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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
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)
Secondary ID [1] 0 0
109MS401
Universal Trial Number (UTN)
Trial acronym
ESTEEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
The number of participants that experience Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Duration of dimethyl fumarate (DMF) use
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
dimethyl fumarate (DMF) dosing frequency
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Primary reasons for discontinuation of dimethyl fumarate (DMF) use
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Frequency of relapses over time
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Disease progression as measured by Expanded Disability Status Scale (EDSS) over time
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Modified Fatigue Impact Scale-5 (MFIS-5) total score
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Health Care Resource Consumption Questionnaire
Timepoint [12] 0 0
Up to 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2022
Sample size
Target
Accrual to date
Final
5487
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Liverpool
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Research Site - New Lambton Heights
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Research Site - Randwick
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Research Site - St. Leonards
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Research Site - Sydney
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Research Site - Westmead
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Research Site - Auchenflower
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Research Site - Gold Coast
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Research Site - Bedford Park
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Research Site - Kent Town
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Research Site - Box Hill
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Research Site - Clayton
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Research Site - Geelong
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Research Site - Heidelberg
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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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2050 - Camperdown
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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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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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4066 - Auchenflower
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9726 - Gold Coast
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5042 - Bedford Park
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5067 - Kent Town
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3128 - Box Hill
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3168 - Clayton
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3220 - Geelong
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3084 - Heidelberg
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3004 - Melbourne
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3181 - Melbourne
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3050 - Parkville
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
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West Yorkshire
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United Kingdom
State/province [212] 0 0
Belfast
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
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Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02047097
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
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Biogen
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02047097