
Week 24 Number Analyzed 679 participants
-0.02  (0.64)
Week 48 Number Analyzed 665 participants
0.01  (0.82)
Week 72 Number Analyzed 650 participants
-0.03  (0.85)
Week 96 Number Analyzed 640 participants
-0.01  (0.85)
6.Secondary Outcome
Title Absolute Change From Baseline in EDSS Category at Week 96
Hide Description The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 640
Measure Type: Number
Unit of Measure: Percentage of Participants
Worsened (>0.5) 13.4
Stable (Change <= 0.5 and >= -0.5) 72.2
Improved (<-0.5) 14.4
7.Secondary Outcome
Title Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96
Hide Description The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of Participants
17.3
8.Secondary Outcome
Title Annualized Protocol-defined Relapse Rate at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Relapses per participant per year
0.030
(0.023 to 0.038)
9.Secondary Outcome
Title Time to Onset of 24-week Confirmed Disability Progression
Hide Description [Not Specified]
Time Frame Baseline up to 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
10.Secondary Outcome
Title Time to Onset of First Protocol-Defined Relapse
Hide Description

A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria:

  • Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications)
  • Symptoms should be preceded by neurological stability for at least 30 days
  • Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least:

    • ≥ 0.5 points on EDSS scale
    • or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
    • or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
Time Frame Baseline up to 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with event.
11.Secondary Outcome
Title Time to Onset of First New and/or Enlarging T2 Lesion
Hide Description [Not Specified]
Time Frame Baseline up to 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with event.
12.Secondary Outcome
Title Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96
Hide Description Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans
Time Frame Weeks: 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 665
Mean (95% Confidence Interval)
Unit of Measure: Lesions per scan
Week 24 Number Analyzed 665 participants
0.004
(0.001 to 0.014)
Week 48 Number Analyzed 658 participants
0.004
(0.001 to 0.011)
Week 96 Number Analyzed 629 participants
NA [1] 
(NA to NA)
[1]
No result could be obtained for Week 96, as the model did not converge.
13.Secondary Outcome
Title Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 632
Mean (Standard Deviation)
Unit of Measure: mL
-558.6  (1194.6)
14.Secondary Outcome
Title Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 632
Mean (Standard Deviation)
Unit of Measure: Percentage Change From Baseline
-8.5  (18.2)
15.Secondary Outcome
Title Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96
Hide Description The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis.
Time Frame Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 670
Mean (Standard Deviation)
Unit of Measure: uL
Week 24 Number Analyzed 670 participants
21.4  (241.7)
Week 48 Number Analyzed 666 participants
23.1  (510.2)
Week 96 Number Analyzed 631 participants
3.7  (41.6)
16.Secondary Outcome
Title Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan
Hide Description Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans
Time Frame Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 671
Mean (95% Confidence Interval)
Unit of Measure: Lesions per scan
Week 24 Number Analyzed 671 participants
0.053
(0.038 to 0.075)
Week 48 Number Analyzed 666 participants
0.009
(0.004 to 0.017)
Week 96 Number Analyzed 636 participants
0.011
(0.006 to 0.020)
17.Secondary Outcome
Title Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Hide Description [Not Specified]
Time Frame Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 666
Mean (Standard Deviation)
Unit of Measure: mL
Week 48 Number Analyzed 666 participants
-416.5  (1224.3)
Week 96 Number Analyzed 635 participants
-528.5  (1144.7)
18.Secondary Outcome
Title Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Hide Description [Not Specified]
Time Frame Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
Week 48 Number Analyzed 666 participants
-4.0  (149.7)
Week 96 Number Analyzed 635 participants
-12.5  (21.1)
19.Secondary Outcome
Title Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Hide Description [Not Specified]
Time Frame Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 666
Mean (95% Confidence Interval)
Unit of Measure: mL
Week 48 Number Analyzed 666 participants
-461.8
(-613.8 to -309.7)
Week 96 Number Analyzed 635 participants
-576.5
(-727.0 to -426.1)
20.Secondary Outcome
Title Adjusted Mean Percentage Change From Baseline in Brain Volume
Hide Description [Not Specified]
Time Frame Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 538
Mean (95% Confidence Interval)
Unit of Measure: Mean percentage change from baseline
Week 24 Number Analyzed 538 participants
-0.153
(-0.259 to -0.047)
Week 48 Number Analyzed 518 participants
-0.445
(-0.556 to -0.334)
Week 96 Number Analyzed 484 participants
-0.805
(-0.940 to -0.669)
21.Secondary Outcome
Title Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
Hide Description [Not Specified]
Time Frame Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 432
Mean (95% Confidence Interval)
Unit of Measure: Mean percentage change from baseline
Week 48 Number Analyzed 432 participants
-0.312
(-0.606 to -0.019)
Week 96 Number Analyzed 395 participants
-0.618
(-0.928 to -0.308)
22.Secondary Outcome
Title Adjusted Mean Percentage Change From Baseline in White Matter Volume
Hide Description [Not Specified]
Time Frame Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 432
Mean (95% Confidence Interval)
Unit of Measure: Mean percentage change from baseline
Week 48 Number Analyzed 432 participants
-0.382
(-0.609 to -0.154)
Week 96 Number Analyzed 395 participants
-0.745
(-0.983 to -0.507)
23.Secondary Outcome
Title Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Hide Description Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span. The higher the results, the better processing speed/working memory.
