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By invitation only NCT04676204

Relationship Between Oral DMT Burden and Adherence in MS

Conditions: Multiple Sclerosis Adherence, Medication

Sponsor: Monash University

trial.available_in: БГ
Overview
STATURE is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. The primary aim is to measure treatment burden and its relationship to medication adherence across six self-administered oral disease-modifying therapies (cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, and diroximel fumarate) in multiple sclerosis (MS). The information gained will assist prescribing decision-making; accounting for medication burden at a patient level and potential implications on medication adherence and persistence, thus minimising primary and secondary healthcare costs. Three-hundred and twenty-three individuals with MS will be recruited into the study. Patient-reported outcome measures will be administered via Qualtrics, a secure online data collection tool. Medicare and pharmaceutical benefits scheme (PBS) data will also be collected.
Who can participate
Inclusion Criteria: * 18 years or older. * A confirmed diagnosis of multiple sclerosis. * Commencement (switching or newly prescribed) of one of the 6 following DMTs within the previous 2-months: cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate. * Able to read and write in English. * Access to an internet connection and computer facilities, required to complete assessments. Exclusion Criteria: * Use of any other DMT than cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate. * Comorbid neurological condition. * Severe cognitive or psychological dysfunction deemed to interfere with the person's ability to undertake study requirements, as determined by their MS clinic treatment team (neurologist; MS nurse).
Locations 1
Australia (1)
Monash University
Melbourne , Victoria
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
25.09.2020
Completion date
11.07.2026
Registry ID
NCT04676204
Source
anzctr
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