Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
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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: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study |
- There is no primary outcome measure specified for this study. [ Designated as safety issue: No ]
- There are no secondary outcome measures specified for this study. [ 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
/
Other Name: /
|
Detailed Description:
/
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
More Information
No publications provided
| Responsible Party: | University Hospital Tours, / |
| ClinicalTrials.gov Identifier: | NCT00497614 History of Changes |
| Other Study ID Numbers: | AOHP05-DM/PETRA, / |
| Study First Received: | July 4, 2007 |
| Last Updated: | December 4, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Tours:
|
Rheumatoid arthritis Positron emission tomodensitometry Tumor necrosis factor alpha inhibitor |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013