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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706055
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):

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.

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

Study Type : Observational
Actual Enrollment : 629 participants
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®
Study Start Date : September 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation [ Time Frame: 6 months ]
  2. MS patient with Flu-Like Symptoms (FLS) demographic profile [ Time Frame: Up to 1 month ]
    For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.

  3. Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The impact of FLS on patients daily activities as measured by current professional/educational status [ Time Frame: From baseline up to 6 months ]
  2. Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult MS patients starting Betaferon therapy

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01706055

Many Locations, Poland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01706055     History of Changes
Other Study ID Numbers: 16400
BF1213PL ( Other Identifier: company internal )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Bayer:
Multiple Sclerosis (MS)

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