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

Phase 4

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: Interferon beta-1a

• Registration Number: NCT00534261
• Lead Sponsor: Biogen

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.

Study Timeline

• Study Start: 1999-11
• Study Completion: 2004-02
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-24
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-11
• Last Update Posted: 2007-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Interferon beta-1a	patients received Avonex IM injections and be evaluated for quality of life criteria

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Coordinating Research Site; 🇬🇧 Glasgow, Scotland, United Kingdom