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Clinical Trials/NCT00497614
NCT00497614
Completed
Not Applicable

18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study

University Hospital, Tours1 site in 1 country8 target enrollmentMay 2006
Interventionsadalimumab

Overview

Phase
Not Applicable
Intervention
adalimumab
Conditions
Rheumatoid Arthritis
Sponsor
University Hospital, Tours
Enrollment
8
Locations
1
Primary Endpoint
There is no primary outcome measure specified for this study.
Status
Completed
Last Updated
17 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with active Rheumatoid arthritis PR définie selon les critères ACR (1987) (annexe 7) \[18\], Activité importante de la maladie (DAS 28 \> 5,1) (annexe 5) \[7\], Indication d'un traitement par adalimumab (en accord avec l'A.M.M.), Homme ou femme dont l'âge est supérieur ou égal à 18 ans, Acceptant de participer à l'étude et ayant donné son consentement éclairé, Affiliés ou bénéficiaire d'un régime de sécurité sociale.

Exclusion Criteria

  • Not provided

Arms & Interventions

No arm

Intervention: adalimumab

Outcomes

Primary Outcomes

There is no primary outcome measure specified for this study.

Secondary Outcomes

  • There are no secondary outcome measures specified for this study.

Study Sites (1)

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