Immunogenicity and Safety of Subcutaneously-Administered Avonex (Interferon Beta 1-a) in Multiple Sclerosis (MS) Subjects
This study has been terminated.
Information provided by:
First received: October 29, 2008
Last updated: January 16, 2009
Last verified: January 2009
This study is being conducted to determine the immunogenicity and safety of Avonex (Interferon Beta 1-a) 30 mcg when administered subcutaneously (SC) once weekly to interferon-naive subjects.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex (Interferon Beta-1a) 30 Mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Clinical Laboratory Values, Antibodies & Adverse Events [ Time Frame: All Visits - Approx. every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Each subject enrolled in this study will administer 30 mcg of Avonex Subcutaneously once a week, for 18 months.
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
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