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:

NCT01184833

EudraCT Number:

Not Available

Study Completed

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
852
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 

Trial Design