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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01184833
First received: August 18, 2010
Last updated: April 27, 2012
Last verified: April 2012
History of Changes

August 18, 2010
April 27, 2012
September 2008
Not Provided
Rate of discontinuation of Betaferon [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01184833 on ClinicalTrials.gov Archive Site
  • Number of missed doses of Betaferon [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Depression score as measured by CES-D questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Neurological disability score as measured by EDSS scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Multiple Sclerosis
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.
Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
848
December 2011
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01184833
14323, BF0813PL
No
Medical Director, Bayer Sp. z o.o.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP