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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930708
• Other study ID #: 109MS408
• Secondary ID: 2013-001656-35
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2013
• Est. completion date: January 9, 2020

Study information

• Verified date: March 2020
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1114
• Est. completion date: January 9, 2020
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
Administered as per the approved dosage in all countries where DMF has received marketing authorization.

Locations

Country	Name	City	State
Austria	Research Site	Innsbruck
Austria	Research Site	Klagenfurt
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	St. Polten
Austria	Research Site	Villach
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Brugge
Belgium	Research Site	Bruxelles
Belgium	Research Site	Melsbroek
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	St. John's	New Brunswick
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Victoria	British Columbia
Czechia	Research Site	Brno
Czechia	Research Site	Havirov
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Olomouc
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
France	Research Site	Besancon cedex	Doubs
France	Research Site	Bordeaux Cedex	Gironde
France	Research Site	Colmar cedex	Haut Rhin
France	Research Site	Dijon Cedex	Cote dÝOr
France	Research Site	Grenoble cedex 09	Isere
France	Research Site	La Roche sur Yon	Vendee
France	Research Site	Le Chesnay Cedex	Yvelines
France	Research Site	Lille Cedex	Nord
France	Research Site	Lille Cedex	Nord
France	Research Site	Limoges cedex	Haute Vienne
France	Research Site	Nancy
France	Research Site	Nantes cedex 1	Loire Atlantique
France	Research Site	Nimes	Gard
France	Research Site	Poitiers cedex	Vienne
France	Research Site	Reims	Marne
France	Research Site	Rennes cedex 09	Ille Et Vilaine
France	Research Site	Rouen Cedex
France	Research Site	Strasbourg Cedex	Bas Rhin
France	Research Site	Toulouse cedex 1	Haute Garonne
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Pecs
Hungary	Research Site	Szeged
Hungary	Research Site	Veszprem
Italy	Research Site	Ancona
Italy	Research Site	Bergamo
Italy	Research Site	Bolzano
Italy	Research Site	Castelfiorentino
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Perugia
Italy	Research Site	Pozzilli
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Siena
Italy	Research Site	Torino
Portugal	Research Site	Almada
Portugal	Research Site	Amadora
Portugal	Research Site	Guimarães
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Loures
Portugal	Research Site	Porto
Portugal	Research Site	Porto
Portugal	Research Site	Setúbal
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Presov
Slovenia	Research Site	Ljubljana
Slovenia	Research Site	Maribor
Spain	Research Site	Barcelona
Spain	Research Site	Bilbao
Spain	Research Site	Córdoba
Spain	Research Site	El Palmar
Spain	Research Site	Girona
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Vigo
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  France,  Hungary,  Italy,  Portugal,  Slovakia,  Slovenia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Relapse Rate (ARR)		12 Months
Secondary	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).	12 Months
Secondary	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).	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months
Secondary	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.	12 Months
Secondary	Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6		Baseline, 6 Months
Secondary	The proportion of participants relapsed		12 Months
Secondary	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		12 Months
Secondary	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		12 Months
Secondary	Proportion of participants who report taking the prescribed DMF dose		12 Months
Secondary	Percentage of participants who report taking the prescribed DMF dose		12 Months
Secondary	Reasons reported by participants for not taking prescribed DMF dose		12 Months
Secondary	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).	12 Months