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
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Avonex-evaluation of Quality of Life and Convenience in Belgian Patients - The AVAIL Study

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Convenience [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with RRMS or CIS.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272128

Contacts
Contact: Medical Director medinfo.belux@biogenidec.com

Locations
Belgium
Research Site Recruiting
Antwerpen, Belgium
Research Site Recruiting
Brabant Wallon, Belgium
Research Site Recruiting
Bruxelles, Belgium
Research Site Recruiting
Hainaut, Belgium
Research Site Recruiting
Limburg, Belgium
Research Site Recruiting
Liège, Belgium
Research Site Recruiting
Luxembourg, Belgium
Research Site Recruiting
Oost-Vlaanderen, Belgium
Research Site Recruiting
West-Vlaanderen, Belgium
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Kris Schellens, Biogen Idec Belux
ClinicalTrials.gov Identifier: NCT01272128     History of Changes
Other Study ID Numbers: BE-AVO-01
Study First Received: January 6, 2011
Last Updated: June 7, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014