Rheumatoid Arthritis Clinical Trial
Official title:
18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study
Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a
human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha).
Identification of RA patients who respond to biologics is a challenging goal to avoid
unnecessarily, costly and potentially harmful treatment.
The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of
the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR
(American College of Rheumatology) criteria will by enrolled. Patient will receive
adalimumab according to the current guidelines i.e. 40mg /14 days sub cutaneously. The
decision will stand on a high activity of the disease defined by the DAS 28 (Disease
Activity Score) above 5.1. Positron emission tomography will be performed before, 2 and 12
weeks after the begin of the treatment. The response to adalimumab will by assessed by the
SUV (standard Unit value) measured on the inflammatory joints of hands, wrist, ankle, feet
and knees and compared to measurement of clinical (total swollen and tender joints count)
echographic (synovium thickness and power doppler) and chemical biomarkers (erythrocyte
sedimentation rate, C reactive protein).
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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