Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006256-22-FR

Enrollment

Registered

2008-10-31

Start date

2008-11-21

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions

Interventions

Trade Name: remicade Pharmaceutical Form: Intravenous infusion INN or Proposed INN: infliximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men from 18 to 65 years old - Women from 18 years old to menopause - Patient with a polyarthritis rhumatoïd ( diagnostic criteria of the ACR) badly controlled by the usual treatments(DAS28>3) - Patient affiliated or beneficiary of a national insurance system - Patient with signed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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
Main Objective: Describe the modifications of the trabecular volume of the lower extremity of the radius in zone under chondrale at patients affected by rheumatoid polyarthritis Insufficiently controlled by a conventional treatment, in the first 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab);Secondary Objective: Describe the modifications of the trabecular and cortical microarchitecture of the lower extremity of the radius in zone under chondrale at patients affected by rheumatoid polyarthritis Insufficiently controlled by a conventional treatment, in the first 6 and 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab) Describe the modifications of the remote osseous microarchitecture of a joint at the level of the shin in the first 6 and 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab) ;Primary end point(s): Trabecular volume (bone volume/tissu volume) %	—

Measure

Time frame

Main Objective: Describe the modifications of the trabecular volume of the lower extremity of the radius in zone under chondrale at patients affected by rheumatoid polyarthritis Insufficiently controlled by a conventional treatment, in the first 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab);Secondary Objective: Describe the modifications of the trabecular and cortical microarchitecture of the lower extremity of the radius in zone under chondrale at patients affected by rheumatoid polyarthritis Insufficiently controlled by a conventional treatment, in the first 6 and 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab) Describe the modifications of the remote osseous microarchitecture of a joint at the level of the shin in the first 6 and 12 months following the institution of a treatment by anti-TNF (infliximab, etanercept, adalimumab) ;Primary end point(s): Trabecular volume (bone volume/tissu volume) %

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026