Status unknownMS (type not specified)NCT04676204

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

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

    1. Started

      Sept 2020

    2. Main results due

      Nov 2025

    3. Finished

      Jul 2026

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