Physical Disability in Patients Treated With Betaferon

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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