Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Bayer

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00902135

BF0801DE (Other Identifier)

14543

Details and patient eligibility

About

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

Enrollment: 702 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion criteria

• Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
• Exclusion criteria must be read in conjunction with the German product information.

Trial design

702 participants in 3 patient groups

Group 1

Treatment:

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

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

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

Group 2

Treatment:

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

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

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

Group 3

Treatment:

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

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

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