Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

• Conditions: rheumatoid arthritis

• Registration Number: EUCTR2010-021435-14-NL
• Lead Sponsor: Academisch Medisch Centrum Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Pregnancy
Breastfeeding
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
erythematous).
Subjects who have previously received treatment with an investigational biologic RA therapy, anti-TNF therapy, rituximab, tocilizumab or abatacept.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): the change of the cell infiltrate and the expression of cytokines in the synovial tissue after treatment with abatacept;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.;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)