Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— BREAK  

Official title:

Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184833
• Other study ID #: 14323
• Secondary ID: BF0813PL
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: June 24, 2013
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of discontinuation of Betaferon		24 months	No
Secondary	Number of missed doses of Betaferon		24 months	No
Secondary	Depression score as measured by CES-D questionnaire		24 months	Yes
Secondary	Neurological disability score as measured by EDSS scale		24 months	No
Secondary	Overall tolerability of treatment as measured by rate of adverse events		24 months	Yes

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