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| ID | Type | Description | Link |
|---|---|---|---|
| BF1414DE | Other Identifier | Company internal |
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This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon, BAY 86-5046) | Drug |
| ||
| BETACONNECT auto-injector. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence measure to Betaferon therapy based on the real BETACONNECT injections | Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire | up to 24 weeks | |
| Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28877664 | Derived | Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuss B, Schurks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT(R) autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Device |
|
| up to 24 weeks |
| Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) | up to 24 weeks |
| Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) | up to 24 weeks |
| Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) | up to 24 weeks |
| Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) | up to 24 weeks |
| Local skin reactions recorded by Health Care Provider (HCP) evaluation | up to 24 weeks |
| Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device | up to 24 weeks |
| Number of Treatment-emergent Adverse Events (TEAE) | up to 24 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |