Status:
COMPLETED
Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Brief Summary
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating o...
Eligibility Criteria
Inclusion
- Provides written informed consent to participate in the study
- 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
- Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01158183
Start Date
July 1 2007
End Date
September 1 2009
Last Update
July 8 2010
Active Locations (27)
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1
Many Locations, Alabama, United States
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Many Locations, California, United States
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Many Locations, Colorado, United States
4
Many Locations, Florida, United States