Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Biogen Idec
Collaborator:	Abbott Biotherapeutics Corp.
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT01064401

Purpose

The existing scientific and clinical experience with DAC HYP supports its further investigation in the management of multiple sclerosis (MS). This study is being conducted to determine the superiority of DAC HYP compared to IFN β-1a in preventing MS relapse in subjects with relapsing remitting MS (RRMS) when DAC HYP 150mg is administered SC once every 4 weeks for 96 to 144 weeks as compared to a 30mg IM injection of Interferon β1a once weekly for 96 to 144 weeks.

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Interferon β 1a Drug: DAC HYP	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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon beta-1a Daclizumab Rebif

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1800
Study Start Date:	March 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: DAC HYP 150mg SC once every 4 weeks for 96 to 144 weeks	Drug: DAC HYP DAC HYP 150mg SC once every 4 weeks for 96 to 144 weeks Other Names: Dac HYP Daclizumab High Yield
Active Comparator: Interferonβ1a 30mcgIMinjection once weekly for 96 to 144 weeks	Drug: Interferon β 1a Interferon β 1a 30mcg IM injection once weekly for 96 to 144 weeks Other Name: Avonex

Eligibility

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

Criteria

Inclusion Criteria:

Must be 18 to 55 years of age, inclusive, at the time of consent
Must have a confirmed diagnosis of RRMS, 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

Contacts

Contact: MD Decide Study

decidestudy@biogenidec.com

Show 218 Study Locations

Sponsors and Collaborators

Biogen Idec

Abbott Biotherapeutics Corp.

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:	March 22, 2012
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 1a

Interferons
Daclizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2012