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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01194570
Recruitment Status : Active, not recruiting
First Posted : September 3, 2010
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

  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
A total of 943 participants were screened and 732 were randomized into the study, of which 725 received at least one dose of placebo or ocrelizumab. A total of 549 participants were ongoing with double-blind treatment at the clinical cut-off date (CCOD).

Reporting Groups
  Description
Placebo Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Ocrelizumab 600 mg Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Participant Flow:   Overall Study
    Placebo   Ocrelizumab 600 mg
STARTED   244   488 
COMPLETED   0 [1]   0 
NOT COMPLETED   244   488 
Death                1                3 
Ongoing at CCOD                162                387 
Physician Decision                2                6 
Reason not specified                13                20 
Protocol Violation                0                2 
Non-compliance with study drug                2                2 
Adverse Event                12                18 
Non-compliance                2                2 
Lack of Efficacy                27                21 
Withdrawal by Subject                21                22 
Pregnancy                1                1 
Lost to Follow-up                1                4 
[1] Reason for discontinuation were provided for "Core Treatment Completion".



  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.
Analysis was performed on intent to treat (ITT) population which included all randomized participants in the study.

Reporting Groups
  Description
Placebo Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Ocrelizumab 600 mg Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ocrelizumab 600 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 244   488   732 
Age 
[Units: Years]
Mean (Standard Deviation) 		 44.4  (8.3)   44.7  (7.9)   44.6  (8.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      124  50.8%      237  48.6%      361  49.3% 
Male      120  49.2%      251  51.4%      371  50.7% 


  Outcome Measures

1.  Primary:   Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period   [ Time Frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm ]
  Show Outcome Measure 1

2.  Secondary:   Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period   [ Time Frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm ]
  Show Outcome Measure 2

3.  Secondary:   Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120   [ Time Frame: Baseline, Week 120 ]
  Show Outcome Measure 3

4.  Secondary:   Percent Change From Baseline in Total Volume of T2 Lesions at Week 120   [ Time Frame: From Baseline to Week 120 ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change in Total Brain Volume From Week 24 to Week 120   [ Time Frame: From Week 24 to Week 120 ]
  Show Outcome Measure 5

6.  Secondary:   Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120   [ Time Frame: From Baseline to Week 120 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With at Least One Adverse Event (AE)   [ Time Frame: From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks) ]
  Show Outcome Measure 7


  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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194570     History of Changes
Other Study ID Numbers: WA25046
2010-020338-25
First Submitted: August 28, 2010
First Posted: September 3, 2010
Results First Submitted: March 30, 2017
Results First Posted: December 26, 2017
Last Update Posted: December 26, 2017