Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
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).