NCT04676204

Relationship Between Oral DMT Burden and Adherence in MS

STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 323 (estimated)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Adherence, Medication

Interventions

Type	Name	Description
DRUG	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.
DRUG	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
DRUG	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.
DRUG	Teriflunomide	Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
DRUG	Ozanimod	Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
DRUG	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.

Timeline

• Start date: 2020-09-25
• Primary completion: 2025-11-19
• Completion: 2026-07-11
• First posted: 2020-12-19
• Last updated: 2022-08-31

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study