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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02776072
Registration number
NCT02776072
Ethics application status
Date submitted
16/05/2016
Date registered
18/05/2016
Date last updated
23/03/2017
Titles & IDs
Public title
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
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Scientific title
A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)
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Secondary ID [1]
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109MS421
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Universal Trial Number (UTN)
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Trial acronym
EFFECT
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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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Condition category
Condition code
Intervention/exposure
Study type
Observational
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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
dimethyl fumarate (DMF) - Participants who initiated DMF during the specified time period
glatiramer acetate (GA) - Participants who initiated GA during the specified time period
teriflunomide - Participants who initiated teriflunomide during the specified time period
fingolimod - Participants who initiated fingolimod during the specified time period
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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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Proportion of participants relapsed at 12 months in participants treated with DMF
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Assessment method [1]
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Single time point per participant retrospective medical record abstraction with no required study visits or procedures
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Timepoint [1]
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One day
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Secondary outcome [1]
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Proportion of participants relapsed at 12 months treated with index therapy in the overall population as well as the subgroup of MS participants who were naïve to DMTs and were diagnosed with MS within 3 years of starting the index therapy
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Assessment method [1]
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Single time point per participant retrospective medical record abstraction with no required study visits or procedures
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Timepoint [1]
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One day
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Secondary outcome [2]
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ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts
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Assessment method [2]
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Single time point per participant retrospective medical record abstraction with no required study visits or procedures
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Timepoint [2]
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One day
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Secondary outcome [3]
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Proportion of relapsed participants with one or more MS-related hospitalizations during the 12 months following treatment initiation in participants treated with index therapy in the overall population and the matched cohorts
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Assessment method [3]
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Single time point per participant retrospective medical record abstraction with no required study visits or procedures
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Timepoint [3]
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One day
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Secondary outcome [4]
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Proportion of relapsed participants requiring treatment with intravenous corticosteroids during the 12 months following treatment initiation in participants treated with index therapy in the overall participant population and the matched cohorts
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Assessment method [4]
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Single time point per participant retrospective medical record abstraction with no required study visits or procedures
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Timepoint [4]
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One day
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Eligibility
Key inclusion criteria
Key
- Diagnosis of RRMS per McDonald criteria
- Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index
therapy) no earlier than January 2011 and no later than 12 months prior to the date of
medical record abstraction (i.e., patient has at least 12 months of data available in
the medical record following initiation of index treatment). Note: Patients who have
initiated the index therapy but subsequently discontinued or switched to other
therapies are allowed in this study as long as there is at least 12 months of
follow-up following the initiation of the index therapy.
- Have sufficient available medical records for data abstraction to meet the objectives
of the study, i.e., the patient was either under the medical care of the investigating
site during the entire period of the index treatment or the patient's complete MS
disease and treatment history is otherwise available at the investigating site
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Minimum age
18
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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
- Diagnosis of a progressive form of MS (progressive relapsing, primary progressive,
secondary progressive) at any time before or during the period for which data will be
collected
- Have received disease-modifying therapies other than one platform therapy (IFN or GA)
prior to initiation of index therapy. In patients for whom GA is index therapy, only
one prior IFN therapy is allowed.
- Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g.,
Psorinovo) at any time prior to initiation of treatment with Tecfidera®
- Concurrent enrollment in any interventional clinical trial of an investigational
product during time evaluated for medical record abstraction
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
Retrospective
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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
1/05/2016
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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
1/12/2016
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Sample size
Target
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Accrual to date
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Final
2978
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - New Lambton Heights
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Research Site - Box Hill
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Research Site - Heidelberg
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Research Site - Melbourne
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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3128 - Box Hill
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Summary
Brief summary
The primary objective of the study is to evaluate the real-world clinical effectiveness, as
measured by the proportion of participants relapsed at 12 months, in participants treated
with dimethyl fumarate (DMF).
Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as
measured by the proportion of participants relapsed at 12 months, in participants treated
with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall
participant cohort and in a subset of participants who were naïve to disease-modifying
therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the
index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among
participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related
hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To
compare intravenous corticosteroid use among participants treated with DMF, GA,
teriflunomide, or fingolimod.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02776072
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Biogen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02776072
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