Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis (CHAMPIONS10)

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179478
First received: September 12, 2005
Last updated: June 22, 2011
Last verified: June 2011

September 12, 2005
June 22, 2011
February 2001
March 2009   (final data collection date for primary outcome measure)
Rate of development of clinical definite multiple sclerosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
1. The rate of development of clinical definite multiple sclerosis over 10 years
Complete list of historical versions of study NCT00179478 on ClinicalTrials.gov Archive Site
  • Annualized relapse rates [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The development of new or enlarging T2 lesions and change in T2 lesion volume [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Change in Brain Parenchymal Fraction . [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]
  • Quality of life (SF36 and MSQLI). [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS)

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Optic Neuritis
  • Transverse Myelitis
  • Acute Brainstem/Cerebellar Syndrome
Drug: interferon beta 1a 30 ug IM once weekly
Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.
  • Experimental: Immediate Treatment
    Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals
    Intervention: Drug: interferon beta 1a 30 ug IM once weekly
  • Active Comparator: Delayed Treatment
    Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation
    Intervention: Drug: interferon beta 1a 30 ug IM once weekly

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00179478
2003-P-000086, C-850 Extension study
Yes
Revere P Kinkel MD/ Division Chief Section on Demyelinating Diseases, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Biogen Idec
Principal Investigator: Revere P Kinkel, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP