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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1a


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months | 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 | 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 | 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 | 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 | 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 | 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 | 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 |