DCE-MRI Study (Dynamic Contrast-Enhanced Magnetic Resonance Imaging)
The purpose of this study is to assess whether DCE-MRI can detect changes of active disease in RA subjects after 4, 8 and 12 weeks of etanercept.
Amgen has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept|
|Study Start Date:||September 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
The current literature shows the promise of MRI for assessing response to therapy in RA but the heterogeneity of the methodology and the semi-quantitative nature of the image analysis limits its applicability. To evaluate the ability of DCE-MRI to serve as a biomarker for treatment-induced changes in RA associated synovial inflammation, the reproducibility of the measurement and an effect size are required. Additional endpoints such as synovial volume, bone erosion progression and bone marrow edema-like changes may also prove useful for short-term assessment of a therapeutic intervention, but have not been explored in the context of a pharmacodynamic biomarker. It is therefore critical to conduct a carefully designed longitudinal study, focused on identifying the key parameters related to the instrumentation and data analysis, to fully evaluate the potential utility of MRI in an early clinical development setting. Importantly, this study will also demonstrate the feasibility of using DCE-MRI at multiple centers to acquire useful information that will drive program decisions.
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
|United States, California|
|Los Angeles, California, United States|
|United States, Washington|
|Seattle, Washington, United States|
|London, United Kingdom|