Clinical trial NCT01272128: Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) who meet the criteria for prescription of Interferon Beta-1a IM at up to 20 Belgian institutions may participate into this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change from Baseline in EQ-5D VAS at 6, 18 and 24 months
timeFrame: Baseline and Months 6, 18 and 24
measure: Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score
timeFrame: Baseline and Months 6, 12, 18 and 24
measure: Change from Baseline in EQ-5D Summary Score
timeFrame: Baseline and Months 6, 12, 18 and 24
measure: Convenience
timeFrame: Baseline and Months 6, 12, 18 and 24
measure: Correlation between VAS and MSIS29
timeFrame: Baseline and Months 6, 12, 18 and 24
measure: Correlation between VAS and Convenience questionnaire
timeFrame: Baseline and Months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Research Site
state: Antwerp
city: Middelheim
country: Belgium
facility: Research Site
state: Antwerp
city: Ottignies
country: Belgium
facility: Research Site
state: Brabant Wallon
city: Woluwe
country: Belgium
facility: Research Site
state: Bruxelles
city: Aalst
country: Belgium
facility: Research Site
state: East Flanders
city: St Niklaas
country: Belgium
facility: Research Site
state: East Flanders
city: Tielt
country: Belgium
facility: Research Site
state: East Flanders
city: Baudour
country: Belgium
facility: Research Site
state: Hainaut
city: Charleroi
country: Belgium
facility: Research Site
state: Hainaut
city: Charleroi
country: Belgium
facility: Research Site
state: Hainaut
city: La Louvière
country: Belgium
facility: Research Site
state: Hainaut
city: Tournai
country: Belgium
facility: Research Site
state: Hainaut
city: Hasselt
country: Belgium
facility: Research Site
state: Limburg
city: Verviers
country: Belgium
facility: Research Site
state: Liège
city: Libramont
country: Belgium
facility: Research Site
state: Luxembourg
city: Sijsele
country: Belgium
facility: Research Site
state: West Flanders
city: Liège
country: Belgium
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: