Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03606460 | Multiple Sclerosis
Previous Study | Return to List | Next Study

A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606460
Recruitment Status : Completed
First Posted : July 30, 2018
Results First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Ocrelizumab Dose 1
Drug: Ocrelizumab Dose 2 and Dose 3
Enrollment 141
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion. This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Period Title: Overall Study
Started 95 46
Completed 94 38
Not Completed 1 8
Reason Not Completed
Lost to Follow-up             1             8
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion. This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours. Total of all reporting groups
Overall Number of Baseline Participants 95 46 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 46 participants 141 participants
41.75  (8.80) 41.07  (8.74) 41.52  (8.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 46 participants 141 participants
Female
59
  62.1%
34
  73.9%
93
  66.0%
Male
36
  37.9%
12
  26.1%
48
  34.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 46 participants 141 participants
Hispanic or Latino
4
   4.2%
3
   6.5%
7
   5.0%
Not Hispanic or Latino
88
  92.6%
41
  89.1%
129
  91.5%
Unknown
3
   3.2%
2
   4.3%
5
   3.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 46 participants 141 participants
Black or African American
8
   8.4%
8
  17.4%
16
  11.3%
White
86
  90.5%
35
  76.1%
121
  85.8%
Multiple
1
   1.1%
0
   0.0%
1
   0.7%
Unknown
0
   0.0%
3
   6.5%
3
   2.1%
1.Primary Outcome
Title Percentage of Participants With Infusion-related Reaction (IRR) Treated With 600 mg IV Ocrelizumab
Hide Description This outcome measure evaluates the occurrence of severe infusion-related reaction (IRR) with ocrelizumab 600 mg intravenously (IV) administered over the course of 2 hours. Rate and frequency of NCI CTCAE v4.0 Grade 3 and 4 IRRs
Time Frame During or within 24 hours of administration
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population was the same as the ITT population in this study. All enrolled participants received study treatment, hence treatment group comparability is not applicable. The analysis was conducted in Cohort 1.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who have already received one or two doses of ocrelizumab according to the approved infusion protocol and have reported no serious infusion-related reactions (IRRs) will be enrolled. They will then receive the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 is administered at Week 24, Dose 3 is administered at Week 48 after initial infusion.
Overall Number of Participants Analyzed 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0
(0.0 to 3.8)
2.Secondary Outcome
Title Percentage of Participants With IRRs
Hide Description This outcome measure evaluates the occurrence of overall IRRs with ocrelizumab either 300mg or 600mg IV infusion. Rate and frequency of NCI CTCAE v4.0 Grade 1-4 IRRs.
Time Frame During or within 24 hours of administration
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all enrolled participants who received any dose of study treatment, even if the infusion was incomplete. All enrolled participants received study treatment. The Safety population was the same as the ITT population in this study.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who have already received one or two doses of ocrelizumab according to the approved infusion protocol and have reported no serious infusion-related reactions (IRRs) will be enrolled. They will then receive the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 is administered at Week 24, Dose 3 is administered at Week 48 after initial infusion.
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Overall Number of Participants Analyzed 95 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
48.4
(38.0 to 58.9)
10.9
(3.6 to 23.6)
3.Secondary Outcome
Title Percentage of Participants With IRRs Treated With the 300 mg Shorter Dose of Ocrelizumab
Hide Description This outcome measure evaluate the occurrence of severe IRRs with ocrelizumab 300 mg administered over the course of 1.5 hours. Rate and frequency of NCI CTCAE v4.0 Grade 3-4 IRRs.
Time Frame During or within 24 hours of administration
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population was the same as the ITT population in this study. All enrolled participants received study treatment, hence treatment group comparability is not applicable. The analysis was conducted in Cohort 2.
Arm/Group Title Cohort 2
Hide Arm/Group Description:
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0
(0.0 to 7.7)
Time Frame 8 weeks
Adverse Event Reporting Description The Safety Population was defined as all enrolled participants who received any dose of study treatment, even if the infusion was incomplete. All enrolled participants received study treatment. The Safety population was the same as the ITT population in this study.
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description This cohort examined the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who had already received one or two doses of ocrelizumab according to the approved infusion protocol and had reported no serious infusion-related reactions (IRRs) were enrolled. They then received the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 was administered at Week 24, Dose 3 was administered at Week 48 after initial infusion. This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/95 (0.00%)      0/46 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/95 (0.00%)      0/46 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/95 (48.42%)      7/46 (15.22%)    
General disorders     
Fatigue  1  1/95 (1.05%)  1 3/46 (6.52%)  3
Injury, poisoning and procedural complications     
Infusion related reaction  1  46/95 (48.42%)  65 5/46 (10.87%)  7
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: NCT03606460    
Other Study ID Numbers: ML40638
First Submitted: July 23, 2018
First Posted: July 30, 2018
Results First Submitted: May 12, 2020
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020