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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01272128
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Study Start: 2012-12
• Primary Completion: 2014-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months	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 Outcome Measures

Name	Time	Method
Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score	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.
Correlation between VAS and MSIS29	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.
Change from Baseline in EQ-5D Summary Score	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.
Change from Baseline in EQ-5D VAS at 6, 18 and 24 months	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.
Convenience	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.
Correlation between VAS and Convenience questionnaire	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.

Trial Locations

Locations (1)

Research Site; 🇧🇪 Liège, Belgium