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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01184833
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : June 25, 2013
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Brief 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.

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

Study Type : Observational
Actual Enrollment : 852 participants
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
Study Start Date : September 2008
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Rate of discontinuation of Betaferon [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of missed doses of Betaferon [ Time Frame: 24 months ]
  2. Depression score as measured by CES-D questionnaire [ Time Frame: 24 months ]
  3. Neurological disability score as measured by EDSS scale [ Time Frame: 24 months ]
  4. Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01184833

Many Locations, Poland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Sp. z o.o. Identifier: NCT01184833     History of Changes
Other Study ID Numbers: 14323
BF0813PL ( Other Identifier: company internal )
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

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

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