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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT01272128
• Date of registration: 06/01/2011
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study AVAIL
• Scientific 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
• Date of first enrolment: December 2012
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01272128
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Belgium, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1a

Primary Outcome(s)

Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months [Time Frame: Baseline and Month 12]

Secondary Outcome(s)

Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score [Time Frame: Baseline and Months 6, 12, 18 and 24]

Change from Baseline in EQ-5D VAS at 6, 18 and 24 months [Time Frame: Baseline and Months 6, 18 and 24]

Change from Baseline in EQ-5D Summary Score [Time Frame: Baseline and Months 6, 12, 18 and 24]

Convenience [Time Frame: Baseline and Months 6, 12, 18 and 24]

Correlation between VAS and Convenience questionnaire [Time Frame: Baseline and Months 6, 12, 18 and 24]

Correlation between VAS and MSIS29 [Time Frame: Baseline and Months 6, 12, 18 and 24]

Secondary ID(s)

BE-AVO-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors