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Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis (SELECT)

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00390221
First received: October 17, 2006
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: 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
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Reporting Groups
  Description
Placebo Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
150 mg DAC HYP 150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
300 mg DAC HYP 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks

Participant Flow:   Overall Study
    Placebo     150 mg DAC HYP     300 mg DAC HYP  
STARTED     204     208     209  
COMPLETED     186     188     194  
NOT COMPLETED     18     20     15  
Lost to Follow-up                 0                 3                 0  
Adverse Event                 1                 4                 3  
Investigator Decision                 0                 0                 1  
Withdrawal by Subject                 13                 9                 7  
Subject Non-compliance                 1                 0                 2  
Not Specified                 3                 4                 2  



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
150 mg DAC HYP 150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
300 mg DAC HYP 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     150 mg DAC HYP     300 mg DAC HYP     Total  
Number of Participants  
[units: participants]
  204     208     209     621  
Age  
[units: years]
Mean (Standard Deviation)
  36.6  (9.02)     35.3  (8.94)     35.2  (8.67)     35.7  (8.88)  
Age, Customized  
[units: participants]
       
18 to 19 years     1     4     5     10  
20 to 29 years     46     55     53     154  
30 to 39 years     79     73     90     242  
40 to 49 years     60     67     49     176  
50 to 55 years     18     9     12     39  
Gender  
[units: participants]
       
Female     128     140     134     402  
Male     76     68     75     219  



  Outcome Measures
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1.  Primary:   Adjusted Annualized Relapse Rate Between Baseline and Week 52   [ Time Frame: Baseline through Week 52 ]

2.  Secondary:   Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24   [ Time Frame: Week 8 through Week 24 ]

3.  Secondary:   Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Proportion of Participants Who Relapsed at Week 52   [ Time Frame: Week 52 ]

5.  Secondary:   Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52   [ Time Frame: Baseline and Week 52 ]


  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: NCT00390221     History of Changes
Other Study ID Numbers: 205-MS-201
Study First Received: October 17, 2006
Results First Received: May 31, 2016
Last Updated: May 31, 2016
Health Authority: Ukraine: State Pharmacological Center - Ministry of Health
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation