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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: NCT02637856
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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 Drug: Ocrelizumab
Enrollment 608
Recruitment Details The study was conducted in North America at 90 study sites in the U.S. and Canada.
Pre-assignment Details Participants with relapsing remitting multiple sclerosis (RRMS) were enrolled, who had had a suboptimal response to an adequate course of a disease-modifying treatment (DMT). An adequate course of prior DMT was defined as the same DMT administered for at least 6 months.
Arm/Group Title Ocrelizumab Ocrelizumab (Substudy)
Hide Arm/Group Description Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks) Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Period Title: Main Study (Baseline to Week 100)
Started 608 0
Completed 389 0
Not Completed 219 0
Reason Not Completed
Adverse Event             9             0
Lost to Follow-up             5             0
Physician Decision             2             0
Pregnancy             7             0
Withdrawal by Subject             20             0
Protocol Deviation             2             0
Continued on Commercial Ocrevus             164             0
Failed Drug Test             1             0
Incarceration             1             0
Pregnancy Attempts             2             0
Site Closing             6             0
Period Title: Sub-Study (Week 72 to Week 100)
Started 0 129
Completed 0 125
Not Completed 0 4
Reason Not Completed
Non-safety reason (moved out of state)             0             1
Lost to Follow-up             0             3
Arm/Group Title Ocrelizumab
Hide Arm/Group Description Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Baseline Participants 608
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 608 participants
37.2  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 608 participants
Female
438
  72.0%
Male
170
  28.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 608 participants
Hispanic or Latino
68
  11.2%
Not Hispanic or Latino
526
  86.5%
Not Stated
7
   1.2%
Unknown
7
   1.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 608 participants
American Indian or Alaska Native
2
   0.3%
Asian
13
   2.1%
Black or African American
72
  11.8%
Multiple
6
   1.0%
Native Hawaiian or other Pacific Islande
3
   0.5%
Unknown
17
   2.8%
White
495
  81.4%
1.Primary Outcome
Title Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period
Hide Description Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
48.1
(43.9 to 52.3)
2.Primary Outcome
Title Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy
Hide Description Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion
Time Frame Week 96 to Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious IRRs throughout the main study
Arm/Group Title Ocrelizumab (Substudy)
Hide Arm/Group Description:
Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Overall Number of Participants Analyzed 129
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0
(0.0 to 2.8)
3.Secondary Outcome
Title Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period
Hide Description Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time Frame Baseline up to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 24 Number Analyzed 576 participants
59.0
(54.9 to 63.1)
Week 48 Number Analyzed 576 participants
51.2
(47.0 to 55.4)
4.Secondary Outcome
Title Time to Protocol-Defined Event
Hide Description Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(53.86 to NA)
[1]
Not estimable because more than 50% of the ITT population were event-free at the end of the study
5.Secondary Outcome
Title Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period
Hide Description Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1)
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number of Relapses/Participant Year
0.046
(0.036 to 0.060)
6.Secondary Outcome
Title Time to Onset of First Protocol-Defined Relapse
Hide Description Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Not estimable because more than 50% of the ITT population were event-free at the end of the study
7.Secondary Outcome
Title Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI
Hide Description [Not Specified]
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Not estimable because more than 50% of the ITT population were event-free at the end of the study
8.Secondary Outcome
Title Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI
Hide Description [Not Specified]
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Not estimable because more than 50% of the ITT population were event-free at the end of the study
9.Secondary Outcome
Title Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score
Hide Description [Not Specified]
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Not estimable because more than 50% of the ITT population were event-free at the end of the study
10.Secondary Outcome
Title Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Hide Description The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.
Time Frame Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Unit of Measure: Number of Lesions
Week 24 Number Analyzed 599 participants
33
Week 48 Number Analyzed 582 participants
16
Week 96 Number Analyzed 557 participants
7
11.Secondary Outcome
Title Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI
Hide Description Baseline data is represented as mean; post-Baseline date are represented as mean changes.
