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®)

CompletedPhase 4Relapsing MSNCT00534261

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

What it measured

Main measures

  • 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

    Quality of life (reported by participants)Immune response

Other measures (3)

  • Reproducibility of Quality of Life scales per language version

    months 18 and 24

    Quality of life (reported by participants)
  • Reliability of the Quality of Life scales per language version

    months 18 and 24

    Quality of life (reported by participants)
  • EDSS score throughout the study

    screening, Day -1, Months 12 and 24

    Disability progression

Who could take part

Relapsing MS · 18 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Related trials

History

    1. Started

      Nov 1999

    2. Finished

      Feb 2004

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