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

This study has been completed.
Information provided by (Responsible Party):
Biogen Identifier:
First received: January 6, 2011
Last updated: October 16, 2015
Last verified: October 2015
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.

Condition Intervention
Multiple Sclerosis
Drug: Interferon beta-1a

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.

Secondary Outcome Measures:
  • Change from Baseline in EQ-5D VAS at 6, 18 and 24 months [ Time Frame: Baseline and Months 6, 18 and 24 ] [ Designated as safety issue: No ]
    Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.

  • Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score [ Time Frame: Baseline and Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in EQ-5D Summary Score [ Time Frame: Baseline and Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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.

  • Convenience [ Time Frame: Baseline and Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks.

  • Correlation between VAS and MSIS29 [ Time Frame: Baseline and Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    The correlation between the EQ-5D visual analog scale and Multiple Sclerosis Impact Scale 29 scores will be assessed using the Spearman correlation coefficient.

  • Correlation between VAS and Convenience questionnaire [ Time Frame: Baseline and Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    The correlation between the EQ-5D visual analog scale and convenience questionnaire results will be assessed using the Spearman correlation coefficient.

Enrollment: 100
Study Start Date: December 2012
Study Completion Date: September 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interferon beta-1a
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01272128

Research Site
Bonheiden, Antwerp, Belgium, 2820
Research Site
Middelheim, Antwerp, Belgium, 2020
Research Site
Ottignies, Brabant Wallon, Belgium, 1340
Research Site
Woluwe, Bruxelles, Belgium, 1200
Research Site
Aalst, East Flanders, Belgium, 9300
Research Site
St Niklaas, East Flanders, Belgium, 9100
Research Site
Tielt, East Flanders, Belgium, 8700
Research Site
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
Hasselt, Limburg, Belgium, 3500
Research Site
Verviers, Liège, Belgium, 4800
Research Site
Libramont, Luxembourg, Belgium, 6800
Research Site
Sijsele, West Flanders, Belgium, 8340
Research Site
Liège, Belgium, 4000
Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT01272128     History of Changes
Other Study ID Numbers: BE-AVO-01 
Study First Received: January 6, 2011
Last Updated: October 16, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on October 21, 2016