Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study (AVAIL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01272128|
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Interferon beta-1a|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2015|
Drug: Interferon beta-1a
- Avonex Pen
- Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months [ Time Frame: 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.
- Change from Baseline in EQ-5D VAS at 6, 18 and 24 months [ Time Frame: 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.
- Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score [ Time Frame: 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.
- Change from Baseline in EQ-5D Summary Score [ Time Frame: 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.
- Convenience [ Time Frame: 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 MSIS29 [ Time Frame: 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.
- Correlation between VAS and Convenience questionnaire [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272128
|Bonheiden, Antwerp, Belgium, 2820|
|Middelheim, Antwerp, Belgium, 2020|
|Ottignies, Brabant Wallon, Belgium, 1340|
|Woluwe, Bruxelles, Belgium, 1200|
|Aalst, East Flanders, Belgium, 9300|
|St Niklaas, East Flanders, Belgium, 9100|
|Tielt, East Flanders, Belgium, 8700|
|Baudour, Hainaut, Belgium, 7331|
|Charleroi, Hainaut, Belgium, 6000|
|Charleroi, Hainaut, Belgium, 6042|
|La Louvière, Hainaut, Belgium, 7100|
|Tournai, Hainaut, Belgium, 7500|
|Hasselt, Limburg, Belgium, 3500|
|Verviers, Liège, Belgium, 4800|
|Libramont, Luxembourg, Belgium, 6800|
|Sijsele, West Flanders, Belgium, 8340|
|Liège, Belgium, 4000|
|Study Director:||Medical Director||Biogen|