Trial | NCT00534261  Report issue

Title

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®)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    284
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.
Study Started
Nov 30
1999
Study Completion
Feb 29
2004
Last Update
Dec 13
2007
Estimate

Drug Interferon beta-1a

IM injection

1 Experimental

patients received Avonex IM injections and be evaluated for quality of life criteria

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
No Results Posted