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

Multiple Sclerosis Clinical Trial

— AVAIL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272128
• Other study ID #: BE-AVO-01
• Status: Completed
• Phase: N/A
• First received: January 6, 2011
• Last updated: October 16, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Research Site	Aalst	East Flanders
Belgium	Research Site	Baudour	Hainaut
Belgium	Research Site	Bonheiden	Antwerp
Belgium	Research Site	Charleroi	Hainaut
Belgium	Research Site	Charleroi	Hainaut
Belgium	Research Site	Hasselt	Limburg
Belgium	Research Site	La Louvière	Hainaut
Belgium	Research Site	Libramont	Luxembourg
Belgium	Research Site	Liège
Belgium	Research Site	Middelheim	Antwerp
Belgium	Research Site	Ottignies	Brabant Wallon
Belgium	Research Site	Sijsele	West Flanders
Belgium	Research Site	St Niklaas	East Flanders
Belgium	Research Site	Tielt	East Flanders
Belgium	Research Site	Tournai	Hainaut
Belgium	Research Site	Verviers	Liège
Belgium	Research Site	Woluwe	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No