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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

NCT ID: NCT04356339

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-24

Study Completion Date

2021-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BETASERON

Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled

Interferon-beta-1b (BETASERON, BAY 86-5046)

Intervention Type DRUG

Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician

Interventions

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Interferon-beta-1b (BETASERON, BAY 86-5046)

Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18 years
* Treated with BETASERON using the BETACONNECT autoinjector
* Registered with myBETAapp
* Provided electronic informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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myBETAapp

Whippany, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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20756

Identifier Type: -

Identifier Source: org_study_id

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