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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1a
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Avonex, Interferon beta-1a

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

patients received Avonex IM injections and be evaluated for quality of life criteria

Outcomes

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®).

Secondary Outcome Measures

Reproducibility of Quality of Life scales per language version
Reliability of the Quality of Life scales per language version
EDSS score throughout the study

Full Information

First Posted
September 21, 2007
Last Updated
December 11, 2007
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00534261
Brief Title
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?
Acronym
FLAIR
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Avonex, Interferon beta-1a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients received Avonex IM injections and be evaluated for quality of life criteria
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Intervention Description
IM injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Reproducibility of Quality of Life scales per language version
Time Frame
months 18 and 24
Title
Reliability of the Quality of Life scales per language version
Time Frame
months 18 and 24
Title
EDSS score throughout the study
Time Frame
screening, Day -1, Months 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen-Idec Investigator
Organizational Affiliation
neurologyclinicaltrials@biogenidec.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coordinating Research Site
City
Sijsele-Damme
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Coordinating Research Site
City
Esch-Sur-Alzette
ZIP/Postal Code
4011
Country
Luxembourg
Facility Name
Coordinating Research Site
City
Glasgow
State/Province
Scotland
Country
United Kingdom

12. IPD Sharing Statement

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

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