Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01939002
• Date of registration: 23/08/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017) ALLOW
• Scientific 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
• Date of first enrolment: November 2013
• Target sample size: 251
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01939002
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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-ß and must be receiving a stable dose of IFN-ß 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 ß-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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: BIIB017

Drug: naproxen

Primary Outcome(s)

Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population [Time Frame: during the first 8 weeks of treatment]

Secondary Outcome(s)

Summary of Average Duration of FLS in the 48 Weeks of Treatment [Time Frame: 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 [Time Frame: 4-week run-in period, first 8 weeks of treatment]

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms [Time Frame: 4-week run-in period, Week 4]

Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population [Time Frame: Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination]

Antibody Data in the Overall Population: IFN ß-1a Anti-Pegylated (PEG) Antibody Testing [Time Frame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)]

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms [Time Frame: 4-week run-in period, Week 4]

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 [Time Frame: Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)]

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms [Time Frame: 4-week run-in period, Week 4]

Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms [Time Frame: 4-week run-in period, Week 4]

Antibody Data in the Overall Population: IFN ß-1a Antibody Screening [Time Frame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)]

Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment [Time Frame: 4-week run-in period, 48 weeks of treatment]

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population [Time Frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination]

Antibody Data in the Overall Population: IFN ß-1a Neutralizing Antibodies (Nabs) Testing [Time Frame: Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)]

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population [Time Frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)]

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population [Time Frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)]

Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs [Time Frame: Day 1 to Week 52]

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 [Time Frame: 4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment]

Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS [Time Frame: during the first 8 weeks of treatment]

Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms [Time Frame: during the first 8 weeks of treatment]

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population [Time Frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination]

Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment [Time Frame: 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 [Time Frame: 4-week run-in period, 48 weeks of treatment]

Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment [Time Frame: 4-week run-in period, 48 weeks of treatment]

Summary of Average Duration of FLS in the First 8 Weeks of Treatment [Time Frame: 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 the First 8 Weeks [Time Frame: 4-week run-in period, first 8 weeks of treatment]

Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms [Time Frame: 4-week run-in period, 48 weeks of treatment]

Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population [Time Frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)]

Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population [Time Frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)]

Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population [Time Frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination]

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 [Time Frame: 4-week run-in period, first 8 weeks of treatment]

Secondary ID(s)

105MS303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01939002