Know Cancer

forgot password

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

Phase 4
18 Years
Not Enrolling
Multiple Sclerosis, Optic Neuritis, Transverse Myelitis, Acute Brainstem/Cerebellar Syndrome

Thank you

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

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

Inclusion Criteria:

- Previous participation in CHAMPS study

- Willingness to enroll prior to 5 year visit

- Willingness to sign informed consent

Exclusion Criteria:

- Discovery of an alternative neurological disorder other than MS as a cause of initial
neurological symptoms

- A severe systemic disease with likely mortality within 3 years

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of development of clinical definite multiple sclerosis

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Revere P Kinkel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2001

Completion Date:

March 2009

Related Keywords:

  • Multiple Sclerosis
  • Optic Neuritis
  • Transverse Myelitis
  • Acute Brainstem/Cerebellar Syndrome
  • Multiple sclerosis
  • Interferon Beta
  • MRI
  • Optic neuritis
  • Transverse Myelitis
  • Cerebellar Diseases
  • Multiple Sclerosis
  • Myelitis
  • Myelitis, Transverse
  • Neuritis
  • Optic Neuritis
  • Sclerosis



Cleveland Clinic Foundation Cleveland, Ohio  44195
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Marshfield Clinic Marshfield, Wisconsin  54449
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Michigan State University East Lansing, Michigan  48824
University of Iowa College of Medicine Iowa City, Iowa  52242
University of Rochester Rochester, New York  14642
The Ohio State University Columbus, Ohio  43210
MS Treatment Center at Griffin Hospital Derby, Connecticut  06418
Jaeb Center for Health Research Tampa, Florida  33647
MS Center of Atlanta Atlanta, Georgia  30327
Beta Research, Inc Elk Grove, Illinois  60007
Jacobs Neurological Institute Buffalo, New York  14203
Carolinas Medical Center - MS Center Charlotte, North Carolina  28207
The Neurology Group Norristown, Pennsylvania  19401
Univeristy of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104
Allegheny Neurological Associates Pittsburgh, Pennsylvania  15212
Univeristy of Texas Houston Health Science Center Houston, Texas  77030
Virginia Commonwealth University/Medical College of Virginia Richmond, Virginia  23219
Neurological Associates, Inc. Richmond, Virginia  23230