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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Biogen Idec.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT01272128

First received: January 6, 2011

Last updated: June 7, 2012

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2011

Last Updated Date

June 7, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01272128 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Convenience [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

A Multicenter, prospective, non-interventional study to evaluate the quality of life in Belgian patients with CIS or RRMS in whom IFN Beta-1a IM has been initiated.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Subjects with RRMS or CIS.

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or Female subjects aged 18 years and over/Decision to treat with IFN beta-1a preceeding enrolment/Study enrolment prior to 4th weekly administration of IFNbeta-1a/Being able to undersrtand and complete sa 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Medical Director

medinfo.belux@biogenidec.com

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01272128

Other Study ID Numbers ^ICMJE

BE-AVO-01

Has Data Monitoring Committee

Responsible Party

Kris Schellens, Biogen Idec Belux

Study Sponsor ^ICMJE

Biogen Idec

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Biogen Idec

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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