Time Frame Baseline, Weeks: 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 610
Mean (Standard Deviation)
Unit of Measure: Correct responses over 90 seconds
Baseline Number Analyzed 610 participants
53.8  (13.0)
Week 48 Number Analyzed 610 participants
2.5  (9.8)
Week 96 Number Analyzed 599 participants
1.3  (10.2)
24.Secondary Outcome
Title Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Hide Description Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Time Frame Baseline, Weeks 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 599
Mean (Standard Deviation)
Unit of Measure: Points on scale
Baseline Number Analyzed 599 participants
25.0  (6.3)
Week 48 Number Analyzed 599 participants
-1.9  (5.3)
Week 96 Number Analyzed 581 participants
-1.5  (5.4)
25.Secondary Outcome
Title Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Hide Description Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span.
Time Frame Baseline, Weeks 48, 96
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Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
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Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 610
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
Week 48 Number Analyzed 610 participants
7.2  (30.8)
Week 96 Number Analyzed 599 participants
4.8  (30.6)
26.Secondary Outcome
Title Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Hide Description Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Time Frame Baseline, Weeks: 48, 96
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Hide Analysis Population Description
All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 599
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
Week 48 Number Analyzed 599 participants
-4.4  (31.1)
Week 96 Number Analyzed 581 participants
-2.0  (33.7)
27.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Baseline up to to 96 weeks after the end of the Treatment Period
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Hide Analysis Population Description
Safety analyses were done on the ITT population.
Arm/Group Title Ocrelizumab
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Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Overall Number of Participants Analyzed 680
Measure Type: Number
Unit of Measure: Percentage of Participants
Any AE 89.1
SAE 7.2
Deaths 0.1
AEs leading to study drug discontinuation 1.0
SAEs leading to study drug discontinuation 0.7
AEs leading to dose modification/interruptionb 15.0
Infusion-related reactions (IRRs) 43.2
Serious IRRs 0.1
Infections 66.9
Serious infections 1.6
Malignancies 0.4
Pregnancies 0.7
Time Frame From Baseline up to to 96 weeks after the end of the Treatment Period
Adverse Event Reporting Description One participant discontinued the study before receiving treatment and was excluded from safety population.
 
Arm/Group Title Ocrelizumab
Hide Arm/Group Description Participants received Ocrelizumab as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
All-Cause Mortality
Ocrelizumab
Affected / at Risk (%)
Total   1/680 (0.15%)    
Hide Serious Adverse Events
Ocrelizumab
Affected / at Risk (%) # Events
Total   49/680 (7.21%)    
Blood and lymphatic system disorders   
GRANULOCYTOPENIA  1  1/680 (0.15%)  1
Cardiac disorders   
ANGINA PECTORIS  1  1/680 (0.15%)  1
MYOCARDIAL INFARCTION  1  1/680 (0.15%)  1
Ear and labyrinth disorders   
VERTIGO  1  1/680 (0.15%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN LOWER  1  1/680 (0.15%)  1
ANAL FISTULA  1  1/680 (0.15%)  1
COLITIS ULCERATIVE  1  1/680 (0.15%)  1
CROHN'S DISEASE  1  1/680 (0.15%)  1
ENTEROCOLITIS  1  1/680 (0.15%)  1
LUMBAR HERNIA  1  1/680 (0.15%)  1
MELAENA  1  1/680 (0.15%)  1
TOOTHACHE  1  1/680 (0.15%)  1
