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

Bayer629 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

629

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)BIOLOGICAL

Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Many Locations, Poland

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

For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.

Time frame: Up to 1 month

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

Time frame: From baseline up to 6 months

Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period

Time frame: 6 months

Data from ClinicalTrials.gov

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