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| ID | Type | Description | Link |
|---|---|---|---|
| BF0710PT | Other Identifier | Company internal |
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This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ) and depression questionnaire CES-D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046) | Drug | 250 µg, sub-cutaneously, on alternate days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others. | After 2 years | |
| Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others. | After 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence. | After 2 years | |
| Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with RRMS or SPMS attending an hospital outpatient MS clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Portugal |
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| After 2 years |
| Assessment of coping processes by applying the Ways of Coping Questionnaire. | After 2 years |
| Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category. | After 2 years |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009103 | Multiple Sclerosis |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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