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A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
dimethyl fumarate
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring BG-12

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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).

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DMF

Arm Description

120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR)

Secondary Outcome Measures

Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score
This is a validated, 29-item, MS-specific HRQoL scale that measures the physical (20 items) and psychological (9 items) impact of MS on the participant's day-to-day life during the previous 2 weeks. For each item, the subject is asked to circle the number that best describes his or her situation. The numbers for each item range from 1 (not at all) to 5 (extremely).
Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score
This scale consists of 5 statements that describe how fatigue may affect a person. For each statement, the participant is asked to circle the number that best indicates how often fatigue has affected him or her during the previous 4 weeks. The numbers for each question range from 0 (never) to 4 (almost always).
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score
This is a validated, 14-item questionnaire that measures a participant's level of satisfaction/dissatisfaction with medication.
Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index
The widely validated EQ-5D includes 2 components, the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the subject is instructed to indicate whether he or she has "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems (level 4), or "extreme problems/inability" (level 5) on that day. For the EQ VAS, the participant is instructed to mark an "x" on a vertical scale at the point that best describes his or her own health on that day, where 0 represents the "worst health" he or she can imagine and 100 the "best health" he or she can imagine.
Change from Baseline in participants-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score
This 15-item component of the PRIMUS assesses a participant's ability to carry out various activities of daily living during the previous week without the use of aids (e.g., cane, walker, or wheelchair) or assistance. For each item, the participant is asked whether he or she can perform the activity without difficulty or with difficulty, or is unable to perform the activity.
Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score
This 6-item instrument assesses employment status, and, during the previous 7 days, hours of missed work due to MS or other reasons, hours worked (if employed), effect on productivity due to MS while working, and activity impairment attributable to health problems.
Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score
This is a 7-item scale that evaluates depression in participants with medical illness during the prior 2 weeks. It has been validated in subjects with MS.
Proportion of participants with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6
The proportion of participants relapsed
Number of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS
Proportion of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS
Proportion of participants who report taking the prescribed DMF dose
Percentage of participants who report taking the prescribed DMF dose
Reasons reported by participants for not taking prescribed DMF dose
Change from baseline in EQ Visual Analog Scale (EQVAS) score
A component of the EQ-5D, where participants are asked to rate their overall health-related quality of life on a standard vertical 20 cm visual analogue scale (similar to a thermometer) between 100 (best health imaginable) and 0 (worst health imaginable).

Full Information

First Posted
August 15, 2013
Last Updated
March 18, 2020
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01930708
Brief Title
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
Acronym
PROTEC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2013 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
January 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Keywords
BG-12

