Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04676204




Registration number
NCT04676204
Ethics application status
Date submitted
25/11/2020
Date registered
19/12/2020
Date last updated
31/08/2022

Titles & IDs
Public title
Relationship Between Oral DMT Burden and Adherence in MS
Scientific title
STATURE: A Prospective Observational Study of the relationShip beTween Oral DMT bURden and adhErence in People With MS
Secondary ID [1] 0 0
STATURE01
Universal Trial Number (UTN)
Trial acronym
STATURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Adherence, Medication 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Cladribine
Treatment: Drugs - Dimethyl fumarate
Treatment: Drugs - Fingolimod
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Ozanimod
Treatment: Drugs - Diroximel fumarate

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

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

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

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

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

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


Treatment: Drugs: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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.

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

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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Medication Burden
Timepoint [1] 0 0
24-months
Primary outcome [2] 0 0
Medication Adherence (MPR)
Timepoint [2] 0 0
24-months
Primary outcome [3] 0 0
Medication Adherence (PDC)
Timepoint [3] 0 0
24-months
Secondary outcome [1] 0 0
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Timepoint [1] 0 0
24-Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/07/2026
Actual
Sample size
Target
323
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04676204
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ernest Butler, PhD; MD
Address 0 0
Monash University; Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04676204