Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a? - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00534261

Purpose

This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Interferon beta-1a	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)

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 Biogen Idec:

Primary Outcome Measures:

The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®). [ Time Frame: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24 ]

Secondary Outcome Measures:

Reproducibility of Quality of Life scales per language version [ Time Frame: months 18 and 24 ]
Reliability of the Quality of Life scales per language version [ Time Frame: months 18 and 24 ]
EDSS score throughout the study [ Time Frame: screening, Day -1, Months 12 and 24 ]

Enrollment:	284
Study Start Date:	November 1999
Study Completion Date:	February 2004

Arms	Assigned Interventions
1: Experimental patients received Avonex IM injections and be evaluated for quality of life criteria	Drug: Interferon beta-1a IM injection

Detailed Description:

The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Relapsing Remitting Multiple Sclerosis
Interferon naïve
Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
Subject has had relapsing MS for > 1 year
Subject has had experienced 2 exacerbations in the last 2 years
Subject had an EDSS [5] score of < 5.5
Subject was ambulant

Exclusion Criteria:

Diagnosis of MS defined as progressive
History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
History of seizures within the 3 months prior to starting this study
History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study
History of intolerance to interferons
Previous use of interferon beta
Female subjects who were pregnant or breast-feeding
For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534261

Locations

Belgium
Coordinating Research Site
Sijsele-Damme, Belgium, 8340
Luxembourg
Coordinating Research Site
Esch-Sur-Alzette, Luxembourg, 4011
United Kingdom, Scotland
Coordinating Research Site
Glasgow, Scotland, United Kingdom

Sponsors and Collaborators

Biogen Idec

Investigators

Principal Investigator:

Biogen-Idec Investigator

neurologyclinicaltrials@biogenidec.com

More Information

No publications provided

Study ID Numbers:	BIO-BNL 99-01
Study First Received:	September 21, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00534261 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:

Multiple Sclerosis
Avonex
Interferon beta-1a

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Interferon beta 1a
Angiogenesis Modulating Agents
Growth Inhibitors
Autoimmune Diseases of the Nervous System

Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Growth Substances
Interferons
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta
Sclerosis
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Demyelinating Autoimmune Diseases, CNS

ClinicalTrials.gov processed this record on November 27, 2009