psoriatic arthritis MedDRA version: 17.1 Level: LLT Classification code 10066579 Term: Progression of psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 17.1 Level: LLT Classification code 10066730 Term: Recurrent psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 17.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Mu
Conditions
Interventions
Trade Name: STELARA
Product Name: ustekinumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Psoriatic arthritis according to CASPAR criteria - Active disease defined as: Swollen Joint count =3 and Tender Joint count =3 - Presence of knee and/or ankle arthritis in order to get synovial tissue biopsies 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous use of il-17 blocking therapy or multiple use of tnf-blocking therapies - Contra-indication for needle arthroscopy such as joint replacement and anti-coagulation use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are modulated by IL23/12 P40 blockade. As we have ample evidence that relevant disease-specific pathways are found in the primary target tissues, in particular in synovial tissue obtained from peripheral joints, but not in peripheral blood, we will strongly focus on this compartment by obtaining paired biopsies before and after treatment The primary objective is to assess the effect of IL23/12 P40 blockade on: - the global synovial histology and inflammatory infiltration - the number and type of IL-17 producing cells in PsA synovitis - the production of inflammatory mediators (including IL-17 related cytokines such as IL-22, and pther pro-inflammatory cytokines such as TNF) by total synovial tissue biopsies (ex vivo culture system) as well as by peripheral blood cells - the synovial stromal cell signature - the pan-genomic synovial gene expression profile;Secondary Objective: The secondary objective is to compare which molecular disease pathways are affected by IL23/12 P40 blockade and not by TNF blockade and thereby identify molecular biomarkers which may help to determine which patients may benefit from this treatment in comparison with anti-TNF treatment. ;Primary end point(s): Changes in the synovial cellular and molecular pathways as indicated in the objectives between baseline and week 12;Timepoint(s) of evaluation of this end point: baseline in comparison with week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - stratification of these cellular and molecular changes according to the genetic biomarkers of relevance for anti-IL12/23 treatment - comparison of the synovial/molecular changes induced by anti-Il12/23 treatment response with the changes induced by anti-TNF treatment (i.c.w. samples from a previous performed trial at this center) -correlation between the synovial features at baseline and week 12 ;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Netherlands
Contacts
Public Contactdepartmental secretary and PI
Academic Medical Center
Outcome results
None listed