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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390221
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE October 17, 2006
First Posted Date  ICMJE October 19, 2006
Results First Submitted Date May 31, 2016
Results First Posted Date July 11, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE February 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Adjusted Annualized Relapse Rate Between Baseline and Week 52 [ Time Frame: Baseline through Week 52 ]
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2006)
  • brain MRI measures (total number of gadolinium-enhancing lesions, number of new or newly-enlarging T2 hyperintense lesions, volume of new T1 hypointense lesions, and
  • the total lesion volume of new and newly enlarging T2 hyperintense lesions).
Change History Complete list of historical versions of study NCT00390221 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
  • Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24 [ Time Frame: Week 8 through Week 24 ]
    Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.
  • Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52 [ Time Frame: Week 52 ]
    Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.
  • Proportion of Participants Who Relapsed at Week 52 [ Time Frame: Week 52 ]
    Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.
  • Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52 [ Time Frame: Baseline and Week 52 ]
    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2006)
  • annualized relapse rate
  • time to first relapse
  • incidence of adverse events
  • incidence of development of antibodies to daclizumab
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
Official Title  ICMJE Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis
Intervention  ICMJE
  • Biological: BIIB019 (Daclizumab High Yield Process)
    SC injection
    Other Names:
    • DAC HYP
    • Daclizumab HYP
  • Drug: Placebo
    Placebo SC injection
Study Arms
  • Placebo Comparator: Placebo
    Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
    Intervention: Drug: Placebo
  • Experimental: 150 mg DAC HYP
    Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
  • Experimental: 300 mg DAC HYP
    Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2016)
Original Enrollment  ICMJE
 (submitted: October 18, 2006)
Actual Study Completion Date August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:

    • Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
    • Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
  • History of malignancy
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity
  • History of abnormal laboratory results based on investigator judgment
  • History of human immunodeficiency virus (HIV) or other immunodeficient conditions
  • History of drug or alcohol abuse within the 2 years prior to randomization
  • An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
  • Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
  • Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
  • Exposure to varicella zoster virus within 21 days before Screening.
  • Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10^9/L, Lymphocytes ≤1.0 × 10^9/L, Neutrophils ≤1.5 × 10^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Hungary,   India,   Poland,   Russian Federation,   Ukraine,   United Kingdom
Removed Location Countries Australia,   Former Serbia and Montenegro,   Sweden,   Turkey
Administrative Information
NCT Number  ICMJE NCT00390221
Other Study ID Numbers  ICMJE 205-MS-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP