Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Interferon beta-1b, Compliance to treatment, Premature treatment discontinuation
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.
Interventions
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Relapsing-remitting multiple sclerosis * Age \>/= 18 years * Start of treatment with Betaferon not earlier than 60 days prior to inclusion
Exclusion criteria
* Synonymous with contraindications to Betaferon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of discontinuation of Betaferon | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Poland
Outcome results
None listed