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