- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873340
Physical Disability in Patients Treated With Betaferon
June 25, 2014 updated by: Bayer
Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many Locations, Colombia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MS community sample
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Every 6 months for 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate Betaferon safety on the daily routine basis
Time Frame: Every 6 months
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Every 6 months
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To evaluate patient adherence to Betaferon treatment
Time Frame: Every 6 months
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Every 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 1, 2009
Study Record Updates
Last Update Posted (Estimate)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 25, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon beta-1b
Other Study ID Numbers
- 14173
- BF0712CO (Other Identifier: company internal)
- 2007- 001 Col (Other Identifier: company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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