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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

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