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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 Betaferon

Depression 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

Page last updated: August 20, 2015

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