Physical Disability in Patients Treated With Betaferon

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873340
• Other study ID #: 14173
• Secondary ID: BF0712CO2007- 00
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: June 25, 2014
• Start date: October 2007
• Est. completion date: January 2011

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate Betaferon safety on the daily routine basis		Every 6 months	Yes
Secondary	To evaluate patient adherence to Betaferon treatment		Every 6 months	No

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