Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
NCT ID: NCT01158183
Last Updated: 2010-07-08
Study Results
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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COMPLETED
226 participants
OBSERVATIONAL
2007-07-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
No intervention
BAY86-5046_Interferon-beta-1b
Electronic questionnaires
Interventions
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BAY86-5046_Interferon-beta-1b
Electronic questionnaires
Eligibility Criteria
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Inclusion Criteria
* At least 18 but no more than 65 years old
* Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
* Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
* Willing and able to provide a valid e-mail address which will be in use for the duration of the study
* Willing and able to complete study questionnaires via the Internet
* Has reliable Internet access for the duration of the study
* Completes the baseline patient questionnaire
Exclusion Criteria
* Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
* Any use of Betaseron within the three months prior to study entry
* Inability to read, write, or speak the English language
* Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
* Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life
* Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon
* Current use of any immunosuppressive medication
* Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry
* Previous use of monoclonal antibodies treating MS within the three months prior to study entry
* Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
18 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare Pharmaceuticals Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, Alabama, United States
Many Locations, California, United States
Many Locations, Colorado, United States
Many Locations, Florida, United States
Many Locations, Illinois, United States
Many Locations, Iowa, United States
Many Locations, Kansas, United States
Many Locations, Louisiana, United States
Many Locations, Maine, United States
Many Locations, Massachusetts, United States
Many Locations, Michigan, United States
Many Locations, Missouri, United States
Many Locations, Nevada, United States
Many Locations, New Hampshire, United States
Many Locations, New Jersey, United States
Many Locations, New York, United States
Many Locations, North Carolina, United States
Many Locations, North Dakota, United States
Many Locations, Ohio, United States
Many Locations, Oregon, United States
Many Locations, Pennsylvania, United States
Many Locations, Rhode Island, United States
Many Locations, Tennessee, United States
Many Locations, Texas, United States
Many Locations, Virginia, United States
Many Locations, Washington, United States
Many Locations, Wisconsin, United States
Countries
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Other Identifiers
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BF0714US
Identifier Type: -
Identifier Source: secondary_id
311644
Identifier Type: -
Identifier Source: secondary_id
14838
Identifier Type: -
Identifier Source: org_study_id
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