Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	Biogen Idec
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179478

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 IV

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:

MedlinePlus related topics: Multiple Sclerosis

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

U.S. FDA Resources

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.

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:

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

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

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:

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.

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:

Cerebellar Diseases
Multiple Sclerosis
Myelitis
Myelitis, Transverse
Neuritis
Optic Neuritis
Sclerosis
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 February 09, 2012