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The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon beta-1b | Patients with CIS, RRMS or SPMS who had more than 6 months in treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046) | Drug | Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test | Four weeks just before baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | Age, sex, marital status, education level, employment status | At baseline |
| Number of patients with MS diagnosis | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
-
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This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22615737 | Result | Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16. |
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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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| Age at first episode and at diagnosis | At baseline |
| Time since last relapse | At baseline |
| Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team | At baseline |
| Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS | The EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis. | At baseline |
| Number of patients with adverse events during the last month | Four weeks just before baseline visit |
| Clinical setting characteristics like existence of MS unit | The existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department. | At baseline |
| Time on INFb-1b therapy | At baseline |
| 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 |