Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

Rheumatoid Arthritis Clinical Trial

— PETRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497614
• Other study ID #: AOHP05-DM/PETRA
• Status: Completed
• Phase: N/A
• First received: July 4, 2007
• Last updated: December 4, 2008
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• adalimumab

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There is no primary outcome measure specified for this study.			No
Secondary	There are no secondary outcome measures specified for this study.			No