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.
Study Type
OBSERVATIONAL
Enrollment
323
Cladribine is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis, to include relapsing-remitting disease and active secondary progressive disease, in adults.
Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Diroximel fumarate is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Monash University
Melbourne, Victoria, Australia
Medication Burden
Identification of medication burden will be calculated into indices of pre-workup and monitoring time, refill and administration and side-effects. This will allow the development of an indices of overall perceived burden, as well as sub-indices of specific perceived burden.
Time frame: 24-months
Medication Adherence (MPR)
Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the medication possession ratio (MPR) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.
Time frame: 24-months
Medication Adherence (PDC)
Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the proportion of days covered (PDC) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.
Time frame: 24-months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a structured, self-report questionnaire examining quality of life that contains 54-items, generating 12 subscales with two summary scores (physical health and mental health) and two additional single-item measures (satisfaction with sexual function and change in health). In scoring the MSQOL-54, two summary scores (physical and mental health) are produced from a weighted combination of scale scores, where scale scores range from 0 to 100, with higher scale score indicating improved quality of life. Quality of life (QoL) is being utilised as an outcome measure to identify whether QoL is predicted by 24-month MPR/PDC adherence and persistence.
Time frame: 24-Months
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