Enrolling by InvitationN/ADMT

Relationship Between Oral DMT Burden and Adherence in MS

Sponsored by Monash University

NCT ID
NCT04676204
Target Enrollment
323 participants
Start Date
2020-09-25
Est. Completion
2026-07-11

About This Study

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 Studied

Multiple SclerosisAdherence, Medication

Interventions

  • Cladribine
  • Dimethyl fumarate
  • Fingolimod
  • Teriflunomide
  • Ozanimod
  • Diroximel fumarate

Eligibility

Age:18 Years - 99 Years
Healthy Volunteers:No
View full 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).

Study Locations (1)

Monash University
Melbourne, Victoria, Australia

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

Relationship Between Oral DMT Burden and Adherence in MS | Huxley