Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

Study Overview
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Brief Summary
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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.

Official Title
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Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interferon beta-1b<br>Patients with CIS, RRMS or SPMS who had more than 6 months in treatment | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Age, sex, marital status, education level, employment status | At baseline | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interferon beta-1b (INFb-1b), Multiple Sclerosis (MS), Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Clinically isolated syndrome (CIS)