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

Study Description

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.

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

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:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	155 participants
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
Official Title:	Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)
Study Start Date :	February 2001
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	March 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon beta Interferon beta-1a Avonex

Genetic and Rare Diseases Information Center resources: Myelitis Transverse Myelitis Optic Neuritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	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 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	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.

Arm

Intervention/treatment

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

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 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

Drug: interferon beta 1a 30 ug IM once weekly

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179478

Locations

Show 26 study locations

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United States, Connecticut
MS Treatment Center at Griffin Hospital
Derby, Connecticut, United States, 06418
United States, Florida
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Georgia
MS Center of Atlanta
Atlanta, Georgia, United States, 30327
United States, Illinois
Beta Research, Inc
Elk Grove, Illinois, United States, 60007
United States, Iowa
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110
United States, New York
Jacobs Neurological Institute
Buffalo, New York, United States, 14203
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center - MS Center
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
The Neurology Group
Norristown, Pennsylvania, United States, 19401
Univeristy of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Univeristy of Texas Houston Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University/Medical College of Virginia
Richmond, Virginia, United States, 23219
Neurological Associates, Inc.
Richmond, Virginia, United States, 23230
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, British Columbia
Vancouver Hospital Health Sciences Centre
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
University of Toronto - St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hospital Notre Dame
Montreal, Quebec, Canada, H2l 4M1
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Biogen

Investigators

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Principal Investigator:	Revere P Kinkel, MD	Beth Israel Deaconess Medical Center

More Information

Publications:

Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med. 2000 Sep 28;343(13):898-904.

Kinkel RP, Kollman C, O'Connor P, Murray TJ, Simon J, Arnold D, Bakshi R, Weinstock-Gutman B, Brod S, Cooper J, Duquette P, Eggenberger E, Felton W, Fox R, Freedman M, Galetta S, Goodman A, Guarnaccia J, Hashimoto S, Horowitz S, Javerbaum J, Kasper L, Kaufman M, Kerson L, Mass M, Rammohan K, Reiss M, Rolak L, Rose J, Scott T, Selhorst J, Shin R, Smith C, Stuart W, Thurston S, Wall M; CHAMPIONS Study Group. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology. 2006 Mar 14;66(5):678-84. Epub 2006 Jan 25.

Kinkel RP, Dontchev M, Kollman C, Skaramagas TT, O'Connor PW, Simon JH; Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance Investigators. Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance. Arch Neurol. 2012 Feb;69(2):183-90. doi: 10.1001/archneurol.2011.1426. Epub 2011 Oct 10.

Simon JH, Kinkel RP, Kollman C, O'Connor P, Fisher E, You X, Hyde R; CHAMPIONS Investigators Group. Ten-year follow-up of the 'minimal MRI lesion' subgroup from the original CHAMPS Multiple Sclerosis Prevention Trial. Mult Scler. 2015 Apr;21(4):415-22. doi: 10.1177/1352458514547407. Epub 2014 Oct 24.

Kinkel RP, Laforet G, You X. Disease-related determinants of quality of life 10 years after clinically isolated syndrome. Int J MS Care. 2015 Jan-Feb;17(1):26-34. doi: 10.7224/1537-2073.2013-041.

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Responsible Party:	R. Philip Kinkel, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179478
Other Study ID Numbers:	2003P000086 C-850 Extension study ( Other Identifier: Biogen Inc )
First Posted:	September 16, 2005 Key Record Dates
Results First Posted:	September 6, 2017
Last Update Posted:	September 6, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by R. Philip Kinkel, Beth Israel Deaconess Medical Center:


Multiple sclerosis Interferon Beta MRI Optic neuritis Transverse Myelitis

Additional relevant MeSH terms:

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Myelitis Myelitis, Transverse Multiple Sclerosis Neuritis Optic Neuritis Cerebellar Diseases Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases	Neuromuscular Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Central Nervous System Infections Infections Central Nervous System Diseases Spinal Cord Diseases Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Neurodegenerative Diseases Brain Diseases

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