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GER-009-06-AVX Early Therapy in Multiple Sclerosis (FIT)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00492570
First received: June 25, 2007
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

This study is being done to increase awareness for early therapy with Avonex for Multiple Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data for Avonex.


Condition
Relapsing-Remitting Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GER-009-06-AVX Early Therapy in Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Enrollment: 230
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This study will address the cognitive dysfunction associated with MS. It will track these changes and show that early intervention with Avonex is effective in slowing MS and its effect on patients. Safety data will also be collected during this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

multi-center using 150-200 neurologists and their patient populations.

Criteria

Inclusion Criteria:

  • CIS (according to indication) or early Relapsing Remitting Multiple Sclerosis

Exclusion Criteria:

  • treatment with DMT during the last 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492570

Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Study Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00492570     History of Changes
Other Study ID Numbers: GER-009-06-AVX
Study First Received: June 25, 2007
Last Updated: June 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biogen Idec:
Multiple Sclerosis
Cognitive Dysfunction in Multiple sclerosis
early treatment
 Avonex
interferon beta 1a
Cognitive Dysfunction

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 May 22, 2013