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

Multiple Sclerosis Clinical Trial

— CHAMPIONS CONT  

Official title:

Phase IV, Multi-center, Non-treatment, Observational, Registry Study to Determine Long Term Effects of AVONEX® Therapy on EDSS, MRI, QoL, and Cognition.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01156298
• Other study ID #: 004-09-AVX
• Status: Terminated
• Phase: N/A
• First received: July 1, 2010
• Last updated: August 2, 2012
• Start date: June 2010
• Est. completion date: March 2017

Study information

• Verified date: August 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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 Sclerosis (MS) after their first clinical event (clinically isolated syndrome) and Magnetic Resonance Imaging (MRI) consistent with MS.

Secondary objectives are to determine the impact of long term therapy with AVONEX® on the following:

a) MRI parameters- new or enlarging T2 lesions, T2 lesion volume, T1 lesion volume, brain parenchymal fraction (BPF) b) Quality of Life (QoL): Heath Status Questionnaire (SF-36) c) Symbol Digit Modality Test (SDMT)

2. To determine the long term impact of therapy on the following in patients treated at the onset of clinically isolated event (CIS)

1. EDSS

2. MRI parameters

3. SF-36

4. SDMT

3. To determine early clinical and MRI predictors of disease progression.

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.

Cohort 2: Patients that participated in CHAMPS will be located and approached for study participation. Patient that participated in CHAMPIONS 10 will not be excluded from Cohort 2. Efforts will be made to potentially locate patients through either the original CHAMPS investigative sites, through the Biogen Idec patient services database, and/or a third party (i.e., patient location service vendor) or some combination of the three. .

For both cohorts, public databases may be utilized for patient reported death.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 383
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Research Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDSS		yearly	No
Primary	MRI		last visit, 15 year anniversary	No
Secondary	Quality of Life		year 1 & 5	No
Secondary	Symbol Digit Modality Test		year 1 & 5	No