Psoriatic Arthritis
Conditions
Interventions
Trade Name: Orencia
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of t
Sponsors
St. Vincents University Hospital, Department of Rheumatology.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must give written informed consent, given prior to any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care. Patients between the ages 18 and 80 years, with a joint disease onset after 16 years old Patients with active PsA (CASPAR criteria) of > 3 months duration defined by the following criteria: Active arthritis with >3 swollen joints and >3 tender joints considered capable of responding to drug therapy. Should present a clinical synovitis of a knee and have accepted to undergo synovial biopsies ? At least one of the inflamed joints should be a knee joint.§ An evaluable psoriatic skin lesion, diagnosed by a consultant rheumatologist or a dermatologist is not a pre-requisite but where possible such patients will be recruited . 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: ·WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to14 weeks after the last dose of tre·atment Female patients who are pregnant or breast-feeding. ·Subjects who meet diagnostic criteria for any other rheumatic disease Subjects who are impaired, incapacitated, or incapable of completing study related assessments (including prisoners and patients detained for treatment of psychiatric illness)· Evidence of skin conditions other than psoriasis .· History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).· Subjects with current clinical or laboratory evidence of active tuberculosis .· Latent TB which was not successfully treated.·Active severe infection · Have history of drug (including narcotics) abuse, or current active problems with drug or alcohol abuse· Subjects who have received a previous systemic treatment with biologic DMARDs, including cytokines/anti-cytokines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the change in immunohistochemical markers of synovial inflammation from baseline to 6 months, in patients with active PsA (CASPAR criteria) of > 3 months duration. ;Secondary Objective: The secondary objectives of this study are to assess: 1.MRI changes over time in PsA patients on Abatacept. 2.Articular and skin clinical outcomes over time in patients with PsA on Abatacept. 3.Skin immunohistologic change, in particular change in T-reg expression comparison between baseline, 1 and 6 months in patients on Abatacept. To assess the safety and tolerability of Abatacept in this study population, evaluated by number of adverse events related to drug therapy. ;Primary end point(s): Response to treatment will be measured by the change in immunohistochemical markers of synovial inflammation from baseline to 6 months in patients with active PsA (CASPAR criteria) of > 3 months duration. Using a standard mini-arthroscopic procedure, synovial tissue will be obtained from an inflamed knee joint at 0, 1 and 6 months. Tissue will be embedded in OCT for standard immunohistochemical staining to include cell surface markers (CD3, CD4, CD8, CD68), intracellular T Reg marker FoxP3 and markers of vascularity (Factor VIII). Additional stains for T cell activation markers (CD28) can also added. Staining will be quantified by digital image analysis as outlined below and compared at each time point. All of the synovial immunohistologic analysis will be performed at the end of the study Digital image analysis Eighteen high power images will be taken per slide for each of the cell specific markers stained. In the case of CD68, the intimal lining layer will be highlighted manually per image, such that staining can be quantified in 2 areas - the intimal lining (LL) and synovial sublining (SL) layers. Analysis will be performed using the Qwin analysis system (Leica, Cambridge, UK). Results will be expressed as the number of | — |
Countries
Ireland
Contacts
Public ContactOliver FitzGerald
St Vincents University Hospital
Outcome results
None listed