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
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on September 18, 2014