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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01064401




Registration number
NCT01064401
Ethics application status
Date submitted
26/01/2010
Date registered
8/02/2010
Date last updated
11/07/2016

Titles & IDs
Public title
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Scientific 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 ß 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 0 0
2009-012500-11
Secondary ID [2] 0 0
205MS301
Universal Trial Number (UTN)
Trial acronym
(DECIDE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BIIB019 (Daclizumab High Yield Process)
Treatment: Drugs - Interferon beta-1a Placebo
Treatment: Other - Interferon beta-1a
Treatment: Drugs - Daclizumab High Yield Process Placebo

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 ß-1a intramuscular (IM) injection once weekly for 96 to 144 weeks

Active comparator: IFN ß-1a 30 µg IM - Interferon beta-1a (IFN ß-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks


Treatment: Other: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process for subcutaneous injection

Treatment: Drugs: Interferon beta-1a Placebo
Placebo to interferon beta-1a intramuscular injection

Treatment: Other: Interferon beta-1a
Interferon beta-1a for intramuscular injection

Treatment: Drugs: Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Up to 144 weeks
Secondary outcome [1] 0 0
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Timepoint [1] 0 0
up to 96 weeks
Secondary outcome [2] 0 0
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Timepoint [2] 0 0
Baseline through 144 weeks
Secondary outcome [3] 0 0
Proportion of Participants Relapse-free at Week 144
Timepoint [3] 0 0
144 weeks
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline and 96 weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
1841
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Auchenflower
Recruitment hospital [4] 0 0
Research Site - Woodville
Recruitment hospital [5] 0 0
Research Site - Fitzroy
Recruitment hospital [6] 0 0
Research Site - Heidelberg West
Recruitment postcode(s) [1] 0 0
- Camperdown
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- New Lambton Heights
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- Auchenflower
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- Woodville
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Heidelberg West
Recruitment outside Australia
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Salford
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01064401