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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00534261
First received: September 21, 2007
Last updated: December 11, 2007
Last verified: December 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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®)

Resource links provided by NLM:

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
Experimental: 1
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
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

ClinicalTrials.gov Identifier: NCT00534261     History of Changes
Other Study ID Numbers: BIO-BNL 99-01
Study First Received: September 21, 2007
Last Updated: December 11, 2007
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:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 19, 2013