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NCT04356339 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 100
- Enrollment target
NCT04356339: Completed study, sponsored by Bayer.
NCT04356339 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04356339 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Interferon-beta-1b (BETASERON, BAY 86-5046)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2021-11-11 |
What the finished NCT04356339 record still lists
NCT04356339 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Interferon-beta-1b (BETASERON, BAY 86-5046) is the first listed.
NCT04356339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04356339 about?
NCT04356339 is a clinical study titled "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". 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. M...
What is the current status of trial NCT04356339?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2020-11-24. Estimated completion is 2021-11-11.
What interventions are being tested in trial NCT04356339?
The interventions under investigation include: Interferon-beta-1b (BETASERON, BAY 86-5046) (DRUG).
Who is sponsoring clinical trial NCT04356339?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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