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Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
This study has been completed.
First Received: July 4, 2007   Last Updated: December 4, 2008   History of Changes
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

Study Type: Interventional
Study Design: Treatment, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • There is no primary outcome measure specified for this study. [ Time Frame: no ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • There are no secondary outcome measures specified for this study. [ Time Frame: no ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No arm
/
Drug: adalimumab
/

Detailed Description:

/

  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 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.

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

Locations
France
University Hospital of Tours
TOURS, France
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Denis Mulleman, MD CHRU de Tours
  More Information

No publications provided

Responsible Party: / ( University Hospital Tours )
Study ID Numbers: AOHP05-DM/PETRA, /
Study First Received: July 4, 2007
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00497614     History of Changes
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:
Anti-Inflammatory Agents
Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Adalimumab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab
Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 02, 2009