Clinical trial NCT00534261: Does Quality of Life Improve in Multiple Sclerosis Patients Treated 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Avonex
Interferon beta-1a
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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®).
timeFrame: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
Secondary outcomes:
measure: Reproducibility of Quality of Life scales per language version
timeFrame: months 18 and 24
measure: Reliability of the Quality of Life scales per language version
timeFrame: months 18 and 24
measure: EDSS score throughout the study
timeFrame: screening, Day -1, Months 12 and 24
Other outcomes:
Locations:
city: Sijsele-Damme
country: Belgium
facility: Coordinating Research Site
city: Esch-Sur-Alzette
country: Luxembourg
facility: Coordinating Research Site
city: Glasgow
country: United Kingdom
facility: Coordinating Research Site
state: Scotland
Study officials:
affiliation: neurologyclinicaltrials@biogenidec.com
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References: