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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01706055
First received: September 7, 2012
Last updated: April 7, 2014
Last verified: April 2014
  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.


Condition Intervention
Multiple Sclerosis
Biological: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of daily activities impairment of patients with FLS, based on patient's self assessment using four categories [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
  • Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MS patient with Flu-Like Symptoms (FLS) demographic profile. [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.


Estimated Enrollment: 650
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult MS patients starting Betaferon therapy

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706055

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Poland
Recruiting
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01706055     History of Changes
Other Study ID Numbers: 16400, BF1213PL
Study First Received: September 7, 2012
Last Updated: April 7, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Multiple Sclerosis (MS)
Interferon

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 20, 2014