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:

NCT01706055

EudraCT Number:

Not Available

Study Completed

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
629
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 

Trial Design