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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492570
First Posted: June 27, 2007
Last Update Posted: June 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  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:


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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
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
Biogen
Investigators
Principal Investigator: Biogen-Idec Study Director Biogen
  More Information

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00492570     History of Changes
Other Study ID Numbers: GER-009-06-AVX
First Submitted: June 25, 2007
First Posted: June 27, 2007
Last Update Posted: June 16, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Sclerosis
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