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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Optic Neuritis
Transverse Myelitis
Acute Brainstem/Cerebellar Syndrome
Drug: interferon beta 1a 30 ug IM once weekly
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS)

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Rate of development of clinical definite multiple sclerosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 203
Study Start Date: February 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.

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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179478

  Show 26 Study Locations
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Biogen Idec
Investigators
Principal Investigator: Revere P Kinkel, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Revere P Kinkel MD/ Division Chief Section on Demyelinating Diseases, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179478     History of Changes
Other Study ID Numbers: 2003-P-000086, C-850 Extension study
Study First Received: September 12, 2005
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Beth Israel Deaconess Medical Center:
Multiple sclerosis
Interferon Beta
MRI
Optic neuritis
Transverse Myelitis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Cerebellar Diseases
Myelitis
Myelitis, Transverse
Neuritis
Optic Neuritis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014