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OpenTrials
Completed

NCT Number: NCT00873340

Physical Disability in Patients Treated With Betaferon

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon-1beta (Betaseron, BAY86-5046)

Drug

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 observed.

Primary outcomes

  1. To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon

    Time frame: Every 6 months for 2 years

Secondary outcomes

  1. To evaluate Betaferon safety on the daily routine basis

    Time frame: Every 6 months

  2. To evaluate patient adherence to Betaferon treatment

    Time frame: Every 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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