Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis ((DECIDE))

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01064401
First received: January 26, 2010
Last updated: September 12, 2013
Last verified: June 2013

January 26, 2010
September 12, 2013
May 2010
March 2014   (final data collection date for primary outcome measure)
Annualized Relapse Rate [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
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 ]
  • Proportion of subjects with sustained disability progression defined by at least a 1.0-point increase 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 week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who are relapse-free [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with a ≥7.5 point worsening from baseline in the MSIS-29 physical score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
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 Daclizumab High Yield Process Versus Interferon β 1a in Patients 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 DAC HYP compared to IFN β-1a in preventing MS relapse in subjects 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 subject 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: Daclizumab High Yield Process (DAC HYP) (Active)
    Group 1: DAC HYP 150mg SC once every 4 weeks for 96 to 144 weeks
    Other Name: Daclizumab High Yield Process; DAC HYP
  • Drug: Interferon beta-1a Placebo
    Group 1: Placebo
  • Biological: Interferon beta-1a (IFN β-1a) (Active)
    Group 2: Interferon beta-1a 30 mcg Intramuscular injection once weekly for 96 to 144 weeks
    Other Names:
    • Avonex
    • IFN β-1a
  • Drug: Daclizumab High Yield Process Placebo
    Group 2: Placebo
  • Active Comparator: Group 1: Daclizumab High Yield Process 150 mg SC
    Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous injection once every 4 weeks for 96 to 144 weeks
    Interventions:
    • Biological: Daclizumab High Yield Process (DAC HYP) (Active)
    • Drug: Interferon beta-1a Placebo
  • Active Comparator: Group 2: IFN β-1a 30 mcg IM
    Interferon beta-1a (IFN β-1a) 30 mcg intramuscular injection once weekly for 96 to 144 weeks
    Interventions:
    • Biological: Interferon beta-1a (IFN β-1a) (Active)
    • 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.
 
Active, not recruiting
1800
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis, and a cranial MRI demonstrating lesion(s) consistent with MS
  • Must have a baseline 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

Exclusion Criteria:

  • Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg
  • History of treatment with 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
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 (Medical Director), Biogen Idec
Biogen Idec
AbbVie
Not Provided
Biogen Idec
June 2013

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