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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The current study is an extension of the previous 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 continues to delay the development of further attacks and the development of neurological disability over a 10 year period of observation.

Detailed Summary:

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

Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: Rate of development of clinical definite multiple sclerosis [ Time Frame: 10 years ]

Original Primary Outcome: 1. The rate of development of clinical definite multiple sclerosis over 10 years

Current Secondary Outcome:

  • Annualized relapse rates [ Time Frame: 10 years ]
  • The development of neurological disability as measured by the Expanded Disability Status Score (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 10 years ]
  • The development of new or enlarging T2 lesions and change in T2 lesion volume [ Time Frame: 10 years ]
  • Change in Brain Parenchymal Fraction . [ Time Frame: 5 and 10 years ]
  • Quality of life (SF36 and MSQLI). [ Time Frame: 10 years ]


Original Secondary Outcome:

  • 1. Annualized relapse rates over 10 years
  • 2. The development of neurological disability as measured by the Expanded Disability Status Score (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) over 10 years
  • 3. The development of new or enlarging T2 lesions and change in T2 lesion volume at 5 and 10 years.
  • 4. Change in Brain Parenchymal Fraction at 5 and 10 years.
  • 5. Quality of life (SF36 and MSQLI) over 10 years.


Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: September 12, 2005
Date Started: February 2001
Date Completion:
Last Updated: June 22, 2011
Last Verified: June 2011