Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA) (PETRA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Positron emission tomodensitometry, Tumor necrosis factor alpha inhibitor
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.
Sites / Locations
- University Hospital of Tours
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
No arm
Arm Description
Outcomes
Primary Outcome Measures
There is no primary outcome measure specified for this study.
Secondary Outcome Measures
There are no secondary outcome measures specified for this study.
Full Information
NCT ID
NCT00497614
First Posted
July 4, 2007
Last Updated
December 4, 2008
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT00497614
Brief Title
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
Acronym
PETRA
Official Title
18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Positron emission tomodensitometry, Tumor necrosis factor alpha inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No arm
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
adalimumab
Primary Outcome Measure Information:
Title
There is no primary outcome measure specified for this study.
Secondary Outcome Measure Information:
Title
There are no secondary outcome measures specified for this study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Mulleman, MD
Organizational Affiliation
CHRU de Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
Country
France
12. IPD Sharing Statement
Learn more about this trial
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
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