Evaluation by HR-pQCT of Bone Microarchitecture Changes in Patients With Rheumatoid Arthritis Under Anti-TNF Therapy.

August 17, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and is characterized by chronic inflammation of the joints leading to their destruction, resulting in a major loss of function.

The investigators propose a pilot study for studying changes in bone microarchitecture with High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural parameters in subchondral area near an inflammatory joint during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-etienne, France, 42000
        • CHU DE SAINT-ETIENNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men from 18 to 65 years old
  • Women from 18 years old to menopause
  • Patient with a polyarthritis rheumatoid no controlled by the usual treatment (DAS28>3)
  • Patient affiliated or beneficiary of a national insurance system
  • Patient with signed consent

Exclusion Criteria:

  • Concomitant osseous disease (Paget's disease, osteomalacia...)
  • Endocrinopathy defined on biological criteria (Cushing's disease, hyperthyroidism, hypogonadism...)
  • Patients under protection of justice
  • Refusal consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients with anti-TNF therapy
patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy
Device: HR-pQCT
HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at radius levels in humans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT
Time Frame: 12 months after intitiation of anti-TNF treatment
Describe changes to trabecular volume of the distal radius in subchondral area in patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).
12 months after intitiation of anti-TNF treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thierry THOMAS, MD PhD, CHU DE SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701104
  • 2008-006256-22 (EudraCT Number)
  • A81070-40 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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