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMF
Arm Type
Experimental
Arm Description
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
Tecfidera, DMF, BG00012
Intervention Description
Administered as per the approved dosage in all countries where DMF has received marketing authorization.
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score
Description
This is a validated, 29-item, MS-specific HRQoL scale that measures the physical (20 items) and psychological (9 items) impact of MS on the participant's day-to-day life during the previous 2 weeks. For each item, the subject is asked to circle the number that best describes his or her situation. The numbers for each item range from 1 (not at all) to 5 (extremely).
Time Frame
12 Months
Title
Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score
Description
This scale consists of 5 statements that describe how fatigue may affect a person. For each statement, the participant is asked to circle the number that best indicates how often fatigue has affected him or her during the previous 4 weeks. The numbers for each question range from 0 (never) to 4 (almost always).
Time Frame
12 Months
Title
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score
Description
This is a validated, 14-item questionnaire that measures a participant's level of satisfaction/dissatisfaction with medication.
Time Frame
12 Months
Title
Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index
Description
The widely validated EQ-5D includes 2 components, the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the subject is instructed to indicate whether he or she has "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems (level 4), or "extreme problems/inability" (level 5) on that day. For the EQ VAS, the participant is instructed to mark an "x" on a vertical scale at the point that best describes his or her own health on that day, where 0 represents the "worst health" he or she can imagine and 100 the "best health" he or she can imagine.
Time Frame
12 Months
Title
Change from Baseline in participants-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score
Description
This 15-item component of the PRIMUS assesses a participant's ability to carry out various activities of daily living during the previous week without the use of aids (e.g., cane, walker, or wheelchair) or assistance. For each item, the participant is asked whether he or she can perform the activity without difficulty or with difficulty, or is unable to perform the activity.
Time Frame
12 Months
Title
Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score
Description
This 6-item instrument assesses employment status, and, during the previous 7 days, hours of missed work due to MS or other reasons, hours worked (if employed), effect on productivity due to MS while working, and activity impairment attributable to health problems.
Time Frame
12 Months
Title
Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score
Description
This is a 7-item scale that evaluates depression in participants with medical illness during the prior 2 weeks. It has been validated in subjects with MS.
Time Frame
12 Months
Title
Proportion of participants with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression
Description
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Time Frame
12 Months
Title
Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6
Time Frame
Baseline, 6 Months
Title
The proportion of participants relapsed
Time Frame
12 Months
Title
Number of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS
Time Frame
12 Months
Title
Proportion of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS
Time Frame
12 Months
Title
Proportion of participants who report taking the prescribed DMF dose
Time Frame
12 Months
Title
Percentage of participants who report taking the prescribed DMF dose
Time Frame
12 Months
Title
Reasons reported by participants for not taking prescribed DMF dose
Time Frame
12 Months
Title
Change from baseline in EQ Visual Analog Scale (EQVAS) score
Description
A component of the EQ-5D, where participants are asked to rate their overall health-related quality of life on a standard vertical 20 cm visual analogue scale (similar to a thermometer) between 100 (best health imaginable) and 0 (worst health imaginable).
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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). Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Klagenfurt
ZIP/Postal Code
9026
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Research Site
City
Villach
ZIP/Postal Code
9500
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J6
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
New Brunswick
ZIP/Postal Code
E2K 5S9
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H8A 2B4
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Havirov
ZIP/Postal Code
736 00
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Strasbourg Cedex
State/Province
Bas Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
Research Site
City
Dijon Cedex
State/Province
Cote dÝOr
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Besancon cedex
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Research Site
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Research Site
City
Bordeaux Cedex
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Colmar cedex
State/Province
Haut Rhin
ZIP/Postal Code
68024
Country
France
Facility Name
Research Site
City
Toulouse cedex 1
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Limoges cedex
State/Province
Haute Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Rennes cedex 09
State/Province
Ille Et Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Grenoble cedex 09
State/Province
Isere
ZIP/Postal Code
39043
Country
France
Facility Name
Research Site
City
Nantes cedex 1
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Reims
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59020
Country
France
Facility Name
Research Site
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
La Roche sur Yon
State/Province
Vendee
ZIP/Postal Code
85025
Country
France
Facility Name
Research Site
City
Poitiers cedex
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Le Chesnay Cedex
State/Province
Yvelines
ZIP/Postal Code
78157
Country
France
Facility Name
Research Site
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Research Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Research Site
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Research Site
City
Castelfiorentino
ZIP/Postal Code
50051
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16153
Country
Italy
Facility Name
Research Site
City
Messina
ZIP/Postal Code
98121
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Research Site
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10124
Country
Italy
Facility Name
Research Site
City
Almada
ZIP/Postal Code
2801-915
Country
Portugal
Facility Name
Research Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Research Site
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Research Site
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Research Site
City
Presov
ZIP/Postal Code
8081
Country
Slovakia
Facility Name
Research Site
City
Ljubljana
ZIP/Postal Code
SI-1525
Country
Slovenia
Facility Name
Research Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Research Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Research Site
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Research Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36204
Country
Spain
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31832225
Citation
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. Erratum In: Mult Scler J Exp Transl Clin. 2020 Apr 29;6(2):2055217320921146.
Results Reference
derived

Learn more about this trial

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

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