Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE) (INFLUENCE)
|ClinicalTrials.gov Identifier: NCT01706055|
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Biological: Interferon beta-1b (Betaseron, BAY86-5046)|
|Study Type :||Observational|
|Actual Enrollment :||629 participants|
|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|
Biological: Interferon beta-1b (Betaseron, BAY86-5046)
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01706055
|Many Locations, Poland|
|Study Director:||Bayer Study Director||Bayer|