|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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
/
|
/
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
| 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 |
|
Rheumatoid arthritis Positron emission tomodensitometry Tumor necrosis factor alpha inhibitor |
|
Anti-Inflammatory Agents Necrosis Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Antirheumatic Agents Adalimumab |
|
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 |