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A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00676715
Recruitment Status : Active, not recruiting
First Posted : May 13, 2008
Results First Posted : May 11, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Drug: Placebo
Drug: Ocrelizumab
Drug: Avonex

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 220 participants were randomized, out of which 218 participants received study treatment.

Reporting Groups
  Description
Placebo Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 600 mg Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 1000 mg Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Avonex Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Participant Flow:   Overall Study
    Placebo   Ocrelizumab 600 mg   Ocrelizumab 1000 mg   Avonex
STARTED   54   55   55   54 
COMPLETED   14   8   14   14 
NOT COMPLETED   40   47   41   40 
Withdrawal by Subject                7                9                10                10 
Other                2                6                4                3 
Lost to Follow-up                1                1                7                3 
Death                1                1                1                0 
Adverse Event                0                1                2                0 
Participants Ongoing                29                29                17                24 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study drug and underwent at least one assessment of safety.

Reporting Groups
  Description
Placebo Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 600 mg Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 1000 mg Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Avonex Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ocrelizumab 600 mg   Ocrelizumab 1000 mg   Avonex   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 54   55   55   54   218 
Age 
[Units: Years]
Mean (Standard Deviation) 		 38.0  (8.8)   35.6  (8.5)   38.5  (8.7)   38.1  (9.3)   37.6  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		         
Female      36  66.7%      35  63.6%      38  69.1%      32  59.3%      141  64.7% 
Male      18  33.3%      20  36.4%      17  30.9%      22  40.7%      77  35.3% 


  Outcome Measures

1.  Primary:   Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain   [ Time Frame: Week 12 to Week 24 ]
  Show Outcome Measure 1

2.  Secondary:   Annualized Protocol Defined Relapse Rate at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Who Remained Relapse Free at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain   [ Time Frame: Weeks 4 to Week 24 ]
  Show Outcome Measure 5

6.  Secondary:   Total Number of Gadolinium-Enhancing T1 Lesions at Weeks   [ Time Frame: Weeks 4 to Week 24 ]
  Show Outcome Measure 6


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00676715     History of Changes
Other Study ID Numbers: ACT4422g
2007-006338-32 ( EudraCT Number )
WA21493 ( Other Identifier: Hoffmann-La Roche )
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: September 19, 2018