Clinical trial NCT04676204: Relationship Between Oral DMT Burden and Adherence in MS
Official title: STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Adherence, Medication
Keywords: Multiple Sclerosis
Adherence
Treatment Burden
Disease Modifying Therapy
Oral
Cladribine
Dimethyl fumarate
Fingolimod
Teriflunomide
Ozanimod
Diroximel Fumarate
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Medication Burden
timeFrame: 24-months
measure: Medication Adherence (MPR)
timeFrame: 24-months
measure: Medication Adherence (PDC)
timeFrame: 24-months
Secondary outcomes:
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: 24-Months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash University
state: Victoria
Study officials:
affiliation: Monash University; Monash Health
name: Ernest Butler, PhD; MD
role: PRINCIPAL_INVESTIGATOR
References: