Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis

Completed · Phase 4 · Has a placebo group

Conditions studied: Multiple Sclerosis, Optic Neuritis, Transverse Myelitis, Acute Brainstem/Cerebellar Syndrome

In brief

The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.

Key facts

Study ID

NCT00179478

Run by

Beth Israel Deaconess Medical Center

People needed

155

Starts

2001-02-01

Expected to finish

2009-03-01

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous participation in CHAMPS study
• Participation in a study site willing to participate in the CHAMPIONS10 extension study
• Willingness to enroll in the CHAMPIONS 10 extension
• Willingness to sign informed consent

You may not qualify if…

• 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

Where it is running

• MS Treatment Center at Griffin Hospital — Derby, Connecticut, United States
• Jaeb Center for Health Research — Tampa, Florida, United States
• MS Center of Atlanta — Atlanta, Georgia, United States
• Beta Research, Inc — Elk Grove, Illinois, United States
• University of Iowa College of Medicine — Iowa City, Iowa, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States
• St. Louis University Health Sciences Center — St Louis, Missouri, United States
• Jacobs Neurological Institute — Buffalo, New York, United States
• University of Rochester — Rochester, New York, United States
• Carolinas Medical Center - MS Center — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• The Neurology Group — Norristown, Pennsylvania, United States
• Univeristy of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Allegheny Neurological Associates — Pittsburgh, Pennsylvania, United States
• Univeristy of Texas Houston Health Science Center — Houston, Texas, United States
• Virginia Commonwealth University/Medical College of Virginia — Richmond, Virginia, United States
• Neurological Associates, Inc. — Richmond, Virginia, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Vancouver Hospital Health Sciences Centre — Vancouver, British Columbia, Canada
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• Ottawa General Hospital — Ottawa, Ontario, Canada
• University of Toronto - St. Michael's Hospital — Toronto, Ontario, Canada
• Hospital Notre Dame — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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