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Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

This study is currently recruiting participants.
Verified by University Hospital, Tours, July 2008

Sponsored by: University Hospital, Tours
Information provided by: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00497614
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by University Hospital, Tours:

Estimated Enrollment:   8
Study Start Date:   May 2006

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with active Rheumatoid arthritis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497614

Locations
France
University Hospital of Tours     Recruiting
      TOURS, France
      Contact: Denis MULLEMAN     02 47 47 59 17        
      Principal Investigator: Denis MULLEMAN            

Sponsors and Collaborators
University Hospital, Tours

Investigators
Principal Investigator:     Denis Mulleman, MD     CHRU de Tours    
  More Information


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

Keywords provided by University Hospital, Tours:
Rheumatoid arthritis  
Positron emission tomodensitometry  
Tumor necrosis factor alpha inhibitor  

Study placed in the following topic categories:
Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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