Relationship Between Oral DMT Burden and Adherence in MS

Sponsor
Monash University
Study ID
NCT04676204
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 25, 2020
Status verified
Aug 2022
Primary completion
Nov 19, 2025
Completion
Jul 11, 2026

Study Design

Enrollment
323 participants (estimated)

Arms

  • Arm: Cladribine
    Participants with MS commencing cladribine disease modifying treatment as clinically prescribed.
  • Arm: Dimethyl Fumarate
    Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed.
  • Arm: Fingolimod
    Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed.
  • Arm: Teriflunomide
    Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed.
  • Arm: Ozanimod
    Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed.
  • Arm: Diroximel Fumarate
    Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed.

Primary Outcome Measure

Medication Burden [ Time Frame: 24-months ]

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