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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04676204
Registration number
NCT04676204
Ethics application status
Date submitted
25/11/2020
Date registered
19/12/2020
Titles & IDs
Public title
Relationship Between Oral DMT Burden and Adherence in MS
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Scientific title
STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS
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Secondary ID [1]
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STATURE01
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Universal Trial Number (UTN)
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Trial acronym
STATURE
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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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Adherence, Medication
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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
Treatment: Drugs - Cladribine
Treatment: Drugs - Dimethyl fumarate
Treatment: Drugs - Fingolimod
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Ozanimod
Treatment: Drugs - Diroximel fumarate
Cladribine - Participants with MS commencing cladribine disease modifying treatment as clinically prescribed.
Dimethyl Fumarate - Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed.
Fingolimod - Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed.
Teriflunomide - Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed.
Ozanimod - Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed.
Diroximel Fumarate - Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed.
Treatment: Drugs: Cladribine
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.
Treatment: Drugs: Dimethyl fumarate
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
Treatment: Drugs: Fingolimod
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.
Treatment: Drugs: Teriflunomide
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Treatment: Drugs: Ozanimod
Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Treatment: Drugs: Diroximel fumarate
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.
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Intervention code [1]
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Treatment: Drugs
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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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Medication Burden
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Assessment method [1]
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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.
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Timepoint [1]
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24-months
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Primary outcome [2]
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Medication Adherence (MPR)
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Assessment method [2]
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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.
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Timepoint [2]
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24-months
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Primary outcome [3]
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Medication Adherence (PDC)
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Assessment method [3]
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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.
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Timepoint [3]
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24-months
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Secondary outcome [1]
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Multiple Sclerosis Quality of Life-54 (MSQOL-54)
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Assessment method [1]
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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.
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Timepoint [1]
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24-Months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
99
Years
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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
* 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).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
25/09/2020
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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
11/07/2026
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Actual
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Sample size
Target
323
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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3800 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT04676204
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ernest Butler, PhD; MD
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Address
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Monash University; Monash Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Informed consent form
https://cdn.clinicaltrials.gov/large-docs/04/NCT04676204/ICF_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04676204