Rheumatoid Arthritis Clinical Trial
Official title:
DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept
The purpose of this study is to assess whether DCE-MRI can detect changes of active disease in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.
The current literature shows the promise of magnetic resonance imaging (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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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