Multiple SclerosisAVAILNCT01272128
Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study
An observational study of Multiple Sclerosis, run by Biogen at 17 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1a
- How many people
- 100 participants
- Where
- 17 sitesBelgium
- Study dates
- Dec 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Belgium17 sites
Research Site
Aalst, East Flanders, 9300
Research Site
Baudour, Hainaut, 7331
Research Site
Bonheiden, Antwerp, 2820
Research Site
Charleroi, Hainaut, 6000
Research Site
Charleroi, Hainaut, 6042
Research Site
Hasselt, Limburg, 3500
Research Site
La Louvière, Hainaut, 7100
Research Site
Libramont, Luxembourg, 6800
Research Site
Liège, Liège, 4000
Research Site
Middelheim, Antwerp, 2020
Research Site
Ottignies, Brabant Wallon, 1340
Research Site
Saint Niklaas, East Flanders, 9100
Research Site
Sijsele, West Flanders, 8340
Research Site
Tielt, East Flanders, 8700
Research Site
Tournai, Hainaut, 7500
Research Site
Verviers, Liège, 4800
Research Site
Woluwe, Brussels Capital, 1200
About this 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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1aDrug
Also called BG9418, Avonex Pen, Avonex
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 12
Secondary outcomes (6)
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.
Measured: Baseline and Months 6, 18 and 24
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.
Measured: Baseline and Months 6, 12, 18 and 24
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.
Measured: Baseline and Months 6, 12, 18 and 24
Convenience
Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks.
Measured: Baseline and Months 6, 12, 18 and 24
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.
Measured: Baseline and Months 6, 12, 18 and 24
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.
Measured: Baseline and Months 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272128
- Sponsor's protocol ID
- BE-AVO-01
- Acronym
- AVAIL
- Status last verified
- Oct 2015
- First submitted
- 6 Jan 2011
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01272128
- Acronym / sponsor ID
- AVAIL / BE-AVO-01
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1aAlso: BG9418, Avonex Pen, AvonexInterferon 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. | Drug | – |
Primary outcome
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.
6 secondary outcomes
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 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 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 MSIS29
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 17 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.