STATURE
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Cladribine
DNA inhibitor
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Fingolimod
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
- Diroximel fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Medication Burden
24-months
Medication Adherence (MPR)
24-months
Quality of life (reported by participants)Medication Adherence (PDC)
24-months
Quality of life (reported by participants)
Other measures (1)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
24-Months
Bladder, bowel and sexual functionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 99
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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Sept 2020
Main results due
Nov 2025
Finished
Jul 2026
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