Trial Information

Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS)

The CHAMPS study determined that immediate initiation of interferon beta 1a therapy (AVONEX)
immediately following a first clinical demyelinating event in high risk patients (i.e. those
with at least 2 asymptomatic white matter lesions on cranial MR imaging > 3 mm in diameter
or ovoid) delayed the development of clinical definite Multiple Sclerosis (CDMS)(as defined
by a second, clinically verifiable attack involving another part of the central nervous
system) over 2 years of observation and significantly decreased the development of new or
enlarging white matter lesions on MRI over 18 months (see reference). The current study is a
long term extension of a cohort of CHAMPS study participants. The three main aims of the
study are as follows:

1. To determine the long term neurological outcome in patients treated with interferon
beta 1a (AVONEX) from onset of a first clinical demyelinating event

2. To determine if immediate initiation of AVONEX therapy (the CHAMPS Avonex treatment
group) confers long term benefits compared to delayed initiation of therapy (the CHAMPS
placebo group) on the rate of development of CDMS, annualized relapse rates, the
development of permanent disability and MR measures of disease activity and
progression.

3. To determine predictors of long term disease activity and disability in patients
following a first clinical demyelinating event