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Completed

NCT Number: NCT01272128

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bonheiden, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Interferon beta-1a

Drug

Interferon beta-1a will not be provided as a part of this study. Participants will receive Interferon beta-1a as prescribed by their treating physician prior to enrollment.

Other names: BG9418, Avonex Pen, Avonex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: AVAIL

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 7, 2011
Registry last updated
Oct 20, 2015

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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