check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

20756

ClinicalTrials.gov Identifier:

NCT04356339

EudraCT Number:

Not Available

EU CT Number:

Not Available
US PROmyBETAapp2.0: A study to learn more about the medication usage and patient reported outcomes via the myBETAapp in medical care of patients with multiple sclerosis treated with BETASERON using BETACONNECT autoinjector

Trial purpose

In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent
- taking medication matches the presciber′s recommendation (adherence, compliance),
- treatment for the prescribed duration (persistence) is continued and
- injections were missed.
Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Aged ≥18 years
    - Treated with BETASERON using the BETACONNECT autoinjector
    - Registered with myBETAapp
    - Provided electronic informed consent
  • - There are no exclusion criteria for participation in this study

Trial summary

Enrollment Goal
100
Trial Dates
November 2020 - November 2021
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
myBETAappWhippany, 07981, United States

Primary Outcome

  • Compliance to therapy
    Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.
    date_rangeTime Frame:
    Up to 6 months
  • Persistence of therapy
    Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.
    date_rangeTime Frame:
    Up to 6 months
  • Adherence to therapy
    Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.
    date_rangeTime Frame:
    Up to 6 months

Secondary Outcome

  • Change in patient-reported health-related quality of life (HRQOL)
    Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.
    date_rangeTime Frame:
    Up to 6 months
  • Patient satisfaction with the myBETAapp
    Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.
    date_rangeTime Frame:
    Up to 6 months
  • Change in health status evaluated by EQ-5D-5L descriptive system
    EQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems).
    date_rangeTime Frame:
    Up to 6 months
  • Change in EQ-Visual Analog Score (EQ-VAS)
    The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’ and provides a single quantitative measure of health.
    date_rangeTime Frame:
    Up to 6 months
  • Change in prescription and non-prescription medication usage
    Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.
    date_rangeTime Frame:
    Up to 6 months
  • Number of relapses
    date_rangeTime Frame:
    Up to 6 months
  • Number of participants with treatment with corticosteroids due to relapses
    date_rangeTime Frame:
    Up to 6 months
  • Number of emergency room visits due to relapse
    date_rangeTime Frame:
    Up to 6 months
  • Number of hospitalizations due to relapse
    date_rangeTime Frame:
    Up to 6 months
  • Patient self-assessment
    Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.
    date_rangeTime Frame:
    Up to 6 months
  • Change in dose of BETASERON prescription
    date_rangeTime Frame:
    Up to 6 months
  • Change in frequency of BETASERON prescription
    date_rangeTime Frame:
    Up to 6 months
  • Patient satisfaction with the BETACONNECT autoinjector
    Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.
    date_rangeTime Frame:
    Up to 6 months

Trial design

US PROmyBETAapp2.0: Ascertaining medication usage and patient-reported outcomes (PROs) via the myBETAapp™ in patients with Multiple Sclerosis treated with BETASERON® using BETACONNECT™ autoinjector
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A