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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02526992
• Other study ID #: 0701104
• Secondary ID: 2008-006256-22A8
• Status: Terminated
• Phase: N/A
• First received: August 17, 2015
• Last updated: August 17, 2015
• Start date: May 2009
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT	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	No