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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:  EUCTR2010-021435-14-NL
Date of registration: 24/06/2010
Prospective Registration: Yes
Primary sponsor: Academisch Medisch Centrum Amsterdam
Public title: Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis
Scientific title: Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis
Date of first enrolment: 06/12/2010
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Countries of recruitment
Key inclusion & exclusion criteria
Inclusion criteria:
Males and females with a diagnosis of active rheumatoid arthritis (with a DAS28 CRP > 3,2) who have failed MTX therapy, with an inflamed knee, ankle or wrist joint.
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:
Subjects who are impaired, incapacitated, or incapable of completing study
related assessments.
Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
Subjects who have previously received treatment with an investigational biologic RA therapy, anti-TNF therapy, rituximab, tocilizumab or abatacept.

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection

Primary Outcome(s)
Main Objective: The primary objective is to study changes in synovial inflammation in serial biopsy samples following administration of abatacept therapy to subjects with active rheumatoid arthritis.
Primary end point(s): the change of the cell infiltrate and the expression of cytokines in the synovial tissue after treatment with abatacept
Secondary Objective: The secondary objectives of this study are to (I) assess clinical response (II) assess cellular responses of synovial explants to inflammatory stimuli, and/or antagonists (III) identify synovial biomarkers predictive of the clinical response to abatacept treatment (IV) investigate the changes in phenotypes of peripheral blood mononuclear cells (PBMCs)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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