Avonex 15 Year Long Term Follow-up Study - Full Text View

Purpose

This study will attempt to ascertain whether a treatment difference (early versus delayed treatment) is maintained over an even longer time period, providing further evidence in favor of early treatment of multiple sclerosis. Multiple lines of evidence support the hypothesis that the pathologic process is active early in the course of MS, but progresses without accompanying disability until a threshold is surpassed at a later point in time. Once that threshold is exceeded, clinical disability ensues. For this reason, the actual clinical benefit of early treatment may not be evident for many years after the intervention. There was some suggestion of this phenomenon at the 8-year follow up (more delayed-treatment patients had died from MS-related disability, and the delayed-treatment patients had more disability as measured by EDSS). Given the close relationship of disease progression, disability, and individual independence, it is surmised that differences may be seen in functional independence between the two treatment arms. This study will test the hypothesis that the benefits of early treatment will be increasingly evident with a longer observation period.

Condition	Phase
Multiple Sclerosis	Phase IV

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Interferon beta 1a

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study

Official Title:	Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs

Further study details as provided by Biogen Idec:

Estimated Enrollment:	172
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2007

Detailed Description:

The primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of MS measured by the self-reported EDSS.

Primary endpoints are the following:

Changes in EDSS score from baseline for original Avonex® pivotal trial
Percentage of patients with EDSS > 6
Percentage of patients with EDSS > 7

Secondary objectives are to determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.

Secondary endpoints are:

Percentage of patients alive
Percentage of patients living independently
SF 36 status
Self-reported VAS status

The tertiary objective of this study is to explore the correlation between baseline patients' disease characteristics and long-term disability progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
Signed written informed consent form

Exclusion Criteria:

Unwillingness or inability to comply with the requirements of this protocol.
Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525343

Contacts


Contact: Amber G Bickford, MS	617-914-4923	amber.bickford@biogenidec.com

Locations


United States, District of Columbia
	Georgetown University Medical Center	Not yet recruiting
	Washington, District of Columbia, United States, 20007
	Contact: Krisanna Gusuwan, NP 202-444-3973 kxg127@gunet.georgetown.edu
	Contact: Denise Bartlett 202-444-2658 Bartletd@georgetown.edu
	Principal Investigator: Carlos Tornatore, MD

United States, New York
	Jocab's Neurological Institute	Recruiting
	Buffalo, New York, United States, 14203
	Contact: Terry Justinger 716-859-4125 tjustinger@kaleidahealth.org
	Contact: Kara Patrick, MS 716-859-7510 kpatrick@kaleidahealth.org
	Principal Investigator: Bianca Weinstock-Guttman, MD

United States, Ohio
	Cleveland Clinic Foundation	Not yet recruiting
	Cleveland, Ohio, United States, 44195
	Contact: Diane Ivancic 216-444-5441 IVANCID@ccf.org
	Contact: Claire Hara-Cleaver, RN, MSN 216-445-9418 harac@ccf.org
	Principal Investigator: Rick Rudick, MD
	Sub-Investigator: Rob Bermel, MD

United States, Oregon
	Oregon Health and Science University	Not yet recruiting
	Portland, Oregon, United States, 97239
	Contact: Debbie Griffith, RN 503-494-7651 griffide@ohsu.edu
	Contact: Alison Grossblatt-Wait, MS (503) 494 5077 grossbla@ohsu.edu
	Principal Investigator: Dennis Bourdette, MD

Sponsors and Collaborators

Biogen Idec

Investigators


Study Director:	Pamela Foulds, MD	Biogen Idec

More Information

Study ID Numbers:	007-06-AVX
First Received:	September 4, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00525343
Health Authority:	United States: Institutional Review Board

Keywords provided by Biogen Idec:

Avonex pivotal trial

Avonex

Avonex long term follow-up

Avonex outcomes

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Interferons

Interferon-beta

Interferon beta 1a

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Interferon Alfa-2b

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00525343