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

Biogen100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1aDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Research Site

Bonheiden, Antwerp, Belgium

Research Site

Middelheim, Antwerp, Belgium

Research Site

Ottignies, Brabant Wallon, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Month 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Months 6, 12, 18 and 24

Data from ClinicalTrials.gov

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