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

Multiple Sclerosis Clinical Trial

— INFLUENCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706055
• Other study ID #: 16400
• Secondary ID: BF1213PL
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: March 13, 2017
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 IFNß

• Written Informed Consent signed

Exclusion Criteria:

• Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNß therapy which ended at least 6 months earlier

• Patients receiving treatment with IFN beta other than Betaferon (Bayer)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• Interferon beta-1b (Betaseron, BAY86-5046)
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation		6 months
Primary	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.	Up to 1 month
Primary	Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS		6 months
Secondary	The impact of FLS on patients daily activities as measured by current professional/educational status		From baseline up to 6 months
Secondary	Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period		6 months

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