Physical Disability in Patients Treated With Betaferon

Bayer

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00873340

14173

2007- 001 Col (Other Identifier)

BF0712CO (Other Identifier)

Details and patient eligibility

About

To gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.

Exclusion criteria

• Pregnancy
• Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients
• Patients with a history of severe depressive disorders and/or suicidal ideation
• Patient with decompensated liver disease
• Patient with epilepsy not adequately controlled by treatment

Trial design

83 participants in 1 patient group

Group 1

Treatment:

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