Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?
NCT ID: NCT00534261
Last Updated: 2007-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
284 participants
INTERVENTIONAL
1999-11-30
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
patients received Avonex IM injections and be evaluated for quality of life criteria
Interferon beta-1a
IM injection
Interventions
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Interferon beta-1a
IM injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Principal Investigators
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Locations
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Coordinating Research Site
Sijsele-Damme, , Belgium
Coordinating Research Site
Esch-sur-Alzette, , Luxembourg
Coordinating Research Site
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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BIO-BNL 99-01
Identifier Type: -
Identifier Source: org_study_id