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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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®)

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1a


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients received Avonex IM injections and be evaluated for quality of life criteria | Drug: Interferon beta-1a<br>* IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of Quality of Life scales per language version |  | months 18 and 24 | 
| Reliability of the Quality of Life scales per language version |  | months 18 and 24 | 
| EDSS score throughout the study |  | screening, Day -1, Months 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avonex, Multiple Sclerosis, Interferon beta-1a