Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis (ADVANCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00906399
First received: May 20, 2009
Last updated: April 4, 2014
Last verified: April 2014

May 20, 2009
April 4, 2014
June 2009
October 2012   (final data collection date for primary outcome measure)
Annualized Relapse Rate (ARR). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
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 neurological findings. The relapse rate for each treatment group will be calculated as the total number of relapses experienced in the group divided by the total number of days in the study for the group, and the ratio multiplied by 365.
To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00906399 on ClinicalTrials.gov Archive Site
  • The number of new or newly enlarging T2 hyperintense lesions on brain MRI scans [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number of participants with relapses [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Time to sustained progression of disability [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Sustained disability progression is defined as: at least a 1.0 point increase on the Expanded Disability Status Scale (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 multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS
To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. [ Time Frame: 1 year +2 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis
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

The primary objective of this study is to determine the efficacy of BIIB017 (PEGylated Interferon Beta-1a) in reducing the Annualized Relapse Rate (ARR) in participants with RMS at 1 year. The secondary objectives of this study are to determine, whether efficacy PEGylated Interferon 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 MRI scans, reducing the proportion of participants who relapsed and slowing the progression of disability.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Drug: BIIB017 (PEGylated Interferon 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.
    Other Names:
    • PEG IFN ß-1a
    • PEGylated Interferon beta-1a
    • BIIB017
  • Drug: Placebo
    Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
  • Placebo Comparator: Placebo
    Placebo every 2 weeks for 48 weeks followed by 125 µg PEGylated Interferon Beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
    Interventions:
    • Drug: BIIB017 (PEGylated Interferon Beta-1a)
    • Drug: Placebo
  • Experimental: BIIB017 Q2W
    125 µg PEGylated Interferon Beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
    Intervention: Drug: BIIB017 (PEGylated Interferon Beta-1a)
  • Experimental: BIIB017 Q4W
    125 µg PEGylated Interferon Beta-1a subcutaneously every 4 weeks (Q4W) and placebo every other 4 weeks for 96 weeks.
    Interventions:
    • Drug: BIIB017 (PEGylated Interferon Beta-1a)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1516
October 2013
October 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), as defined by McDonald criteria #1-4
  • Must have an Expanded Disability Status Scale (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 one occurring in the last 12 months

Key Exclusion Criteria:

  • Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
  • Pregnant or nursing women

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00906399
105MS301, 2008-006333-27
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP