Multiple SclerosisSTATURENCT04676204
Relationship Between Oral DMT Burden and Adherence in MS
An observational study of Multiple Sclerosis and Adherence, Medication, run by Monash University at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis, Adherence, Medication
- What is being tested?
- Cladribine, Dimethyl fumarate and Fingolimod
- How many people
- 323 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2020to 11 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three-hundred and twenty-three people with MS, who have recently commenced (<2-months) one of the six oral DMTs under investigation during routine clinical care
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS
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.
- Conditions
- Multiple Sclerosis, Adherence, Medication
- Being tested
- Cladribine, Dimethyl fumarate, Fingolimod, Teriflunomide, Ozanimod
- Keywords
- Multiple Sclerosis, Adherence, Treatment Burden, Disease Modifying Therapy, Oral, Cladribine, Dimethyl fumarate, Fingolimod, Teriflunomide, Ozanimod, Diroximel Fumarate
- Medical subject headings
- Multiple Sclerosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
Also called Mavenclad
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 fumarateDrug
Also called Tecfidera
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
FingolimodDrug
Also called Gilenya
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.
TeriflunomideDrug
Also called Aubagio
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
OzanimodDrug
Also called Zeposia
Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Diroximel fumarateDrug
Also called Vumerity
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.
| Study group | Role | What they receive |
|---|---|---|
| Cladribine | Participants with MS commencing cladribine disease modifying treatment as clinically prescribed. Receives: Drug: Cladribine | |
| Dimethyl Fumarate | Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed. Receives: Drug: Dimethyl fumarate | |
| Fingolimod | Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed. Receives: Drug: Fingolimod | |
| Teriflunomide | Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed. Receives: Drug: Teriflunomide | |
| Ozanimod | Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed. Receives: Drug: Ozanimod | |
| Diroximel Fumarate | Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed. Receives: Drug: Diroximel fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24-months
Secondary outcomes (1)
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.
Measured: 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start25 Sep 2020
- Primary completion19 Nov 2025 (estimated)
- Study completion11 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest Butler, Monash University
- Investigators
- Ernest Butler, PhD; MD, Principal investigator, Monash University; Monash Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676204
- Sponsor's protocol ID
- STATURE01
- Acronym
- STATURE
- Status last verified
- Aug 2022
- First submitted
- 25 Nov 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS
- ClinicalTrials.gov ID
- NCT04676204
- Acronym / sponsor ID
- STATURE / STATURE01
- Conditions
- Multiple Sclerosis, Adherence, Medication
- Keywords
- Multiple Sclerosis, Adherence, Treatment Burden, Disease Modifying Therapy, Oral, Cladribine, Dimethyl fumarate, Fingolimod
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 19 Nov 2025 (estimated)
- Study completion
- 11 Jul 2026 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cladribine | – | Drug: CladribineParticipants with MS commencing cladribine disease modifying treatment as clinically prescribed. |
| Dimethyl Fumarate | – | Drug: Dimethyl fumarateParticipants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed. |
| Fingolimod | – | Drug: FingolimodParticipants with MS commencing fingolimod disease modifying treatment as clinically prescribed. |
| Teriflunomide | – | Drug: TeriflunomideParticipants with MS commencing teriflunomide disease modifying treatment as clinically prescribed. |
| Ozanimod | – | Drug: OzanimodParticipants with MS commencing Ozanimod disease modifying treatment as clinically prescribed. |
| Diroximel Fumarate | – | Drug: Diroximel fumarateParticipants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three-hundred and twenty-three people with MS, who have recently commenced (<2-months) one of the six oral DMTs under investigation during routine clinical care
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CladribineAlso: MavencladCladribine 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. | Drug | Cladribine |
| Dimethyl fumarateAlso: TecfideraDimethyl 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 | Drug | Dimethyl Fumarate |
| FingolimodAlso: GilenyaFingolimod 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. | Drug | Fingolimod |
| TeriflunomideAlso: AubagioTeriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis. | Drug | Teriflunomide |
| OzanimodAlso: ZeposiaOzanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis. | Drug | Ozanimod |
| Diroximel fumarateAlso: VumerityDiroximel 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. | Drug | Diroximel Fumarate |
Primary outcome
Medication Burden
Time frame: 24-months
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.
Medication Adherence (MPR)
Time frame: 24-months
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.
Medication Adherence (PDC)
Time frame: 24-months
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.
1 secondary outcome
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: 24-Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Butler, PhD; MD principal investigator
Monash University; Monash Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Adherence, Medication, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Burden (time frame: 24-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.