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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01706055
First received: September 7, 2012
Last updated: April 29, 2016
Last verified: April 2016
  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.


Enrollment: 629
Study Start Date: September 2012
Study Completion Date: March 2016
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706055

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

Additional Information:
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 29, 2016
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 21, 2016