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

This study has been completed.
Information provided by:
Biogen Identifier:
First received: June 25, 2007
Last updated: June 15, 2009
Last verified: June 2009
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.

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:

Further study details as provided by Biogen:

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
multi-center using 150-200 neurologists and their patient populations.

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
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 identifier: NCT00492570

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

Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00492570     History of Changes
Other Study ID Numbers: GER-009-06-AVX
Study First Received: June 25, 2007
Last Updated: June 15, 2009

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

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017