Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study (AVAIL)

October 16, 2015 updated by: Biogen

A Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been Initiated

The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Research Site
    • Antwerp
      • Bonheiden, Antwerp, Belgium, 2820
        • Research Site
      • Middelheim, Antwerp, Belgium, 2020
        • Research Site
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Research Site
    • Bruxelles
      • Woluwe, Bruxelles, Belgium, 1200
        • Research Site
    • East Flanders
      • Aalst, East Flanders, Belgium, 9300
        • Research Site
      • St Niklaas, East Flanders, Belgium, 9100
        • Research Site
      • Tielt, East Flanders, Belgium, 8700
        • Research Site
    • Hainaut
      • Baudour, Hainaut, Belgium, 7331
        • Research Site
      • Charleroi, Hainaut, Belgium, 6000
        • Research Site
      • Charleroi, Hainaut, Belgium, 6042
        • Research Site
      • La Louvière, Hainaut, Belgium, 7100
        • Research Site
      • Tournai, Hainaut, Belgium, 7500
        • Research Site
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Research Site
    • Liège
      • Verviers, Liège, Belgium, 4800
        • Research Site
    • Luxembourg
      • Libramont, Luxembourg, Belgium, 6800
        • Research Site
    • West Flanders
      • Sijsele, West Flanders, Belgium, 8340
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) who meet the criteria for prescription of Interferon Beta-1a IM at up to 20 Belgian institutions may participate into this study.

Description

Key Inclusion Criteria:

  • Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization
  • Study enrollment must occur prior to 4th weekly administration of IFN beta-1a
  • Able to understand and complete a self-administered questionnaire
  • No contra-indications for IFN beta-1a

Key Exclusion Criteria:

  • Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component
  • Subjects with primary or secondary progressive MS
  • Subjects with current severe depression and/or suicidal ideation
  • Pregnant women
  • Subjects participating in another clinical trial
  • Subjects who do not want to participate in the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months
Time Frame: Baseline and Month 12
Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.
Baseline and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in EQ-5D VAS at 6, 18 and 24 months
Time Frame: Baseline and Months 6, 18 and 24
Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.
Baseline and Months 6, 18 and 24
Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score
Time Frame: Baseline and Months 6, 12, 18 and 24
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The scores are generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
Baseline and Months 6, 12, 18 and 24
Change from Baseline in EQ-5D Summary Score
Time Frame: Baseline and Months 6, 12, 18 and 24
The EQ-5D is a self-administered questionnaire consisting of 5 questions pertaining to specific health states (i.e., mobility, self-care, pain/discomfort, usual activities and anxiety/depression), with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 is derived from these five dimensions where a score of 1 indicates the best health state.
Baseline and Months 6, 12, 18 and 24
Convenience
Time Frame: Baseline and Months 6, 12, 18 and 24
Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks.
Baseline and Months 6, 12, 18 and 24
Correlation between VAS and MSIS29
Time Frame: Baseline and Months 6, 12, 18 and 24
The correlation between the EQ-5D visual analog scale and Multiple Sclerosis Impact Scale 29 scores will be assessed using the Spearman correlation coefficient.
Baseline and Months 6, 12, 18 and 24
Correlation between VAS and Convenience questionnaire
Time Frame: Baseline and Months 6, 12, 18 and 24
The correlation between the EQ-5D visual analog scale and convenience questionnaire results will be assessed using the Spearman correlation coefficient.
Baseline and Months 6, 12, 18 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-AVO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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