Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Rate of discontinuation of Betaferon
Secondary outcome: Number of missed doses of BetaferonDepression score as measured by CES-D questionnaire Neurological disability score as measured by EDSS scale Overall tolerability of treatment as measured by rate of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Many Locations, Poland
Additional Information
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Starting date: September 2008
Last updated: June 24, 2013
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