Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
NCT ID: NCT00497614
Last Updated: 2008-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No arm
adalimumab
Interventions
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adalimumab
Eligibility Criteria
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Inclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Principal Investigators
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Denis Mulleman, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU de Tours
Locations
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University Hospital of Tours
Tours, , France
Countries
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Other Identifiers
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AOHP05-DM/PETRA
Identifier Type: -
Identifier Source: org_study_id
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