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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: March 13, 2017
Last verified: March 2017
September 7, 2012
March 13, 2017
September 2012
September 2015   (Final data collection date for primary outcome measure)
  • Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation [ Time Frame: 6 months ]
  • 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.
  • Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS [ Time Frame: 6 months ]
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01706055 on ClinicalTrials.gov Archive Site
  • The impact of FLS on patients daily activities as measured by current professional/educational status [ Time Frame: From baseline up to 6 months ]
  • Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period [ Time Frame: 6 months ]
  • Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS [ Time Frame: 6 months ]
  • 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 ]
  • Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period [ Time Frame: 6 months ]
  • 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.
Not Provided
Not Provided
 
Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)
Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult MS patients starting Betaferon therapy
Multiple Sclerosis
Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.
Group 1
Intervention: Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
629
March 2016
September 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01706055
16400
BF1213PL ( Other Identifier: company internal )
No
Not Provided
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP