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

Use our guide to learn which trials are right for you!

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.


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
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boulder, CO
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dover, DE
Click here to add this to my saved trials
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Latham, NY
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lexington, MA
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plainview, NY
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Uniontown, OH
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials