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CompletedNCT00873340Updated Jun 26, 2014

Physical Disability in Patients Treated With Betaferon

An observational study in Multiple Sclerosis, sponsored by Bayer. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
83
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • MS
  • Multiple Sclerosis
  • Betaferon
  • Colombia
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 83 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

MS community sample

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
83 participants (actual)

Groups and cohorts

  • Group 1

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

Interventions

  • DrugInterferon-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.

06

What researchers measure

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

07

Study locations

1 site
  • Many Locations, Colombia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00873340
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Apr 1, 2009
Start date
Oct 2007
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Jun 26, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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