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

Brief Title

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

Official Title

Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)

Brief Summary

      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.
    

Detailed Description

      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 site and 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
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years

Secondary Outcome

 Annualized Relapse Rate

Condition

Multiple Sclerosis

Intervention

interferon beta 1a 30 ug IM once weekly

Study Arms / Comparison Groups

 Immediate Treatment Group
Description:  Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

155

Start Date

February 2001

Completion Date

March 2009

Primary Completion Date

March 2009

Eligibility Criteria

        Inclusion Criteria:

          -  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

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Revere P Kinkel, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00179478

Organization ID

2003P000086

Secondary IDs

C-850 Extension study

Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center

Collaborators

 Biogen

Study Sponsor

Revere P Kinkel, MD, Principal Investigator, Beth Israel Deaconess Medical Center


Verification Date

August 2017