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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: March 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Multiple Sclerosis
Interventions: Drug: Interferon beta-1a
Drug: Ocrelizumab-matching placebo
Drug: Ocrelizumab
Drug: Interferon beta-1a-matching placebo

  Participant Flow
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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 1045 participants were screened for entry into the study. Of these, 210 participants failed screening; the main reasons were failure to meet the inclusion/exclusion criteria or unacceptable laboratory values. A total of 835 participants were enrolled in the study.

Reporting Groups
  Description
Interferon Beta-1a 44 mcg SC Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Ocrelizumab Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.

Participant Flow:   Overall Study
    Interferon Beta-1a 44 mcg SC   Ocrelizumab
STARTED   418   417 
COMPLETED   320   360 
NOT COMPLETED   98   57 
Death                1                1 
Physician Decision                0                1 
Reason not specified                16                10 
Non-compliance with study drug                1                1 
Protocol Violation                1                1 
Non-compliance                1                3 
Lack of Efficacy                15                6 
Pregnancy                3                0 
Consent withdrawn by participant                25                12 
Adverse Event                25                16 
Lost to Follow-up                10                6 



  Baseline Characteristics
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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.
Intent-to-treat (ITT) population included all randomized participants in the study.

Reporting Groups
  Description
Interferon Beta-1a 44 mcg SC Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Ocrelizumab Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Total Total of all reporting groups

Baseline Measures
   Interferon Beta-1a 44 mcg SC   Ocrelizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 418   417   835 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.4  (9.0)   37.2  (9.1)   37.3  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      280  67.0%      271  65.0%      551  66.0% 
Male      138  33.0%      146  35.0%      284  34.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks   [ Time Frame: Week 96 ]

2.  Secondary:   Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period   [ Time Frame: Week 104 ]

3.  Secondary:   Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment   [ Time Frame: Baseline up to week 96 ]

4.  Secondary:   Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment   [ Time Frame: Baseline up to week 96 ]

5.  Secondary:   Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks   [ Time Frame: Week 96 ]

6.  Secondary:   Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period   [ Time Frame: Week 104 ]

7.  Secondary:   Number of T1 Hypointense Lesions During the Double-Blind Treatment   [ Time Frame: Baseline up to week 96 ]

8.  Secondary:   Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96   [ Time Frame: Baseline, Week 96 ]

9.  Secondary:   Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96   [ Time Frame: From week 24 up to week 96 ]

10.  Secondary:   Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96   [ Time Frame: Baseline, Week 96 ]

11.  Secondary:   Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96   [ Time Frame: Week 96 ]

12.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline up to Week 96 ]

13.  Secondary:   Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)   [ Time Frame: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96 ]

14.  Secondary:   Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab   [ Time Frame: Baseline up to Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT01412333     History of Changes
Other Study ID Numbers: WA21093
2010-020315-36 ( EudraCT Number )
Study First Received: August 8, 2011
Results First Received: March 30, 2017
Last Updated: July 17, 2017