Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Bayer
- Enrollment
- 629
- Primary Endpoint
- Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
Time Frame: 6 months
MS patient with Flu-Like Symptoms (FLS) demographic profile
Time Frame: Up to 1 month
For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.
Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
Time Frame: 6 months
Secondary Outcomes
- 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)