Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497614
Status:
COMPLETED
Last Update Posted:
2008-12-05
First Post:
2007-07-04
Brief Title:
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab PETRA
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis A Monocentric Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PETRA
Brief 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 ie 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 51 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
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 ie 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 51 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None