Clinical trial NCT00179478: Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Official title: Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Optic Neuritis
Transverse Myelitis
Acute Brainstem/Cerebellar Syndrome
Keywords: Multiple sclerosis
Interferon Beta
MRI
Optic neuritis
Transverse Myelitis
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-09-16
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
timeFrame: 10 years
Secondary outcomes:
measure: Annualized Relapse Rate
timeFrame: 10 years
measure: Number of Participants With an EDSS > 3.5 at Study Completion
timeFrame: 10 years
measure: The Number of New or Enlarging MRI T2 Lesions at 10 Years
timeFrame: 10 years
Other outcomes:
Locations:
city: Derby
country: United States
facility: MS Treatment Center at Griffin Hospital
state: Connecticut
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
city: Atlanta
country: United States
facility: MS Center of Atlanta
state: Georgia
city: Elk Grove
country: United States
facility: Beta Research, Inc
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa College of Medicine
state: Iowa
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Buffalo
country: United States
facility: Jacobs Neurological Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center - MS Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Norristown
country: United States
facility: The Neurology Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: Univeristy of Texas Houston Health Science Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University/Medical College of Virginia
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates, Inc.
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver Hospital Health Sciences Centre
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto - St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Revere P Kinkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJM200009283431301.
citation: 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. doi: 10.1212/01.wnl.0000200778.65597.ae. Epub 2006 Jan 25.
citation: 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.
citation: 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.
citation: 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.