Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)

Study Overview
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Brief Summary
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This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.

Official Title
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Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®

Conditions
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Multiple Sclerosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria Age >/= 18 years old Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon Minimum 6 months wash-out period from previous IFNβ Written Informed Consent signed Exclusion Criteria: Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier Patients receiving treatment with IFN beta other than Betaferon (Bayer)

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Group 1<br> | Biological: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation |  | 6 months | 
| MS patient with Flu-Like Symptoms (FLS) demographic profile | For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height. | Up to 1 month | 
| Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of FLS on patients daily activities as measured by current professional/educational status |  | From baseline up to 6 months | 
| Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis (MS), Interferon