Multiple Sclerosis
Conditions
Keywords
Interferon beta-1b (INFb-1b), Multiple Sclerosis (MS), Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Clinically isolated syndrome (CIS)
Brief summary
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.
Interventions
Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b
Exclusion criteria
\-
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with MS diagnosis | At baseline | — |
| 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 | — |
| Demographic data | At baseline | Age, sex, marital status, education level, employment status |
| Number of patients with adverse events during the last month | Four weeks just before baseline visit | — |
| Clinical setting characteristics like existence of MS unit | At baseline | 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. |
| Time on INFb-1b therapy | At baseline | — |
| Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS | At baseline | 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. |
Outcome results
None listed