Status:
TERMINATED
Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-85 years
Brief Summary
Phase IV, multi-center, non-treatment, observational, registry study to determine long term effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.
Detailed Description
The primary objective of this study is to determine the impact of long term AVONEX® treatment on physical status, measured by expanded disability scale score (EDSS), of patients with Multiple Sclerosi...
Eligibility Criteria
Inclusion
- Patients are eligible to be screened for this study if all of the following criteria are met:
- All patients must have been originally enrolled in CHAMPS, regardless of randomization arm. Only Cohort 1 patients must have been enrolled in CHAMPIONS 10.
- Willing and able to provide informed consent (Cohort 1), waiver of informed consent (Cohort 2), or reported patient death through public database search.
- Ability to read and write English (patient reported assessment tools are in English only).
Exclusion
- Candidates will be excluded from study screening if any of the following exclusion criteria exist:
- Patients not participating in the original CHAMPS study.
- Alternative diagnosis to MS discovered.
- Patient unwilling or unable to provide informed consent (Cohort 1) or waiver of informed consent (Cohort 2), as applicable.
- Any other reasons that, in the opinion of the Investigator (Cohort 1) or Patient Coordination Center (Cohort 2), the patient is determined to be unsuitable for enrollment into this study.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01156298
Start Date
June 1 2010
End Date
March 1 2017
Last Update
August 3 2012
Active Locations (1)
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1
Research Site
Buffalo, New York, United States, 14203