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Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis (SELECTION)

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00870740
First received: March 26, 2009
Last updated: July 19, 2016
Last verified: July 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
No text entered.

Reporting Groups
  Description
Placebo + DAC HYP 150 mg Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Placebo + DAC HYP 300 mg Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
DAC HYP 150 mg + Washout Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
DAC HYP 150 mg for 2 Years Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
DAC HYP 300 mg + Washout Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
DAC HYP 300 mg for 2 Years Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.

Participant Flow:   Overall Study
    Placebo + DAC HYP 150 mg   Placebo + DAC HYP 300 mg   DAC HYP 150 mg + Washout   DAC HYP 150 mg for 2 Years   DAC HYP 300 mg + Washout   DAC HYP 300 mg for 2 Years
STARTED   86 [1]   84 [1]   86 [1]   86 [1]   88 [1]   87 [1] 
COMPLETED   74   75   76   74   77   70 
NOT COMPLETED   12   9   10   12   11   17 
Adverse Event                2                1                3                2                1                6 
Consent Withdrawn                6                3                4                6                6                5 
Investigator Decision                2                0                1                0                0                0 
Subject Non-compliance                0                0                0                0                0                1 
Death                0                0                0                0                1                0 
Not Specified                2                5                2                4                3                5 
[1] number randomized and dosed



  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 + DAC HYP 150 mg Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Placebo + DAC HYP 300 mg Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
DAC HYP 150 mg + Washout Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
DAC HYP 150 mg for 2 Years Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
DAC HYP 300 mg + Washout Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
DAC HYP 300 mg for 2 Years Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Total Total of all reporting groups

Baseline Measures
   Placebo + DAC HYP 150 mg   Placebo + DAC HYP 300 mg   DAC HYP 150 mg + Washout   DAC HYP 150 mg for 2 Years   DAC HYP 300 mg + Washout   DAC HYP 300 mg for 2 Years   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   84   86   86   88   87   517 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.2  (9.78)   37.8  (7.98)   36.8  (8.76)   36.2  (9.30)   36.2  (9.03)   36.0  (7.60)   36.9  (8.77) 
Age, Customized 
[Units: Participants]
             
18 to 19 years   0   0   0   0   1   1   2 
20 to 29 years   19   13   19   25   20   16   112 
30 to 39 years   26   37   29   28   35   41   196 
40 to 49 years   29   28   33   27   24   25   166 
50 to 55 years   11   6   5   6   7   3   38 
> 55 years   1   0   0   0   1   1   3 
Gender 
[Units: Participants]
             
Female   53   54   59   53   59   48   326 
Male   33   30   27   33   29   39   191 


  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-emergent Adverse Events (AEs)   [ Time Frame: Up to 72 weeks ]

2.  Primary:   Number of Participants With Abnormalities in Vital Signs   [ Time Frame: Up to Week 72 ]

3.  Primary:   Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities   [ Time Frame: Up to 72 Weeks ]

4.  Primary:   Number of Participants With Abnormalities in Blood Chemistry Laboratory Data   [ Time Frame: Up to 72 Weeks ]

5.  Primary:   Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline   [ Time Frame: Up to 72 weeks ]

6.  Secondary:   Adjusted Annualized Relapse Rate   [ Time Frame: Up to 72 weeks ]

7.  Secondary:   Estimated Proportion of Participants With a Relapse   [ Time Frame: Up to 72 weeks ]

8.  Secondary:   Mean Number of New Gadolinium-enhancing Lesions   [ Time Frame: Week 20, Week 52 ]

9.  Secondary:   Mean Number of New or Newly-enlarging T2 Hyperintense Lesions   [ Time Frame: Baseline, Week 20, Week 52 ]

10.  Secondary:   Mean Volume of New T1 Hypointense Lesions   [ Time Frame: Baseline, Week 20, Week 52 ]

11.  Secondary:   Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions   [ Time Frame: Baseline, Week 52 ]

12.  Secondary:   Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions   [ Time Frame: Baseline, Week 52 ]

13.  Secondary:   Rate of Percentage Change From Baseline in Mean Total Brain Volume   [ Time Frame: Baseline, 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: NCT00870740     History of Changes
Other Study ID Numbers: 205-MS-202
EUDRA CT No.: 2008-005559-46
Study First Received: March 26, 2009
Results First Received: May 31, 2016
Last Updated: July 19, 2016
Health Authority: Ukraine: State Expert Centre of the Ministry of Health of Ukraine
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
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation