Trial Condition(s):
Multiple Sclerosis
Assessment of strategies for the management of flu-like symptoms in MS patients commencing treatment with Betaferon (INFLUENCE) (INFLUENCE)
Bayer Identifier:
16400
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Assessment of strategies for the management of flu-like symptoms in MS patients commencing treatment with Betaferon®
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiationTimeframe: 6 months
- MS patient with Flu-Like Symptoms (FLS) demographic profileFor demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.Timeframe: Up to 1 month
- Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLSTimeframe: 6 months
Secondary Outcome
- The impact of FLS on patients daily activities as measured by current professional/educational statusTimeframe: From baseline up to 6 months
- Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months periodTimeframe: 6 months
Additional Information
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