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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 Idec
ClinicalTrials.gov Identifier:
NCT01064401
First received: January 26, 2010
Last updated: October 24, 2014
Last verified: October 2014

January 26, 2010
October 24, 2014
May 2010
March 2014   (final data collection date for primary outcome measure)
Annualized Relapse Rate(ARR) [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
Relapses are defined as new or recurrent neurological 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 ARR will be calculated as the total number of relapses experienced in the treatment group divided by the number of days in the study, and the ratio multiplied by 365.
The primary study objective is to test the superiority of DAC HYP compared to IFN β-1a in preventing MS relapse in subjects with relapsing remitting MS (RRMS). [ Time Frame: Designated Visits from Baseline Visit and every 4 weeks thereafter for up to 144 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01064401 on ClinicalTrials.gov Archive Site
  • Number of new or newly enlarging T2 hyperintense lesions on brain MRI [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)
  • Percentage of participants with sustained disability progression [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
    Sustained disability progression is defined as: at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from Baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
  • Percentage of participants who are relapse-free [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurological 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.
  • Percentage of participants with a ≥7.5 point worsening from baseline in the MSIS-29 physical score at 96 weeks [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
    The MSIS-29 is a 29-item 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 physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline.
The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this subject population. [ Time Frame: Designated Visits from Baseline Visit and every 4 weeks thereafter for up to 144 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Not Provided
Interventional
Phase 3
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)
    Daclizumab High Yield Process for subcutaneous injection
    Other Name: DAC HYP
  • Drug: Interferon beta-1a Placebo
    Placebo to interferon beta-1a intramuscular injection
  • Biological: Interferon beta-1a
    Interferon beta-1a for intramuscular injection
    Other Names:
    • Avonex
    • IFN β-1a
  • Drug: Daclizumab High Yield Process Placebo
    Placebo to Daclizumab High Yield Process subcutaneous injection
  • Experimental: Daclizumab High Yield Process 150 mg SC
    Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
    Interventions:
    • Biological: BIIB019 (Daclizumab High Yield Process)
    • Drug: Interferon beta-1a Placebo
  • Active Comparator: IFN β-1a 30 µg IM
    Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
    Interventions:
    • Biological: Interferon beta-1a
    • Drug: Daclizumab High Yield Process Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1841
July 2014
March 2014   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
  • Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
  • Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Key Exclusion Criteria:

  • Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
  • History of treatment with Daclizumab High Yield Process (Dac HYP)
  • History of malignancy
  • History of severe allergic or anaphylactic reactions
  • Known hypersensitivity to study drugs or their excipients
  • History of abnormal laboratory results indicative of any significant disease
  • History of human immunodeficiency virus (HIV) or other immunodeficient conditions
  • History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
  • History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
  • History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
  • 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
  • Known history of, or positive screening test result for hepatitis C virus or hepatitis B 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

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
United States,   Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Georgia,   Germany,   Greece,   Hungary,   India,   Ireland,   Israel,   Italy,   Mexico,   Moldova, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT01064401
205MS301, 2009-012500-11
Yes
Biogen Idec
Biogen Idec
AbbVie
Study Director: Medical Director Biogen Idec
Biogen Idec
October 2014

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