CompletedNot Applicable

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

Poland629 participantsStarted 2012-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: 6 months

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

Timeframe: Up to 1 month

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

Timeframe: 6 months

Trial details

NCT IDNCT01706055

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-09

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