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OpenTrials
Completed

NCT Number: NCT00534261

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

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

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coordinating Research Site, Sijsele-Damme, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon beta-1a

Drug

IM injection

Primary outcomes

  1. 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®).

    Time frame: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24

Secondary outcomes

  1. Reproducibility of Quality of Life scales per language version

    Time frame: months 18 and 24

  2. Reliability of the Quality of Life scales per language version

    Time frame: months 18 and 24

  3. EDSS score throughout the study

    Time frame: screening, Day -1, Months 12 and 24

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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®)

Acronym: FLAIR

Important dates

Study start
1999
Study completion
2004
First posted
Sep 24, 2007
Registry last updated
Dec 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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