Clinical trial · Observational
Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study
PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study
NCT03134573CI-TRIAL-00037798PROmyBETAappcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Sclerosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Betaconnect auto-injector | Device | — | UNRESOLVED |
| Interferon beta-1b (Betaferon, BAY86-5046) | Drug | Interferon Beta-1b | ALIAS |
| myBETAapp | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Multiple Sclerosis
- description
- Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp
- interventionNames
- Drug: Interferon beta-1b (Betaferon, BAY86-5046)
- Device: Betaconnect auto-injector
- Device: myBETAapp
Primary outcomes (3)
- measure
- Compliance to therapy (%)
- timeFrame
- 6 months
- description
- 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
- measure
- Persistence of therapy (yes, no)
- timeFrame
- 6 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: -There are no exclusion criteria for participation in this study.
References
Publications (1)
- DERIVEDLimmroth V, Hechenbichler K, Muller C, Schurks M. Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp). J Med Internet Res. 2019 Jul 29;21(7):e14373. doi: 10.2196/14373. PMID 31359863