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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02047097
Registration number
NCT02047097
Ethics application status
Date submitted
24/01/2014
Date registered
28/01/2014
Date last updated
24/05/2023
Titles & IDs
Public title
Dimethyl Fumarate (DMF) Observational Study
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Scientific title
A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)
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Secondary ID [1]
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109MS401
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Universal Trial Number (UTN)
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Trial acronym
ESTEEM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - dimethyl fumarate
dimethyl fumarate (DMF) - Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care
Treatment: Drugs: dimethyl fumarate
Provided under routine clinical care
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
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Assessment method [1]
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Timepoint [1]
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Up to 5 years
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Primary outcome [2]
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The number of participants that experience Serious Adverse Events (SAEs)
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Assessment method [2]
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0
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Duration of dimethyl fumarate (DMF) use
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Assessment method [1]
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0
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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0
dimethyl fumarate (DMF) dosing frequency
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Assessment method [2]
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0
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Primary reasons for discontinuation of dimethyl fumarate (DMF) use
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Assessment method [3]
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0
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Frequency of relapses over time
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Assessment method [4]
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0
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Disease progression as measured by Expanded Disability Status Scale (EDSS) over time
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Assessment method [5]
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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. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of = 1 point from baseline system score of = 1 or an increase of = 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of = 2 points from baseline system score of = 1 or an increase of = 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score
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Assessment method [6]
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The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score
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Assessment method [7]
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The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score
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Assessment method [8]
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Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale)
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Assessment method [9]
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Standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state (often referred to as page 3 of the EQ-5D questionnaire)
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Modified Fatigue Impact Scale-5 (MFIS-5) total score
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Assessment method [10]
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MFIS-5 is a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages
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Assessment method [11]
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The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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Health Care Resource Consumption Questionnaire
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Assessment method [12]
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The Health Care Resource Consumption questionnaire is a survey that asks patients how MS affects their use of healthcare services and the impact it has on particular areas of their life (including number of hospitalizations \[MS-related, non-MS related, relapse-related, resulting in steroid use\], MS-related emergency room visits, MS-related neurologist visits, visits to other health care professionals for MS-related and other reasons).
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Timepoint [12]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
- Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.
* Patients participating in other clinical studies.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/10/2022
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Sample size
Target
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Accrual to date
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Final
5487
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - Concord
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Research Site - Auchenflower
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Research Site - Bedford Park
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Research Site - Melbourne
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Research Site - Parkville
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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2217 - Kogarah
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2170 - Liverpool
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2305 - New Lambton Heights
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Recruitment postcode(s) [6]
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2031 - Randwick
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2065 - St. Leonards
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2109 - Sydney
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2145 - Westmead
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Recruitment postcode(s) [10]
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4066 - Auchenflower
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Recruitment postcode(s) [11]
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9726 - Gold Coast
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Recruitment postcode(s) [12]
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5042 - Bedford Park
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Recruitment postcode(s) [13]
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5067 - Kent Town
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Recruitment postcode(s) [14]
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3128 - Box Hill
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Recruitment postcode(s) [15]
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3168 - Clayton
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Recruitment postcode(s) [16]
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3220 - Geelong
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Recruitment postcode(s) [17]
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3084 - Heidelberg
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Recruitment postcode(s) [18]
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3004 - Melbourne
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Recruitment postcode(s) [19]
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3181 - Melbourne
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Recruitment postcode(s) [20]
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3050 - Parkville
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Recruitment postcode(s) [21]
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6009 - Nedlands
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Recruitment outside Australia
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Alabama
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Funding & Sponsors
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Biogen
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Summary
Brief summary
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.
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Trial website
https://clinicaltrials.gov/study/NCT02047097
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Biogen
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https://clinicaltrials.gov/study/NCT02047097
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