Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
NCT ID: NCT01184833
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
852 participants
OBSERVATIONAL
2008-09-30
2011-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
Interventions
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Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
Eligibility Criteria
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Inclusion Criteria
* Age \>/= 18 years
* Start of treatment with Betaferon not earlier than 60 days prior to inclusion
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Sp. z o.o.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Poland
Countries
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Other Identifiers
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BF0813PL
Identifier Type: OTHER
Identifier Source: secondary_id
14323
Identifier Type: -
Identifier Source: org_study_id
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