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)

• 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: Genentech, Inc.
• 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

Participant Flow

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)
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

Baseline Characteristics

Arm/Group Title		Ocrelizumab
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline up to Week 96

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline up to Week 96

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline up to Week 96

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Baseline data is represented as mean; post-Baseline date are represented as mean changes.
Time Frame	Baseline, Weeks 24, 48, and 96

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Weeks 24, 48, and 96

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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

Adverse Events

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)
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Medical Communications
• Organization: Hoffmann-La Roche
• Phone: 800 821-8590
• EMail: genentech@druginfo.com

• 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