General disorders   
OEDEMA  1  1/680 (0.15%)  1
Hepatobiliary disorders   
HEPATITIS  1  1/680 (0.15%)  1
Infections and infestations   
ANAL ABSCESS  1  1/680 (0.15%)  1
GASTROENTERITIS  1  1/680 (0.15%)  1
OESOPHAGITIS BACTERIAL  1  1/680 (0.15%)  1
ORAL BACTERIAL INFECTION  1  1/680 (0.15%)  1
PNEUMONIA  1  2/680 (0.29%)  2
SEPSIS  1  1/680 (0.15%)  1
SINUSITIS  1  3/680 (0.44%)  3
SUPERINFECTION FUNGAL  1  1/680 (0.15%)  1
URINARY TRACT INFECTION  1  1/680 (0.15%)  1
VARICELLA ZOSTER VIRUS INFECTION  1  1/680 (0.15%)  1
VIRAL INFECTION  1  1/680 (0.15%)  1
Injury, poisoning and procedural complications   
ANKLE FRACTURE  1  1/680 (0.15%)  1
FACIAL BONES FRACTURE  1  1/680 (0.15%)  1
INFUSION RELATED REACTION  1  1/680 (0.15%)  1
RIB FRACTURE  1  1/680 (0.15%)  1
TENDON INJURY  1  1/680 (0.15%)  1
URETERIC INJURY  1  1/680 (0.15%)  1
UTERINE RUPTURE  1  1/680 (0.15%)  1
Musculoskeletal and connective tissue disorders   
INTERVERTEBRAL DISC PROTRUSION  1  1/680 (0.15%)  1
OSTEONECROSIS  1  1/680 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  1/680 (0.15%)  1
BENIGN NEOPLASM OF THYMUS  1  1/680 (0.15%)  1
SQUAMOUS CELL CARCINOMA OF THE CERVIX  1  1/680 (0.15%)  1
Nervous system disorders   
CEREBRAL VENOUS SINUS THROMBOSIS  1  1/680 (0.15%)  1
GENERALISED TONIC-CLONIC SEIZURE  1  1/680 (0.15%)  1
HEADACHE  1  1/680 (0.15%)  1
MIGRAINE  1  1/680 (0.15%)  1
MULTIPLE SCLEROSIS RELAPSE  1  3/680 (0.44%)  5
STATUS MIGRAINOSUS  1  1/680 (0.15%)  2
SUBARACHNOID HAEMORRHAGE  1  1/680 (0.15%)  1
Pregnancy, puerperium and perinatal conditions   
ABORTION SPONTANEOUS  1  1/680 (0.15%)  2
Psychiatric disorders   
COMPLETED SUICIDE  1  1/680 (0.15%)  1
DELIRIUM  1  1/680 (0.15%)  1
DEPRESSION  1  1/680 (0.15%)  1
DEPRESSION SUICIDAL  1  1/680 (0.15%)  1
HALLUCINATION  1  1/680 (0.15%)  2
SUICIDE ATTEMPT  1  1/680 (0.15%)  1
Reproductive system and breast disorders   
HAEMORRHAGIC OVARIAN CYST  1  1/680 (0.15%)  1
TESTICULAR INFARCTION  1  1/680 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
NASAL ULCER  1  1/680 (0.15%)  1
Skin and subcutaneous tissue disorders   
DERMATITIS ALLERGIC  1  1/680 (0.15%)  1
DERMATITIS ATOPIC  1  1/680 (0.15%)  1
GUTTATE PSORIASIS  1  1/680 (0.15%)  1
URTICARIA  1  1/680 (0.15%)  1
Vascular disorders   
SHOCK HAEMORRHAGIC  1  1/680 (0.15%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocrelizumab
Affected / at Risk (%) # Events
Total   531/680 (78.09%)    
Gastrointestinal disorders   
DIARRHOEA  1  42/680 (6.18%)  52
NAUSEA  1  38/680 (5.59%)  40
General disorders   
FATIGUE  1  67/680 (9.85%)  106
PYREXIA  1  47/680 (6.91%)  62
Infections and infestations   
INFLUENZA  1  92/680 (13.53%)  137
NASOPHARYNGITIS  1  210/680 (30.88%)  449
ORAL HERPES  1  55/680 (8.09%)  116
SINUSITIS  1  36/680 (5.29%)  58
UPPER RESPIRATORY TRACT INFECTION  1  51/680 (7.50%)  81
URINARY TRACT INFECTION  1  70/680 (10.29%)  108
Injury, poisoning and procedural complications   
INFUSION RELATED REACTION  1  294/680 (43.24%)  569
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  37/680 (5.44%)  40
BACK PAIN  1  57/680 (8.38%)  74
PAIN IN EXTREMITY  1  47/680 (6.91%)  58
Nervous system disorders   
HEADACHE  1  154/680 (22.65%)  320
PARAESTHESIA  1  34/680 (5.00%)  47
Psychiatric disorders   
INSOMNIA  1  34/680 (5.00%)  43
Respiratory, thoracic and mediastinal disorders   
COUGH  1  47/680 (6.91%)  56
OROPHARYNGEAL PAIN  1  42/680 (6.18%)  55
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02861014    
Other Study ID Numbers: MA30005
2015-005597-38 ( EudraCT Number )
First Submitted: August 5, 2016
First Posted: August 10, 2016
Results First Submitted: October 13, 2020
Results First Posted: February 3, 2021
Last Update Posted: March 26, 2021