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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cladribine | Participants with MS commencing cladribine disease modifying treatment as clinically prescribed. |
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| Dimethyl Fumarate | Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed. |
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| Fingolimod | Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed. |
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| Teriflunomide | Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed. |
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| Ozanimod | Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed. |
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| Diroximel Fumarate | Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cladribine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ernest Butler, PhD; MD | Monash University; Monash Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash University | Melbourne | Victoria | 3800 | Australia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2020 | Nov 25, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D017338 | Cladribine |
| D000069462 | Dimethyl Fumarate |
| D000068876 | Fingolimod Hydrochloride |
| C527525 | teriflunomide |
| C000607776 | ozanimod |
| C000722501 | diroximel fumarate |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
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| Dimethyl fumarate | Drug | 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 |
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| Fingolimod | Drug | 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. |
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| Teriflunomide | Drug | Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis. |
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| Ozanimod | Drug | Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis. |
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| Diroximel fumarate | Drug | 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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| 24-Months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |