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Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE))

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01064401
First received: January 26, 2010
Last updated: May 31, 2016
Last verified: May 2016
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
Interventions: Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Interferon beta-1a Placebo
Biological: Interferon beta-1a
Drug: Daclizumab High Yield Process 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Interferon Beta-1a Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
Daclizumab High Yield Process DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks

Participant Flow:   Overall Study
    Interferon Beta-1a     Daclizumab High Yield Process  
STARTED     922     919  
COMPLETED     694     724  
NOT COMPLETED     228     195  
Adverse Event                 47                 56  
Lack of Efficacy                 46                 23  
Lost to Follow-up                 12                 9  
Consent Withdrawn                 98                 80  
Investigator Decision                 4                 6  
Death                 4                 0  
Pregnancy                 4                 7  
Noncompliance                 7                 8  
Site Closure                 4                 5  
Not Specified                 2                 1  



  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.
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Reporting Groups
  Description
Interferon Beta-1a IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
Daclizumab High Yield Process DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
Total Total of all reporting groups

Baseline Measures
    Interferon Beta-1a     Daclizumab High Yield Process     Total  
Number of Participants  
[units: participants]
  922     919     1841  
Age  
[units: years]
Mean (Standard Deviation)
  36.2  (9.32)     36.4  (9.36)     36.3  (9.34)  
Age, Customized  
[units: participants]
     
18 to 19 years     25     14     39  
20 to 29 years     227     236     463  
30 to 39 years     327     322     649  
40 to 49 years     256     250     506  
50 to 55 years     86     96     182  
> 55 years     1     1     2  
Gender  
[units: participants]
     
Female     627     625     1252  
Male     295     294     589  



  Outcome Measures
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1.  Primary:   Adjusted Annualized Relapse Rate (ARR)   [ Time Frame: Up to 144 weeks ]

2.  Secondary:   Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96   [ Time Frame: up to 96 weeks ]

3.  Secondary:   Proportion of Participants With Sustained Disability Progression at 144 Weeks   [ Time Frame: Baseline through 144 weeks ]

4.  Secondary:   Proportion of Participants Relapse-free at Week 144   [ Time Frame: 144 weeks ]

5.  Secondary:   Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks   [ Time Frame: Baseline and 96 weeks ]


  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
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  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: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com


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

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01064401     History of Changes
Other Study ID Numbers: 205MS301
2009-012500-11
Study First Received: January 26, 2010
Results First Received: May 31, 2016
Last Updated: May 31, 2016
Health Authority: United States: Food and Drug Administration