Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
- Registration Number
- NCT01184833
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 852
- Relapsing-remitting multiple sclerosis
- Age >/= 18 years
- Start of treatment with Betaferon not earlier than 60 days prior to inclusion
- Synonymous with contraindications to Betaferon
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon beta-1b (Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method Rate of discontinuation of Betaferon 24 months
- Secondary Outcome Measures
Name Time Method Number of missed doses of Betaferon 24 months Depression score as measured by CES-D questionnaire 24 months Neurological disability score as measured by EDSS scale 24 months Overall tolerability of treatment as measured by rate of adverse events 24 months