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NCT Number: NCT00179478

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

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.

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Key information

Conditions

Multiple Sclerosis Acute Brainstem/Cerebellar Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Central Nervous System Infections Cerebellar Diseases Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Infections Myelitis Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuroinflammatory Diseases Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Spinal Cord Diseases Transverse Myelitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vancouver Hospital Health Sciences Centre, Vancouver, British Columbia, Canada

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About this study

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:

  • To determine the long term neurological outcome in patients treated with interferon beta 1a (AVONEX) from onset of a first clinical demyelinating event
  • 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.
  • To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interferon beta 1a 30 ug IM once weekly

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Annualized Relapse Rate

    Time frame: 10 years

    annualized # of relapses between years 0 and 10

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Biogen

Registry information

Official study title

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

Acronym: CHAMPIONS10

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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