An observational study in Arthritis, Psoriatic, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-21.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
The purpose of this study is to determine the mechanism of action on target tissue level of ustekinumab treatment in psoriatic arthritis patients.
Patients who are planning to start treatment with anti-p40 therapy (ustekinumab) will be included in the trial.
At week 0, 12 and 24 peripheral blood, synovial tissue and skin will be obtained and analysed with different techniques to assess the effect of the therapy on inflammatory pathways.
Rationale:
The overall aim of the study is to determine which downstream cellular and molecular pathways involved in psoriatic arthritis (PsA) pathogenesis are modulated by Interleukine 23/Interleukine12 P40 subunit (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.
Objectives:
The primary objective is to assess the effect of IL23/12 P40 blockade on cellular en molecular pathways involved in PsA disease in the synovium, in the synovial fluid and peripheral blood.
The secondary objective is to compare which cellular/molecular disease pathways are affected by IL23/12 P40 blockade and not by tumour necrosis factor (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.
Study design:
Single centre, 24-week open-label study in subjects with clinically active peripheral psoriatic arthritis receiving treatment with ustekinumab.
Synovial biopsies will be obtained from patients before and after 12 and 24 weeks of treatment with ustekinumab.
Study population:
Patients with a diagnosis of psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with at least one swollen knee or ankle joint who are planning to receive treatment with ustekinumab at the outpatient clinic. In total 16 patients will be included.
Intervention: Blood withdrawal and mini-arthroscopies at different timepoints.
Main study parameters/endpoints:
Primary study parameters/outcome of the study:
Secondary study parameters/outcome of the study:
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 16 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Patients with a diagnosis of psoriatic arthritis according to the CASPAR criteria with at least one swollen knee or ankle joint who are planning to receive treatment with ustekinumab at the outpatient clinic. In total 16 patients will be included.
Exclusion Criteria:
Patients with a diagnosis of psoriatic arthritis according to the CASPAR criteria with at least one swollen knee or ankle joint who are planning to receive treatment with ustekinumab at the outpatient clinic. An arthroscopy will be done in the swollen knee/ankle at week 0, 12 and 24.
Procedure: Arthroscopy
Arthroscopy of swollen joint (ankle/knee)
Biological effect of treatment on synovium obtained via arthroscopy from a swollen knee or ankle.
Cellular and molecular changes of the synovium.
Time frame: Cellular and molecular changes of the synovium of samples obtained at week 0 compared with week 12 and week 24.
biological effect of anti TNF v.s. anti IL23/IL12 p40 on synovium obtained from a swollen knee or ankle.
molecular and cellular changes affected by anti IL23/IL12 p40 and not by anit TNF therapy.
Time frame: week 0 compared with week 12 and week 24
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)