Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance (CHAMPIONS CONT)

Approximately 383 patients participated in CHAMPS, the original AVONEX® placebo trial, will be approached for study participation. The patient population will be divided into two cohorts.

Cohort 1: Patients that participated in CHAMPS and CHAMPIONS 10 will be approached for study participation at approximately twenty-four CHAMPIONS Continuation investigative sites. Patients were diagnosed upon entry into CHAMPS with CIS demyelinating event with MRI lesions consistent with MS. Patients are eligible regardless of whether they have converted to Clinically Definite Multiple Sclerosis (CDMS) or not. Cohort 1 patients will have annual EDSS, self-report EDSS, medication review and relapse recalculation. SF-36 and SDMT assessments will be performed at years 1 and 5 during routine office visits. A MRI will be performed each patient's 15 year anniversary date. See Schedule of Assessments, section 12.

Cohort 2: Patients that participated in CHAMPS will be located and approached for s

Inclusion Criteria:

• Patients are eligible to be screened for this study if all of the following criteria are met:

  1. All patients must have been originally enrolled in CHAMPS, regardless of randomization arm. Only Cohort 1 patients must have been enrolled in CHAMPIONS 10.
  2. Willing and able to provide informed consent (Cohort 1), waiver of informed consent (Cohort 2), or reported patient death through public database search.
  3. Ability to read and write English (patient reported assessment tools are in English only).

Exclusion Criteria:

• Candidates will be excluded from study screening if any of the following exclusion criteria exist:

  1. Patients not participating in the original CHAMPS study.
  2. Alternative diagnosis to MS discovered.
  3. Patient unwilling or unable to provide informed consent (Cohort 1) or waiver of informed consent (Cohort 2), as applicable.
  4. 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.