rheumatoid arthritis
Conditions
Interventions
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
Sponsors
Academisch Medisch Centrum Amsterdam
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Netherlands
Outcome results
None listed