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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02526992

Enrollment

Registered

2015-08-18

Start date

2009-05-31

Completion date

2015-04-30

Last updated

2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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®).

Interventions

DEVICEHR-pQCT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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®).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026