Physical Disability in Patients Treated With Betaferon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00873340
First received: March 31, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Multiple Sclerosis
Drug: Interferon-1beta (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate Betaferon safety on the daily routine basis [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
  • To evaluate patient adherence to Betaferon treatment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 83
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MS community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873340

Locations
Colombia
Many Locations, Colombia
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00873340     History of Changes
Other Study ID Numbers: 14173, BF0712CO, 2007- 001 Col
Study First Received: March 31, 2009
Last Updated: June 25, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Bayer:
MS
Multiple Sclerosis
Betaferon
Colombia

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014