A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
PROTEC
A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting
2 other identifiers
interventional
1,114
10 countries
88
Brief Summary
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2013
Longer than P75 for phase_4
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedStudy Start
First participant enrolled
October 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2020
CompletedMarch 19, 2020
March 1, 2020
2.4 years
August 15, 2013
March 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Relapse Rate (ARR)
12 Months
Secondary Outcomes (16)
Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score
12 Months
Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score
12 Months
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score
12 Months
Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index
12 Months
Change from Baseline in participants-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score
12 Months
- +11 more secondary outcomes
Study Arms (1)
DMF
EXPERIMENTAL120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
Interventions
Administered as per the approved dosage in all countries where DMF has received marketing authorization.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) and satisfy the approved therapeutic indication for DMF (per the local DMF product information).
- 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.
You may not qualify if:
- Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (90)
Research Site
Innsbruck, 6020, Austria
Research Site
Klagenfurt, 9026, Austria
Research Site
Linz, 4020, Austria
Research Site
Salzburg, 5020, Austria
Research Site
Sankt Pölten, 3100, Austria
Research Site
Vienna, 1090, Austria
Research Site
Vienna, 1220, Austria
Research Site
Villach, 9500, Austria
Research Site
Bruges, 8000, Belgium
Research Site
Brussels, 1200, Belgium
Research Site
Melsbroek, 1820, Belgium
Research Site
Calgary, Alberta, T2N 2T9, Canada
Research Site
Victoria, British Columbia, V8R 1J6, Canada
Research Site
Saint John's, New Brunswick, E2K 5S9, Canada
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Research Site
Halifax, Nova Scotia, B3H 3A7, Canada
Research Site
London, Ontario, N6A 5A5, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Montreal, Quebec, H8A 2B4, Canada
Research Site
Brno, 625 00, Czechia
Research Site
Havířov, 736 00, Czechia
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Olomouc, 775 20, Czechia
Research Site
Pardubice, 532 03, Czechia
Research Site
Prague, 100 34, Czechia
Research Site
Prague, 128 08, Czechia
Research Site
Strasbourg, Bas Rhin, 67098, France
Research Site
Dijon, Cote dÝOr, 21079, France
Research Site
Besançon, Doubs, 25030, France
Research Site
Nîmes, Gard, 30029, France
Research Site
Bordeaux, Gironde, 33076, France
Research Site
Colmar, Haut Rhin, 68024, France
Research Site
Toulouse, Haute Garonne, 31059, France
Research Site
Limoges, Haute Vienne, 87042, France
Research Site
Rennes, Ille Et Vilaine, 35033, France
Research Site
Grenoble, Isere, 39043, France
Research Site
Nantes, Loire Atlantique, 44093, France
Research Site
Reims, Marne, 51092, France
Research Site
Lille, Nord, 59020, France
Research Site
Lille, Nord, 59037, France
Research Site
La Roche-sur-Yon, Vendee, 85025, France
Research Site
Poitiers, Vienne, 86021, France
Research Site
Le Chesnay, Yvelines, 78157, France
Research Site
Nancy, 54035, France
Research Site
Rouen, 76031, France
Research Site
Budapest, 1076, Hungary
Research Site
Budapest, 1083, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Pécs, 7623, Hungary
Research Site
Szeged, 6725, Hungary
Research Site
Veszprém, 8200, Hungary
Research Site
Ancona, 60126, Italy
Research Site
Bergamo, 24100, Italy
Research Site
Bolzano, 39100, Italy
Research Site
Castelfiorentino, 50051, Italy
Research Site
Florence, 50139, Italy
Research Site
Genova, 16153, Italy
Research Site
Messina, 98121, Italy
Research Site
Milan, 20133, Italy
Research Site
Napoli, 80131, Italy
Research Site
Perugia, 06156, Italy
Research Site
Pozzilli, 86077, Italy
Research Site
Roma, 00135, Italy
Research Site
Roma, 00189, Italy
Research Site
Siena, 53100, Italy
Research Site
Torino, 10124, Italy
Research Site
Almada, 2801-915, Portugal
Research Site
Amadora, 2720-276, Portugal
Research Site
Guimarães, 4835-044, Portugal
Research Site
Lisbon, 1169-050, Portugal
Research Site
Lisbon, 1649-035, Portugal
Research Site
Loures, 2674-514, Portugal
Research Site
Porto, 4099-001, Portugal
Research Site
Porto, 4200-319, Portugal
Research Site
Setúbal, 2910-446, Portugal
Research Site
Bratislava, 81369, Slovakia
Research Site
Prešov, 8081, Slovakia
Research Site
Ljubljana, SI-1525, Slovenia
Research Site
Maribor, 2000, Slovenia
Research Site
Majadahonda, Madrid, 28222, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Bilbao, 48013, Spain
Research Site
Córdoba, 14011, Spain
Research Site
El Palmar, 30120, Spain
Research Site
Girona, 17007, Spain
Research Site
Málaga, 29010, Spain
Research Site
Seville, 41009, Spain
Research Site
Valencia, 46026, Spain
Research Site
Vigo, 36204, Spain
Research Site
Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 31832225DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2013
First Posted
August 29, 2013
Study Start
October 31, 2013
Primary Completion
March 31, 2016
Study Completion
January 9, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03