Trial Condition(s):
Multiple Sclerosis
Evaluation of risk factors for early termination of injection treatment with Betaferon in patients suffering from multiple sclerosis (BREAK)
Bayer Identifier:
14323
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evaluation of risk factors for premature discontinuation of injection treatment with Betaferon in patients with relapsing forms of multiple sclerosis
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Rate of discontinuation of BetaferonTimeframe: 24 months
Secondary Outcome
- Number of missed doses of BetaferonTimeframe: 24 months
- Depression score as measured by CES-D questionnaireTimeframe: 24 months
- Neurological disability score as measured by EDSS scaleTimeframe: 24 months
- Overall tolerability of treatment as measured by rate of adverse eventsTimeframe: 24 months
Additional Information
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