Relationship Between Oral DMT Burden and Adherence in MS

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

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.

Sponsors & Collaborators

• Monash University

  lead OTHER

Principal Investigators

• Ernest Butler, PhD; MD · Monash University; Monash Health

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-25

Primary Completion

2025-11-19

Completion

2026-07-11

FDA Drug

Yes

Countries

• Australia

Study Locations