Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis (BREAK)
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.
Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.
This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis|
- Rate of discontinuation of Betaferon [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Number of missed doses of Betaferon [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Depression score as measured by CES-D questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Neurological disability score as measured by EDSS scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2011|
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184833
|Many Locations, Poland|
|Study Director:||Bayer Study Director||Bayer|