Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BF1504 | Other Identifier | IMPACT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Sclerosis | Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon, BAY86-5046) | Drug | Solution for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 6 months |
| Adherence to therapy (yes, no) | Patients will be defined as being adherent to therapy if they fulfill the following criteria:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-There are no exclusion criteria for participation in this study.
Not provided
Not provided
Not provided
The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31359863 | Derived | Limmroth 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Betaconnect auto-injector |
| Device |
Auto-injector for application of Betaferon solution which automatically covers injection related data |
|
| myBETAapp | Device | Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker |
|
| 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 | 3 months |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D002278 | Carcinoma in Situ |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided