Relationship Between Oral DMT Burden and Adherence in MS (STATURE)

Monash University

Status: Invitation-only

Conditions: Adherence, Medication; Multiple Sclerosis

Treatments: Drug: Diroximel fumarate; Drug: Fingolimod; Drug: Dimethyl fumarate; Drug: Ozanimod; Drug: Cladribine; Drug: Teriflunomide

Study type: Observational

Funder types: Other

Identifiers

NCT04676204

STATURE01

Details and patient eligibility

About

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.

Enrollment: 323 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

323 participants in 6 patient groups

Cladribine

Description:

Participants with MS commencing cladribine disease modifying treatment as clinically prescribed.

Treatment:

Drug: Cladribine

Dimethyl Fumarate

Description:

Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed.

Treatment:

Drug: Dimethyl fumarate

Fingolimod

Description:

Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed.

Treatment:

Drug: Fingolimod

Teriflunomide

Description:

Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed.

Treatment:

Drug: Teriflunomide

Ozanimod

Description:

Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed.

Treatment:

Drug: Ozanimod

Diroximel Fumarate

Description:

Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed.

Treatment:

Drug: Diroximel fumarate