Characterize Flu-like Symptoms in RRMS Patients Transitioning From IFN-B Therapies to Peginterferon Beta-1a
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/12/2016 |
Start Date: | November 2013 |
End Date: | November 2015 |
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
The primary objective of this study is to determine the proportion of relapsing multiple
sclerosis (RMS) participants who experience new and/or increased flu-like symptoms (FLS)
after transitioning from nonpegylated interferon beta (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 effectiveness and
participants' satisfaction with FLS management as measured by an FLS visual analog scale
(FLS-VAS); To determine the effect of peginterferon beta-1a on other participant reported
outcomes (PROs) 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 peginterferon beta-1a -related FLS; to determine the incidence of
adverse events (AEs) throughout the study period; to characterize the immunogenicity
profiles of participants switching from prior IFN-β (interferon beta) therapy to
peginterferon beta-1a.
sclerosis (RMS) participants who experience new and/or increased flu-like symptoms (FLS)
after transitioning from nonpegylated interferon beta (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 effectiveness and
participants' satisfaction with FLS management as measured by an FLS visual analog scale
(FLS-VAS); To determine the effect of peginterferon beta-1a on other participant reported
outcomes (PROs) 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 peginterferon beta-1a -related FLS; to determine the incidence of
adverse events (AEs) throughout the study period; to characterize the immunogenicity
profiles of participants switching from prior IFN-β (interferon beta) therapy to
peginterferon beta-1a.
Key Inclusion Criteria:
- Must have a confirmed diagnosis of relapsing forms of MS, as defined by McDonald
criteria #1-4 [Polman 2005].
- Must have neurological findings consistent with an 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 interferon beta-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 peginterferon beta-1a 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.
We found this trial at
37
sites
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