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

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Bayer

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study type

Observational

Funder types

Industry

Identifiers

NCT01184833
14323
BF0813PL (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

852 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

852 participants in 1 patient group

Group 1
Treatment:
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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