Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period (SEPLUS)

Bayer

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01076595

BF0910FR (Other Identifier)

15098

Details and patient eligibility

About

The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female >/= 18 years old
• Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event
• Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study
• Treatment naïve patients before the initiation of Betaferon
• OR Patients having interrupted Betaferon for more than 6 months before to start again
• OR Patients receiving a disease modifying drug (DMD) other than Betaferon
• Patient with EDSS score < 4
• Patients approved and signed an inform consent and approved the collect of their data

Exclusion criteria

• Contraindications and warning of the respective Summary of Product Characteristics

Trial design

73 participants in 1 patient group

Group 1

Treatment:

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