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

NCT ID: NCT01272128

Last Updated: 2015-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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BG9418 Avonex Pen Avonex

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Bonheiden, Antwerp, Belgium

Site Status

Research Site

Middelheim, Antwerp, Belgium

Site Status

Research Site

Ottignies, Brabant Wallon, Belgium

Site Status

Research Site

Woluwe, Brussels Capital, Belgium

Site Status

Research Site

Aalst, East Flanders, Belgium

Site Status

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Saint Niklaas, East Flanders, Belgium

Site Status

Research Site

Tielt, East Flanders, Belgium

Site Status

Research Site

Baudour, Hainaut, Belgium

Site Status

Research Site

Charleroi, Hainaut, Belgium

Site Status

Research Site

Charleroi, Hainaut, Belgium

Site Status

Research Site

La Louvière, Hainaut, Belgium

Site Status

Research Site

Tournai, Hainaut, Belgium

Site Status

Research Site

Hasselt, Limburg, Belgium

Site Status

Research Site

Liège, Liège, Belgium

Site Status

Research Site

Verviers, Liège, Belgium

Site Status

Research Site

Libramont, Luxembourg, Belgium

Site Status

Research Site

Sijsele, West Flanders, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BE-AVO-01

Identifier Type: -

Identifier Source: org_study_id

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