Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance

Stopped early

Conditions studied: Multiple Sclerosis

In brief

Phase IV, multi-center, non-treatment, observational, registry study to determine long term effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.

Key facts

Study ID

NCT01156298

Run by

Biogen

People needed

383

Starts

2010-06-01

Expected to finish

2017-03-01

Last updated by the study team

2012-08-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Research Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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