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
ClinicalTrials.gov Identifier:
NCT01064401
First received: January 26, 2010
Last updated: May 31, 2016
Last verified: May 2016

January 26, 2010
May 31, 2016
May 2010
March 2014   (final data collection date for primary outcome measure)
Adjusted 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. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.
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
  • Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96 [ Time Frame: up to 96 weeks ] [ Designated as safety issue: No ]
    The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.
  • Proportion of Participants With Sustained Disability Progression at 144 Weeks [ Time Frame: Baseline through 144 weeks ] [ Designated as safety issue: No ]
    Sustained disability progression is defined as: at least a 1.0-point increase on the 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 MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.
  • Proportion of Participants Relapse-free at Week 144 [ Time Frame: 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. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.
  • Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact 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. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.
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
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.

*   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   (Adult)
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
Bulgaria,   Egypt,   Slovenia
 
NCT01064401
205MS301, 2009-012500-11
Yes
Not Provided
Not Provided
Biogen
Biogen
AbbVie
Study Director: Medical Director Biogen
Biogen
May 2016

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