Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance
Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Phase: N/A
Status: Terminated
Sponsored by: Biogen
Summary
Phase IV, multi-center, non-treatment, observational, registry study to determine long term
effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.
Clinical Details
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.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: EDSSMRI
Secondary outcome: Quality of LifeSymbol Digit Modality Test
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Research Site, Buffalo, New York 14203, United States
Additional Information
Starting date: June 2010
Last updated: August 2, 2012
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