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

Phase 4

Completed

• Conditions: Optic Neuritis; Transverse Myelitis; Acute Brainstem/Cerebellar Syndrome; Multiple Sclerosis
• Interventions: Drug: interferon beta 1a 30 ug IM once weekly

• Registration Number: NCT00179478
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Timeline

• Study Start: 2001-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2017-04-14
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-06
• Last Update Submitted: 2017-08-06
• Results First Posted: 2017-09-06
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Treatment Group	interferon beta 1a 30 ug IM once weekly	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
Immediate Treatment Group	interferon beta 1a 30 ug IM once weekly	Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

Primary Outcome Measures

Name	Time	Method
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years	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 Outcome Measures

Name	Time	Method
Annualized Relapse Rate	10 years	annualized # of relapses between years 0 and 10
Number of Participants With an EDSS > 3.5 at Study Completion	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	10 years	These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity

Trial Locations

Locations (26)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

St. Louis University Health Sciences Center; 🇺🇸 Saint Louis, Missouri, United States

Carolinas Medical Center - MS Center; 🇺🇸 Charlotte, North Carolina, United States

The Neurology Group; 🇺🇸 Norristown, Pennsylvania, United States

Jacobs Neurological Institute; 🇺🇸 Buffalo, New York, United States

MS Treatment Center at Griffin Hospital; 🇺🇸 Derby, Connecticut, United States

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Beta Research, Inc; 🇺🇸 Elk Grove, Illinois, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Hospital Notre Dame; 🇨🇦 Montreal, Quebec, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

University of Iowa College of Medicine; 🇺🇸 Iowa City, Iowa, United States

Vancouver Hospital Health Sciences Centre; 🇨🇦 Vancouver, British Columbia, Canada

Montreal Neurological Institute; 🇨🇦 Montreal, Quebec, Canada

Jaeb Center for Health Research; 🇺🇸 Tampa, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

MS Center of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Univeristy of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Allegheny Neurological Associates; 🇺🇸 Pittsburgh, Pennsylvania, United States

Marshfield Clinic; 🇺🇸 Marshfield, Wisconsin, United States

University of Toronto - St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Univeristy of Texas Houston Health Science Center; 🇺🇸 Houston, Texas, United States

Virginia Commonwealth University/Medical College of Virginia; 🇺🇸 Richmond, Virginia, United States

Neurological Associates, Inc.; 🇺🇸 Richmond, Virginia, United States