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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— 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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534261
• Other study ID #: BIO-BNL 99-01
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2007
• Last updated: December 11, 2007
• Start date: November 1999
• Est. completion date: February 2004

Study information

• Verified date: December 2007
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a
IM injection

Locations

Country	Name	City	State
Belgium	Coordinating Research Site	Sijsele-Damme
Luxembourg	Coordinating Research Site	Esch-Sur-Alzette
United Kingdom	Coordinating Research Site	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Belgium,  Luxembourg,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®).		screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
Secondary	Reproducibility of Quality of Life scales per language version		months 18 and 24
Secondary	Reliability of the Quality of Life scales per language version		months 18 and 24
Secondary	EDSS score throughout the study		screening, Day -1, Months 12 and 24