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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
  Purpose

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.


Condition Intervention
Multiple Sclerosis
 Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Rate of discontinuation of Betaferon [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 848
Study Start Date: September 2008
Study Completion Date: December 2011
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184833

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o.
ClinicalTrials.gov Identifier: NCT01184833     History of Changes
Other Study ID Numbers: 14323, BF0813PL
Study First Received: August 18, 2010
Last Updated: April 27, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Multiple sclerosis
Interferon beta-1b
Compliance to treatment
Premature treatment discontinuation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013