Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment (BEACON)

Bayer

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00787657

13852

311941 (Other Identifier)

BF0703 (Other Identifier)

Details and patient eligibility

About

• The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
• The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

Enrollment: 1,723 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.

Exclusion criteria

• Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

Trial design

1,723 participants in 1 patient group

Arm 1

Treatment:

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