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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT01706055
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-15
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
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	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	6 months

Secondary Outcome Measures

Name	Time	Method
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