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
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Biological: Daclizumab High Yield Process (DAC HYP) (Active)
Drug: Interferon beta-1a Placebo
Biological: Interferon beta-1a (IFN β-1a) (Active)
Drug: Daclizumab High Yield Process Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1800
Study Start Date: May 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064401

  Show 225 Study Locations
Sponsors and Collaborators
Biogen Idec
AbbVie
  More Information

No publications provided

Responsible Party: Biogen Idec (Medical Director), Biogen Idec
ClinicalTrials.gov Identifier: NCT01064401     History of Changes
Other Study ID Numbers: 205MS301, 2009-012500-11
Study First Received: January 26, 2010
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Daclizumab
Immunoglobulin G
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 22, 2014