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

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ClinicalTrials.gov Identifier: NCT00492570
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : June 16, 2009
Information provided by:

Brief Summary:
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 or disease
Relapsing-Remitting Multiple Sclerosis

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.

Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GER-009-06-AVX Early Therapy in Multiple Sclerosis
Study Start Date : April 2006
Primary Completion Date : October 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492570

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

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00492570     History of Changes
Other Study ID Numbers: GER-009-06-AVX
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 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