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Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a? (FLAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00534261
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : December 13, 2007
Sponsor:
Information provided by:
Biogen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Interferon beta-1a Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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®)
Study Start Date : November 1999
Actual Study Completion Date : February 2004

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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00534261


Locations
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Belgium
Coordinating Research Site
Sijsele-Damme, Belgium, 8340
Luxembourg
Coordinating Research Site
Esch-Sur-Alzette, Luxembourg, 4011
United Kingdom
Coordinating Research Site
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Biogen
Investigators
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Principal Investigator: Biogen-Idec Investigator neurologyclinicaltrials@biogenidec.com
More Information
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ClinicalTrials.gov Identifier: NCT00534261    
Other Study ID Numbers: BIO-BNL 99-01
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007
Keywords provided by Biogen:
Multiple Sclerosis
Avonex
Interferon beta-1a
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic