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| ID | Type | Description | Link |
|---|---|---|---|
| BF1502 | Registry Identifier | NIS Trial Alias |
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This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betaferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon, BAY86-5046) | Drug | Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to therapy (%) | Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))*100 | 12 months |
| Persistence of therapy (Yes or No) | Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake) | 12 months |
| Overall adherence to therapy (Yes or No) | Patients will be defined as being adherent to therapy if they fulfill the following criteria: a. They have been at least 80% compliant, i.e. injected ≥80% of the expected Betaferon dosages and b. They have not dropped out of the study prior to the time of evaluation (i.e. they did not stop Betaferon treatment for any reason including switching to another medication prior to the time of evaluation). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire | Up to 24 months | |
| Adherence to Betaferon treatment is associated with: depression, health related quality of life, coping mechanisms, self-management mechanisms, social support, fatigue, and cognition. (Yes or No) |
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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 |
|---|---|---|---|---|---|---|
| Wermsdorf | Saxony | 04779 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33716945 | Derived | Kohler W, Bayer-Gersmann K, Neusser T, Schurks M, Ziemssen T. Predictors of Adherence Among Patients With Multiple Sclerosis Using the BETACONNECT(R) Autoinjector: A Prospective Observational Cohort Study. Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021. |
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| Betaconnect Autoinjector | Device | Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector. |
|
| Up to 24 months |
| Adherence to Betaferon treatment is associated with number of relapses (Yes or No) | 12 months, 24 months |
| Adherence to Betaferon treatment is associated with EDSS change (Yes or No) | EDSS (Expanded Disability Status Scale) | 12 months, 24 months |
| Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No) | Up to 24 months |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D002278 | Carcinoma in Situ |
| 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 |
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| 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 |
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