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

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ClinicalTrials.gov Identifier: NCT00179478
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
R. Philip Kinkel, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE April 14, 2017
Results First Posted Date  ICMJE September 6, 2017
Last Update Posted Date September 6, 2017
Study Start Date  ICMJE February 2001
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2017)
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years [ Time Frame: 10 years ]
Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
1. The rate of development of clinical definite multiple sclerosis over 10 years
Change History Complete list of historical versions of study NCT00179478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2017)
  • Annualized Relapse Rate [ Time Frame: 10 years ]
    annualized # of relapses between years 0 and 10
  • Number of Participants With an EDSS > 3.5 at Study Completion [ Time Frame: 10 years ]
    The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.
  • The Number of New or Enlarging MRI T2 Lesions at 10 Years [ Time Frame: 10 years ]
    These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Open label study: The outcome committee determined the primary outcome event (the development of Clinically definite MS) without knowledge of original treatment assignment and the central MRI reading center was not aware of original treatment assignments
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Optic Neuritis
  • Transverse Myelitis
  • Acute Brainstem/Cerebellar Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Immediate Treatment Group
    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 Group
    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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2017)
155
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
203
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00179478
Other Study ID Numbers  ICMJE 2003P000086
C-850 Extension study ( Other Identifier: Biogen Inc )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party R. Philip Kinkel, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Biogen
Investigators  ICMJE
Principal Investigator: Revere P Kinkel, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date August 2017

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