Physical Disability in Patients Treated With Betaferon

NCT ID: NCT00873340

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Interferon-1beta (Betaseron, BAY86-5046)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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BF0712CO

Identifier Type: OTHER

Identifier Source: secondary_id

2007- 001 Col

Identifier Type: OTHER

Identifier Source: secondary_id

14173

Identifier Type: -

Identifier Source: org_study_id

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