World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-006256-22-FR
Date of registration: 31/10/2008
Prospective Registration: Yes
Primary sponsor: CHU Saint-Etienne
Public title: Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.
Scientific title: Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.
Date of first enrolment: 21/11/2008
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006256-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
France
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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:
- Concomitant osseous disease (Paget's disease, osteomalacia...)
- Endocrinopathy defined on biological criteria (Cushing's disease, hyperthyroidism, hypogonadism...)
- Patients under protection of justice
- Refusal consent


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions
Intervention(s)

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-

Trade Name: humira
Pharmaceutical Form: Injection*
INN or Proposed INN: adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: enbrel
Pharmaceutical Form: Injection*
INN or Proposed INN: etanercept
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)
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)
Primary end point(s): Trabecular volume (bone volume/tissu volume) %
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)
Secondary Outcome(s)
Secondary ID(s)
0701104
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history