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Costs, Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B (Betaseron)

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ClinicalTrials.gov Identifier: NCT00439257
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the disease process, and progress in understanding the pathogenesis of the inflammatory demyelinating process. The result was to raise new issues in the treatment of the disease, which are then being addressed by studies, including when to initiate treatment and the treatment of partial responders to existing therapies. Paralleling strides in treatment, and of particular importance to the Veterans Administration, was the effectiveness of such therapies, both in terms of cost to the VA Health Care System and quality of life of veterans with multiple sclerosis. This study addressed these issues.

Condition or disease
Multiple Sclerosis

Detailed Description:

Background:

The treatment of multiple sclerosis was evolving in light of specific drug therapies to treat the disease, refinements and acceptance of imaging with MRI to diagnose and monitor the disease process, and progress in understanding the pathogenesis of the inflammatory demyelinating process. The result was to raise new issues in the treatment of the disease, which are then being addressed by studies, including when to initiate treatment and the treatment of partial responders to existing therapies. Paralleling strides in treatment, and of particular importance to the Veterans Administration, was the effectiveness of such therapies, both in terms of cost to the VA Health Care System and quality of life of veterans with multiple sclerosis. This study addressed these issues.

Objectives:

To consider how then currently used drug therapies for MS in veterans, e.g., Interferon beta-1b, interferon beta-1a and glatiramer acetate impact health related quality of life (HRQoL), physical function and disability and use of health care resources within the VA. Comparisons with other groups of veterans with specific chronic medical conditions will be made in order to develop a model of health care utilization based on indices derived from disability and impairment evaluations and HRQoL instruments.

Methods:

One hundred and twenty four veterans with a clinically definite multiple sclerosis at more than 30 VAMCs participated in this observational, prospective study. Prior to starting interferon beta-1b [IFNB-1b: Betaseron (tm)], interferon beta-1a [IFNB-1a: Avonex (tm)] or glatiramer acetate [Copaxone (tm)] baseline assessments were obtained: disability and impairment using the Kurtzke Expanded Disability Status Scale (EDSS) and Functional Scales (FS), and health related quality of life (HRQoL) using a veterans-modified version of the Short Quality of Life scale (SF-36V). Follow-up evaluations were performed at three months and every six months thereafter for three years. Veterans were monitored in terms of changes in their condition, side effects from drugs, and changes in therapies. Health utilization data obtained includes clinic stops, inpatient hospitalizations, cost of medications and supplies, training, referrals for prosthetics, rehabilitative therapies and long term care.

Status:

Completed.


Study Design

Study Type : Observational
Estimated Enrollment : 124 participants
Time Perspective: Prospective
Official Title: Costs, Quality of Life and Functional Outcomes in Veterans Treated for Multiple Sclerosis With Beta-Interferon l-B (Betaseron)
Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veteran enrolled at participating hospitals who have MS and are receiving the drugs of interest.

Exclusion Criteria:

Non-veterans or veterans not meeting the inclusion criteria.

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): NCT00439257


Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Joseph B. Guarnaccia, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Principal Investigator: Robert M. Baumhefner, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00439257     History of Changes
Other Study ID Numbers: SDR 94-001
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs