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

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Interferon beta-1a (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen Idec

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: neurologyclinicaltrials@biogenidec.com

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

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: 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:

Reproducibility of Quality of Life scales per language version

Reliability of the Quality of Life scales per language version

EDSS score throughout the study

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Coordinating Research Site, Sijsele-Damme 8340, Belgium

Coordinating Research Site, Esch-Sur-Alzette 4011, Luxembourg

Coordinating Research Site, Glasgow, Scotland, United Kingdom

Starting date: November 1999
Ending date: February 2004
Last updated: December 11, 2007