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

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Device: HR-pQCT

• Registration Number: NCT02526992
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Last Update Submitted: 2015-08-17
• Study First Posted: 2015-08-18
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with anti-TNF therapy	HR-pQCT	patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy

Primary Outcome Measures

Name	Time	Method
trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT	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®).

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France