A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
NCT ID: NCT01930708
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1114 participants
INTERVENTIONAL
2013-10-31
2020-01-09
Brief Summary
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The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DMF
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
dimethyl fumarate
Administered as per the approved dosage in all countries where DMF has received marketing authorization.
Interventions
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dimethyl fumarate
Administered as per the approved dosage in all countries where DMF has received marketing authorization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.
* Have a recent complete blood count (CBC) that does not preclude the subject's participation in the study, in the judgment of the Investigator.
Exclusion Criteria
* Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
* Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.
* Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.
* Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.
* Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS.
* Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.
* Current enrollment in any clinical trial except for the Biogen Idec DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Innsbruck, , Austria
Research Site
Klagenfurt, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Villach, , Austria
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Bruges, , Belgium
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Brussels, , Belgium
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Melsbroek, , Belgium
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Calgary, Alberta, Canada
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Victoria, British Columbia, Canada
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Saint John's, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Havířov, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Strasbourg, Bas Rhin, France
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Dijon, Cote dÝOr, France
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Besançon, Doubs, France
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Nîmes, Gard, France
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Bordeaux, Gironde, France
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Colmar, Haut Rhin, France
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Toulouse, Haute Garonne, France
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Limoges, Haute Vienne, France
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Rennes, Ille Et Vilaine, France
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Grenoble, Isere, France
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Nantes, Loire Atlantique, France
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Reims, Marne, France
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Lille, Nord, France
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Lille, Nord, France
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La Roche-sur-Yon, Vendee, France
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Poitiers, Vienne, France
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Le Chesnay, Yvelines, France
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Nancy, , France
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Rouen, , France
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Veszprém, , Hungary
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Ancona, , Italy
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Bergamo, , Italy
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Bolzano, , Italy
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Castelfiorentino, , Italy
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Florence, , Italy
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Genova, , Italy
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Messina, , Italy
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Milan, , Italy
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Napoli, , Italy
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Perugia, , Italy
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Pozzilli, , Italy
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Roma, , Italy
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Roma, , Italy
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Siena, , Italy
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Torino, , Italy
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Almada, , Portugal
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Amadora, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Loures, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Setúbal, , Portugal
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Bratislava, , Slovakia
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Prešov, , Slovakia
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Ljubljana, , Slovenia
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Maribor, , Slovenia
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Majadahonda, Madrid, Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Córdoba, , Spain
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El Palmar, , Spain
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Girona, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
Research Site
Vigo, , Spain
Research Site
Zaragoza, , Spain
Countries
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References
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Berger T, Brochet B, Brambilla L, Giacomini PS, Montalban X, Vasco Salgado A, Su R, Bretagne A. Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. Mult Scler J Exp Transl Clin. 2019 Dec 2;5(4):2055217319887191. doi: 10.1177/2055217319887191. eCollection 2019 Oct-Dec.
Other Identifiers
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2013-001656-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
109MS408
Identifier Type: -
Identifier Source: org_study_id
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