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NCT Number: NCT01706055

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Biological

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

Primary outcomes

  1. Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation

    Time frame: 6 months

  2. MS patient with Flu-Like Symptoms (FLS) demographic profile

    Time frame: Up to 1 month

    For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.

  3. Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS

    Time frame: 6 months

Secondary outcomes

  1. The impact of FLS on patients daily activities as measured by current professional/educational status

    Time frame: From baseline up to 6 months

  2. Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: INFLUENCE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 15, 2012
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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