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

NCT01156298 | Terminated

• 1 other identifier: 004-09-AVX
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• EDSS

  yearly

• MRI

  last visit, 15 year anniversary

Secondary Outcomes (2)

• Quality of Life

  year 1 & 5

• Symbol Digit Modality Test

  year 1 & 5

Study Arms (2)

Cohort 1

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.

Cohort 2

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. Patients will be waiving written informed consent and asked to provide concomitant medication, self-reported EDSS, and SF-36 only.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

US (1)