check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

18462

ClinicalTrials.gov Identifier:

NCT03134573

EudraCT Number:

Not Available

EU CT Number:

Not Available
Medication usage and Patient Reported Outcomes evaluation via myBETAapp in patients with multiple sclerosis treated with Betaferon: a pilot study

Trial purpose

The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -Patients aged ≥ 18 years.
    -Patients on treatment with Betaferon (every Betaferon box contains a “Mixject” number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study).
    -Patients must be using the myBETAapp.
    -Electronic informed consent must be obtained.
  • -There are no exclusion criteria for participation in this study.

Trial summary

Enrollment Goal
96
Trial Dates
September 2017 - May 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • Compliance to therapy (%)
    Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100
    date_rangeTime Frame:
    6 months
  • Persistence of therapy (yes, no)
    Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)
    date_rangeTime Frame:
    6 months
  • Adherence to therapy (yes, no)
    Patients will be defined as being adherent to therapy if they fulfill the following criteria: a) They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and b)They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)
    date_rangeTime Frame:
    6 months

Secondary Outcome

  • Proportion of patients consenting to participate in this study among those using the myBETAapp
    All patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.
    date_rangeTime Frame:
    3 months
  • Proportion of patients volunteering to record wellness related data in each of the following categories on the “Wellness chart” on the myBETAapp
    Wellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habits
    date_rangeTime Frame:
    3 months

Trial design

PROmyBETAapp: Ascertaining medication usage & documentation of Patient Reported Outcomes utilizing the myBETAapp® in patients with multiple sclerosis treated with Betaferon®: a pilot study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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