Physical Disability in Patients Treated With Betaferon

NCT00873340 | Completed

• 3 other identifiers: 14173BF0712CO2007- 001 Col
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

MS; Multiple Sclerosis; Betaferon; Colombia

Outcome Measures

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

  Every 6 months for 2 years

Secondary Outcomes (2)

• To evaluate Betaferon safety on the daily routine basis

  Every 6 months

• To evaluate patient adherence to Betaferon treatment

  Every 6 months

Study Arms (1)

Group 1

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

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS community sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Colombia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: October 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

CO (1)