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 Idec
ClinicalTrials.gov Identifier:
NCT00390221
First received: October 17, 2006
Last updated: September 25, 2014
Last verified: September 2014

October 17, 2006
September 25, 2014
February 2008
May 2011   (final data collection date for primary outcome measure)
Annualized Relapse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 will be calculated as the total number of relapses experienced in the group divided by the number of days up to Week 52, and the ratio multiplied by 365.
  • the total lesion volume of new and newly enlarging T2 hyperintense lesions).
  • 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
Complete list of historical versions of study NCT00390221 on ClinicalTrials.gov Archive Site
  • Number of new Gd-enhancing lesions [ Time Frame: Weeks 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of participants with relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 physical score [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.
  • Number of new or newly-enlarging T2 hyperintense lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • annualized relapse rate
  • time to first relapse
  • incidence of adverse events
  • incidence of development of antibodies to daclizumab
Not Provided
Not Provided
 
Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
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

The primary objective of this study is to determine whether Daclizumab High Yield Process, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether Daclizumab High Yield Process 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 relapses and improving quality of life.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Biological: BIIB019 (Daclizumab High Yield Process)
    SC injection
    Other Names:
    • DAC HYP
    • BIIB019
    • Daclizumab HYP
  • Drug: Placebo
    Placebo SC injection
  • 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)
Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
August 2011
May 2011   (final data collection date for primary outcome measure)

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
  • 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 × 109/L, Lymphocytes ≤1.0 × 109/L, Neutrophils ≤1.5 × 109/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.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Russian Federation,   Czech Republic,   Germany,   Hungary,   India,   United Kingdom,   Ukraine
 
NCT00390221
205-MS-201
Yes
Biogen Idec
Biogen Idec
AbbVie
Study Director: Medical Director Biogen Idec
Biogen Idec
September 2014

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