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

September 7, 2012
April 7, 2014
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01706055 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
 
Recruiting
650
December 2015
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)
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Poland
 
NCT01706055
16400, BF1213PL
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

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