Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BF0704 | Other Identifier | Company Internal |
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
Not provided
Not provided
Not provided
Not provided
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 - Ways of Coping Questionnaire) and depression questionnaire CES-D.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients, who were recruited at neurologic practices or specialized neurological centers, were eligible for selection if they had relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21636099 | Result | Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN beta-1b in multiple sclerosis--results of the betaPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Many Locations |
| France |
| Many Locations | Germany |
| Many Locations | Iran |
| Many Locations | Israel |
| Many Locations | Italy |
| Many Locations | Jordan |
| Many Locations | Lebanon |
| Many Locations | Netherlands |
| Many Locations | Portugal |
| Many Locations | Saudi Arabia |
| Many Locations | South Korea |
| Many Locations | Spain |
| Many Locations | Taiwan |
| Many Locations | Turkey (Türkiye) |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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