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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01706055

Acronym

INFLUENCE

Enrollment

629

Registered

2012-10-15

Start date

2012-09-30

Completion date

2016-03-31

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis (MS), Interferon

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.

Interventions

BIOLOGICALInterferon beta-1b (Betaseron, BAY86-5046)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026