Clinical trial NCT01939002: Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: flu-like symptoms
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

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

Primary outcomes:
measure: Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population
timeFrame: during the first 8 weeks of treatment
Secondary outcomes:
measure: Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms
timeFrame: during the first 8 weeks of treatment
measure: 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
timeFrame: 4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment
measure: Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks
timeFrame: 4-week run-in period, first 8 weeks of treatment
measure: Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks
timeFrame: 4-week run-in period, 48 weeks of treatment
measure: Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms
timeFrame: 4-week run-in period, first 8 weeks of treatment
measure: Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms
timeFrame: 4-week run-in period, 48 weeks of treatment
measure: Summary of Average Duration of FLS in the First 8 Weeks of Treatment
timeFrame: 4-week run-in period, first 8 weeks of treatment
measure: Summary of Average Duration of FLS in the 48 Weeks of Treatment
timeFrame: 4-week run-in period, 48 weeks of treatment
measure: Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
timeFrame: 4-week run-in period, first 8 weeks of treatment
measure: Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
timeFrame: 4-week run-in period, first 8 weeks of treatment
measure: Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
timeFrame: 4-week run-in period, 48 weeks of treatment
measure: Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
timeFrame: 4-week run-in period, 48 weeks of treatment
measure: Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS
timeFrame: during the first 8 weeks of treatment
measure: Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population
timeFrame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
measure: Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population
timeFrame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
measure: Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population
timeFrame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
measure: Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population
timeFrame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
measure: Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms
timeFrame: 4-week run-in period, Week 4
measure: Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms
timeFrame: 4-week run-in period, Week 4
measure: Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms
timeFrame: 4-week run-in period, Week 4
measure: Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms
timeFrame: 4-week run-in period, Week 4
measure: Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population
timeFrame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
measure: Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population
timeFrame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
measure: Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population
timeFrame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
measure: Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population
timeFrame: Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination
measure: Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
timeFrame: Day 1 to Week 52
measure: Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period
timeFrame: Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)
measure: Antibody Data in the Overall Population: IFN β-1a Antibody Screening
timeFrame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
measure: Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing
timeFrame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
measure: Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing
timeFrame: Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: Fort Collins
country: United States
facility: Research Site
state: Colorado
city: Dover
country: United States
facility: Research Site
state: Delaware
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Melbourne
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Lexington
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Great Falls
country: United States
facility: Research Site
state: Montana
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Latham
country: United States
facility: Research Site
state: New York
city: Plainview
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Uniontown
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: