check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

16400

ClinicalTrials.gov Identifier:

NCT01706055

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of strategies for the management of flu-like symptoms in MS patients commencing treatment with Betaferon (INFLUENCE)

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
September 2012 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 1 month
    enhanced_encryption
    Safety Issue:
    No
  • Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
    date_rangeTime Frame:
    6 months

Secondary Outcome

  • The impact of FLS on patients daily activities as measured by current professional/educational status
    date_rangeTime Frame:
    From baseline up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.