Physical Disability in Patients Treated With Betaferon
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: Interferon-1beta (Betaseron, BAY86-5046)
- Registration Number
- NCT00873340
- Lead Sponsor
- Bayer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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.
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon-1beta (Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon Every 6 months for 2 years
- Secondary Outcome Measures
Name Time Method To evaluate Betaferon safety on the daily routine basis Every 6 months To evaluate patient adherence to Betaferon treatment Every 6 months