Time Frame Baseline, Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Mean (Standard Error)
Unit of Measure: cubic centimeter (cm3)
Baseline Number Analyzed 600 participants
11.551  (0.590)
Week 24 Number Analyzed 595 participants
-0.484  (0.118)
Week 48 Number Analyzed 579 participants
-0.549  (0.123)
Week 96 Number Analyzed 554 participants
-0.560  (0.129)
12.Secondary Outcome
Title Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI
Hide Description [Not Specified]
Time Frame Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Unit of Measure: Number of Lesions
Week 24 Number Analyzed 598 participants
640
Week 48 Number Analyzed 583 participants
39
Week 96 Number Analyzed 558 participants
38
13.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Baseline up to 100 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab
Arm/Group Title Ocrelizumab
Hide Arm/Group Description:
Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)
Overall Number of Participants Analyzed 608
Measure Type: Number
Unit of Measure: Percentage of Participants
86.3
Time Frame Baseline up to 100 weeks
Adverse Event Reporting Description The Safety Population included all enrolled participants who received any ocrelizumab.
 
Arm/Group Title Ocrelizumab Ocrelizumab (Substudy)
Hide Arm/Group Description Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks) Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
All-Cause Mortality
Ocrelizumab Ocrelizumab (Substudy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/608 (0.00%)      0/129 (0.00%)    
Hide Serious Adverse Events
Ocrelizumab Ocrelizumab (Substudy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/608 (7.73%)      2/129 (1.55%)    
Blood and lymphatic system disorders     
Anaemia  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Leukopenia  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Wolff-Parkinson-White syndrome  1  1/608 (0.16%)  2 0/129 (0.00%)  0
Ear and labyrinth disorders     
Mastoid effusion  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Abdominal pain lower  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Crohn's disease  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Pancreatitis  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Vomiting  1  1/608 (0.16%)  1 0/129 (0.00%)  0
General disorders     
Chest pain  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Systemic inflammatory response syndrome  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Cholecystitis acute  1  2/608 (0.33%)  2 0/129 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Drug hypersensitivity  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Infections and infestations     
Appendicitis  1  3/608 (0.49%)  3 0/129 (0.00%)  0
Gastroenteritis viral  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Kidney infection  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Pyelonephritis  1  2/608 (0.33%)  2 0/129 (0.00%)  0
Urinary tract infection  1  2/608 (0.33%)  2 0/129 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Fall  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Lower limb fracture  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Multiple injuries  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Road traffic accident  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Subdural haematoma  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/608 (0.16%)  1 1/129 (0.78%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of the cervix  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Breast cancer metastatic  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Lung neoplasm malignant  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Neoplasm  1  1/608 (0.16%)  1 1/129 (0.78%)  1
Nervous system disorders     
Encephalopathy  1  2/608 (0.33%)  2 0/129 (0.00%)  0
Multiple sclerosis relapse  1  3/608 (0.49%)  3 0/129 (0.00%)  0
Neuralgia  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Seizure  1  2/608 (0.33%)  3 0/129 (0.00%)  0
Syncope  1  2/608 (0.33%)  2 0/129 (0.00%)  0
Trigeminal neuralgia  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Psychiatric disorders     
Depression  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Suicidal ideation  1  3/608 (0.49%)  3 0/129 (0.00%)  0
Suicide attempt  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Surgical and medical procedures     
Cardiac ablation  1  1/608 (0.16%)  1 0/129 (0.00%)  0
Vascular disorders     
Fibromuscular dysplasia  1  1/608 (0.16%)  1 0/129 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocrelizumab Ocrelizumab (Substudy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   406/608 (66.78%)      16/129 (12.40%)    
Gastrointestinal disorders     
Nausea  1  32/608 (5.26%)  38 0/129 (0.00%)  0
General disorders     
Fatigue  1  58/608 (9.54%)  62 0/129 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  64/608 (10.53%)  81 0/129 (0.00%)  0
Sinusitis  1  37/608 (6.09%)  47 0/129 (0.00%)  0
Upper respiratory tract infection  1  57/608 (9.38%)  76 0/129 (0.00%)  0
Urinary tract infection  1  88/608 (14.47%)  118 0/129 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  263/608 (43.26%)  519 16/129 (12.40%)  16
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  36/608 (5.92%)  41 0/129 (0.00%)  0
Nervous system disorders     
Headache  1  56/608 (9.21%)  66 0/129 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
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
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02637856    
Other Study ID Numbers: MN30035
First Submitted: December 18, 2015
First Posted: December 22, 2015
Results First Submitted: April 15, 2020
Results First Posted: May 26, 2020
Last Update Posted: May 26, 2020