- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534261
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a? (FLAIR)
December 11, 2007 updated by: Biogen
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®)
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
284
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sijsele-Damme, Belgium, 8340
- Coordinating Research Site
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Esch-Sur-Alzette, Luxembourg, 4011
- Coordinating Research Site
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Scotland
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Glasgow, Scotland, United Kingdom
- Coordinating Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
patients received Avonex IM injections and be evaluated for quality of life criteria
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IM injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Reproducibility of Quality of Life scales per language version
Time Frame: months 18 and 24
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months 18 and 24
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Reliability of the Quality of Life scales per language version
Time Frame: months 18 and 24
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months 18 and 24
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EDSS score throughout the study
Time Frame: screening, Day -1, Months 12 and 24
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screening, Day -1, Months 12 and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Biogen-Idec Investigator, neurologyclinicaltrials@biogenidec.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1999
Study Completion (Actual)
February 1, 2004
Study Registration Dates
First Submitted
September 21, 2007
First Submitted That Met QC Criteria
September 21, 2007
First Posted (Estimate)
September 24, 2007
Study Record Updates
Last Update Posted (Estimate)
December 13, 2007
Last Update Submitted That Met QC Criteria
December 11, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon beta-1a
- Interferon-beta
Other Study ID Numbers
- BIO-BNL 99-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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