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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00906399




Registration number
NCT00906399
Ethics application status
Date submitted
20/05/2009
Date registered
20/05/2009
Date last updated
15/09/2014

Titles & IDs
Public title
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Scientific title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Secondary ID [1] 0 0
2008-006333-27
Secondary ID [2] 0 0
105MS301
Universal Trial Number (UTN)
Trial acronym
ADVANCE
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB017 (peginterferon beta-1a)
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.

Experimental: Peginterferon Beta-1a Q2W - 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.

Experimental: Peginterferon Beta-1a Q4W - 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).


Treatment: Drugs: BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.

Treatment: Drugs: Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Relapse Rate (ARR) at 1 Year - A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus = 4), baseline age (< 40 versus = 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
Timepoint [1] 0 0
1 Year
Secondary outcome [1] 0 0
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year - Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
Timepoint [1] 0 0
1 Year
Secondary outcome [2] 0 0
Proportion of Participants Relapsed at 1 Year - A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
Timepoint [2] 0 0
Year 1
Secondary outcome [3] 0 0
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year - Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS 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 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
Timepoint [3] 0 0
1 Year

Eligibility
Key inclusion criteria
Key

- Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by
McDonald criteria 1 through 4 (Polman, 2005)

- Must have an EDSS score between 0.0 and 5.0.

- Must have experienced at least 2 relapses that have been medically documented within
the last 3 years with at least one occurring in the last 12 months

Key
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other chronic disease of immune system, malignancies, urologic, pulmonary,
gastrointestinal disease

- Pregnant or nursing women

- Prior treatment with interferon could not exceed 4 weeks and subjects must have
discontinued interferon treatment 6 months prior to Baseline

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in
reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis
(RMS) at 1 year. The secondary objectives of this study are to determine whether
peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the
total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance
imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the
progression of disability.
Trial website
https://clinicaltrials.gov/show/NCT00906399
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 data has been provided for results reporting
Summary results
Other publications