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Sponsored by: |
University Hospital, Tours |
Information provided by: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT00497614 |
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).
Condition | Intervention |
Rheumatoid Arthritis |
Drug: adalimumab |
MedlinePlus related topics: | Rheumatoid Arthritis |
ChemIDplus related topics: | Adalimumab Fluorodeoxyglucose F18 Tumor Necrosis Factors |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | 18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
France | |||||
University Hospital of Tours | Recruiting | ||||
TOURS, France | |||||
Contact: Denis MULLEMAN 02 47 47 59 17 | |||||
Principal Investigator: Denis MULLEMAN |
University Hospital, Tours |
Principal Investigator: | Denis Mulleman, MD | CHRU de Tours |
Responsible Party: | ( University Hospital Tours ) |
Study ID Numbers: | AOHP05-DM/PETRA |
First Received: | July 4, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00497614 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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