Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
ALLOW
An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017
1 other identifier
interventional
251
1 country
38
Brief Summary
The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score \[FLS-S\]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication \[TSQM\]) and disability status (measured with the Patient Determined Disease Steps \[PDDS\]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2013
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
January 25, 2017
CompletedJanuary 25, 2017
November 1, 2016
1.9 years
August 23, 2013
October 6, 2016
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population
The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.
during the first 8 weeks of treatment
Secondary Outcomes (30)
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms
during the first 8 weeks of treatment
Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment
4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment
Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks
4-week run-in period, first 8 weeks of treatment
Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks
4-week run-in period, 48 weeks of treatment
Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms
4-week run-in period, first 8 weeks of treatment
- +25 more secondary outcomes
Study Arms (2)
BIIB017 plus current FLS therapy
EXPERIMENTALFollowing a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
BIIB017 plus naproxen
EXPERIMENTALFollowing a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
Interventions
Eligibility Criteria
You may qualify if:
- Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 \[Polman 2005\]
- Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0
- Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening
- All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
You may not qualify if:
- Primary progressive, secondary progressive, or progressive relapsing MS \[Lublin and Reingold 1996\]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement
- History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol
- History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
- History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline
- Known allergy to any component of the BIIB017 formulation
- An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (38)
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Phoenix, Arizona, 85004, United States
Research Site
Phoenix, Arizona, 85018, United States
Research Site
Tucson, Arizona, 85704, United States
Research Site
Boulder, Colorado, 80301, United States
Research Site
Fort Collins, Colorado, 80528, United States
Research Site
Dover, Delaware, 19901, United States
Research Site
Newark, Delaware, 19713, United States
Research Site
Jacksonville, Florida, 32209, United States
Research Site
Melbourne, Florida, 32901, United States
Research Site
Tampa, Florida, 33609, United States
Research Site
Atlanta, Georgia, 30327, United States
Research Site
Kansas City, Kansas, 66160, United States
Research Site
Lexington, Kentucky, 40513, United States
Research Site
Louisville, Kentucky, 40207, United States
Research Site
Boston, Massachusetts, 02135, United States
Research Site
Lexington, Massachusetts, 02421, United States
Research Site
Worcester, Massachusetts, 01655, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Chesterfield, Missouri, 63017, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Great Falls, Montana, 59405, United States
Research Site
Lincoln, Nebraska, 68521, United States
Research Site
Latham, New York, 12110, United States
Research Site
Plainview, New York, 11803, United States
Research Site
Asheville, North Carolina, 28806, United States
Research Site
Akron, Ohio, 44320, United States
Research Site
Dayton, Ohio, 45417, United States
Research Site
Uniontown, Ohio, 44685, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Portland, Oregon, 97225, United States
Research Site
Greenville, South Carolina, 29607, United States
Research Site
Franklin, Tennessee, 37064, United States
Research Site
Knoxville, Tennessee, 37934, United States
Research Site
Salt Lake City, Utah, 84103, United States
Research Site
Newport News, Virginia, 23601, United States
Research Site
Roanoke, Virginia, 24018, United States
Research Site
Spokane, Washington, 99202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2013
First Posted
September 11, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
January 25, 2017
Results First Posted
January 25, 2017
Record last verified: 2016-11