Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2013
End Date:March 2016

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

A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a
12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated
with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The
secondary objectives of this study in this study population are to assess the impact of DMF
over a 12-month period on patient-reported outcomes (PROs) and health economic-related
outcomes and to evaluate additional clinical outcomes at Month 12.


Key Inclusion Criteria:

- Have the ability to understand the purpose and risks of the study and provide signed
and dated informed consent and authorization to use Protected Health Information in
accordance with national and local patient privacy regulations.

- Have the ability to read and understand written English.

- Have access to the internet and are able to complete online assessments on a computer

- Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic
indication for dimethyl fumarate (DMF) per the United States Prescribing Information
(USPI).

- Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer
acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g.,
suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment
with GA for relapsing forms of MS as a result of suboptimal response within 30 days
of enrollment.

- Have decided to initiate treatment with dimethyl fumarate (DMF) under routine
clinical care. The decision to initiate treatment with DMF must precede enrollment.

- Have a complete blood count (CBC) available within 6 months of initiation of
treatment with dimethyl fumarate (DMF).

Key Exclusion Criteria:

- Are unwilling or unable to comply with study requirements, or, are deemed unsuitable
for study participation at the discretion of the Prescribing Physician.

- Have major comorbid conditions that would preclude their participation in the study
as determined by the Prescribing Physician.

- Have a history of malignancy. (Patients with basal cell carcinoma that has been
completely excised prior to study entry remain eligible.)

- Have a history of and/or current serious infections.

- Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.

- Are receiving concomitant disease modifying therapies other than glatiramer acetate
(GA) or have initiated treatment with a new disease-modifying therapy since
discontinuation of glatiramer acetate (GA).

- Are currently enrolled in any other clinical studies, with the exception of the
dimethyl fumarate (DMF) Pregnancy Registry.

- Have received prior treatment with dimethyl fumarate (DMF).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
60
sites
2599
mi
from 02139
Medford, OR
Click here to add this to my saved trials
259
mi
from 02139
Abington, PA
Click here to add this to my saved trials
543
mi
from 02139
Akron, OH
Click here to add this to my saved trials
365
mi
from 02139
Annapolis, MD
Click here to add this to my saved trials
771
mi
from 02139
Asheville, NC
Click here to add this to my saved trials
934
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
357
mi
from 02139
Baltimore, MD
Click here to add this to my saved trials
1378
mi
from 02139
Baton Rouge, LA
Click here to add this to my saved trials
2475
mi
from 02139
Bellingham, WA
Click here to add this to my saved trials
1048
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
180
mi
from 02139
Bronx, NY
Click here to add this to my saved trials
543
mi
from 02139
Canton, OH
Click here to add this to my saved trials
706
mi
from 02139
Centerville, OH
Click here to add this to my saved trials
846
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Clinton Township, Michigan 48038
603
mi
from 02139
Clinton Township, MI
Click here to add this to my saved trials
1132
mi
from 02139
Columbia, MO
Click here to add this to my saved trials
639
mi
from 02139
Columbus, OH
Click here to add this to my saved trials
1154
mi
from 02139
Des Moines, IA
Click here to add this to my saved trials
320
mi
from 02139
Dover, DE
Click here to add this to my saved trials
1765
mi
from 02139
Englewood, CO
Click here to add this to my saved trials
847
mi
from 02139
Evanston, IL
Click here to add this to my saved trials
1003
mi
from 02139
Franklin, IL
Click here to add this to my saved trials
219
mi
from 02139
Freehold, NJ
Click here to add this to my saved trials
1124
mi
from 02139
Golden Valley, MN
Click here to add this to my saved trials
1975
mi
from 02139
Great Falls, MT
Click here to add this to my saved trials
460
mi
from 02139
Greensburg, PA
Click here to add this to my saved trials
712
mi
from 02139
Hickory, NC
Click here to add this to my saved trials
802
mi
from 02139
Indianapolis, IN
Click here to add this to my saved trials
1015
mi
from 02139
Jacksonville, FL
Click here to add this to my saved trials
815
mi
from 02139
Knoxville, TN
Click here to add this to my saved trials
1255
mi
from 02139
Lenexa, KS
Click here to add this to my saved trials
766
mi
from 02139
Lexington, KY
Click here to add this to my saved trials
8
mi
from 02139
Lexington, MA
Click here to add this to my saved trials
1222
mi
from 02139
Lighthouse Point, FL
Click here to add this to my saved trials
1322
mi
from 02139
Lincoln, NE
Click here to add this to my saved trials
2588
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
821
mi
from 02139
Louisville, KY
Click here to add this to my saved trials
769
mi
from 02139
Muskegon, MI
Click here to add this to my saved trials
880
mi
from 02139
Neenah, WI
Click here to add this to my saved trials
180
mi
from 02139
New York, NY
Click here to add this to my saved trials
469
mi
from 02139
Norfolk, VA
Click here to add this to my saved trials
1276
mi
from 02139
Omaha, NE
Click here to add this to my saved trials
148
mi
from 02139
Patchogue, NY
Click here to add this to my saved trials
479
mi
from 02139
Pittsburgh, PA
Click here to add this to my saved trials
1229
mi
from 02139
Port Charlotte, FL
Click here to add this to my saved trials
2530
mi
from 02139
Portland, OR
Click here to add this to my saved trials
608
mi
from 02139
Raleigh, NC
Click here to add this to my saved trials
469
mi
from 02139
Richmond, VA
Click here to add this to my saved trials
1680
mi
from 02139
Round Rock, TX
Click here to add this to my saved trials
2617
mi
from 02139
Sacramento, CA
Click here to add this to my saved trials
2091
mi
from 02139
Salt Lake City, UT
Click here to add this to my saved trials
2680
mi
from 02139
San Jose, CA
Click here to add this to my saved trials
902
mi
from 02139
Savannah, GA
Click here to add this to my saved trials
2481
mi
from 02139
Seattle, WA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
78
mi
from 02139
Springfield, MA
Click here to add this to my saved trials
1198
mi
from 02139
St. Petersburg, FL
Click here to add this to my saved trials
2493
mi
from 02139
Tacoma, WA
Click here to add this to my saved trials
1182
mi
from 02139
Tampa, FL
Click here to add this to my saved trials
2269
mi
from 02139
Tuscon, AZ
Click here to add this to my saved trials
36
mi
from 02139
Worcester, MA
Click here to add this to my saved trials