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

NCT ID: NCT02526992

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-04-30

Brief Summary

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®).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

HR-pQCT

Intervention Type: DEVICE

HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at radius levels in humans.

Interventions

HR-pQCT

HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at radius levels in humans.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry THOMAS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2008-006256-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A81070-40

Identifier Type: OTHER

Identifier Source: secondary_id

0701104

Identifier Type: -

Identifier Source: org_study_id