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

NCT01706055 | Completed

• 2 other identifiers: 16400BF1213PL
• Study Type: observational
• Target: 629
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis (MS); Interferon

Outcome Measures

Primary Outcomes (3)

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

  6 months

• 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

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

  6 months

Secondary Outcomes (2)

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

  From baseline up to 6 months

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

  6 months

Study Arms (1)

Group 1

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

Interventions

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

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult MS patients starting Betaferon therapy

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: October 15, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

PL (1)