Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

NCT00497614 | Completed

• 1 other identifier: AOHP05-DM/PETRA
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Positron emission tomodensitometry; Tumor necrosis factor alpha inhibitor

Outcome Measures

Primary Outcomes (1)

• There is no primary outcome measure specified for this study.

Secondary Outcomes (1)

• There are no secondary outcome measures specified for this study.

Study Arms (1)

No arm

OTHER

Drug: adalimumab

Interventions

adalimumab DRUG

No arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Denis Mulleman, MD

  CHRU de Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 5, 2008

Record last verified: 2008-12

Locations

FR (1)