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

Multiple Sclerosis Clinical Trial

— CHAMPIONS10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179478
• Other study ID #: 2003-P-000086
• Secondary ID: C-850 Extension
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: June 22, 2011
• Start date: February 2001
• Est. completion date: March 2009

Study information

• Verified date: June 2011
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Brainstem/Cerebellar Syndrome
• Cerebellar Diseases
• Multiple Sclerosis
• Myelitis
• Myelitis, Transverse
• Neuritis
• Optic Neuritis
• Sclerosis
• Transverse Myelitis

Intervention

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.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Hospital Notre Dame	Montreal	Quebec
Canada	Montreal Neurological Institute	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	University of Toronto - St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver Hospital Health Sciences Centre	Vancouver	British Columbia
United States	MS Center of Atlanta	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Jacobs Neurological Institute	Buffalo	New York
United States	Carolinas Medical Center - MS Center	Charlotte	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	MS Treatment Center at Griffin Hospital	Derby	Connecticut
United States	Michigan State University	East Lansing	Michigan
United States	Beta Research, Inc	Elk Grove	Illinois
United States	Univeristy of Texas Houston Health Science Center	Houston	Texas
United States	University of Iowa College of Medicine	Iowa City	Iowa
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	The Neurology Group	Norristown	Pennsylvania
United States	Univeristy of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Allegheny Neurological Associates	Pittsburgh	Pennsylvania
United States	Neurological Associates, Inc.	Richmond	Virginia
United States	Virginia Commonwealth University/Medical College of Virginia	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	St. Louis University Health Sciences Center	St. Louis	Missouri
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Biogen

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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. Epub 2006 Jan 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of development of clinical definite multiple sclerosis		10 years	No
Secondary	Annualized relapse rates		10 years	No
Secondary	The development of neurological disability as measured by the Expanded Disability Status Score (EDSS) and the Multiple Sclerosis Functional Composite (MSFC)		10 years	No
Secondary	The development of new or enlarging T2 lesions and change in T2 lesion volume		10 years	No
Secondary	Change in Brain Parenchymal Fraction .		5 and 10 years	No
Secondary	Quality of life (SF36 and MSQLI).		10 years	No