Relationship Between Oral DMT Burden and Adherence in MS

NCT04676204 | Enrolling By Invitation FDA Drug

• 1 other identifier: STATURE01
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multiple Sclerosis; Adherence; Treatment Burden; Disease Modifying Therapy; Oral; Cladribine; Dimethyl fumarate; Fingolimod; Teriflunomide; Ozanimod; Diroximel Fumarate

Outcome Measures

Primary Outcomes (3)

• Medication Burden

  Identification of medication burden will be calculated into indices of pre-workup and monitoring time, refill and administration and side-effects. This will allow the development of an indices of overall perceived burden, as well as sub-indices of specific perceived burden.

  24-months

• Medication Adherence (MPR)

  Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the medication possession ratio (MPR) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.

  24-months

• Medication Adherence (PDC)

  Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the proportion of days covered (PDC) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.

  24-months

Secondary Outcomes (1)

• Multiple Sclerosis Quality of Life-54 (MSQOL-54)

  24-Months

Study Arms (6)

Cladribine

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

Drug: Cladribine

Dimethyl Fumarate

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

Drug: Dimethyl fumarate

Fingolimod

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

Drug: Fingolimod

Teriflunomide

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

Drug: Teriflunomide

Ozanimod

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

Drug: Ozanimod

Diroximel Fumarate

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

Drug: Diroximel fumarate

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.

Also known as: Mavenclad

Cladribine

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

Also known as: Tecfidera

Dimethyl Fumarate

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.

Also known as: Gilenya

Fingolimod

Teriflunomide DRUG

Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Also known as: Aubagio

Teriflunomide

Ozanimod DRUG

Ozanimod is a sphingosine-1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Also known as: Zeposia

Ozanimod

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.

Also known as: Vumerity

Diroximel Fumarate

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three-hundred and twenty-three people with MS, who have recently commenced (\<2-months) one of the six oral DMTs under investigation during routine clinical care

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Monash University

Melbourne, Victoria, 3800, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Medication Adherence

Interventions

Cladribine; Dimethyl Fumarate; Fingolimod Hydrochloride; teriflunomide; ozanimod; diroximel fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sphingosine; Amino Alcohols; Alcohols; Propylene Glycols; Glycols; Amines

Study Officials

• Ernest Butler, PhD; MD

  Monash University; Monash Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 19, 2020
• Study Start: September 25, 2020
• Primary Completion: November 19, 2025
• Study Completion (Estimated): July 11, 2026
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)