Objective: We want to extend our understanding of the disease aetiology by performing a small pilot study that incorporates other immunologic sites involved in the disease (the skin and the microbiome) while additionally strengthening our disease…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Integrative systems medicine profile will be derived from blood samples (RNA
sequencing, micro RNA profiling, genome-wide methylation, flow-cytometry; same
as in protocol 13-696), skin biopsies (immunohistochemistry and single cell
sequencing), and microbiome (skin/gut 16S rRNA sequencing).
-Established disease activity parameters will be assessed (e.g. joint count,
enthesitis count, CRP) along with novel disease activity parameters aimed at
detecting early (sub-clinical) changes in the joint/enthesis (i.e. MRI of the
feet; whole body FDG-PET/CT).
Group differences with respect to systems medicine profile and novel
radiographic imaging will be compared between Pso and PsA (with AS serving as
disease control group). The relationship between the early changes in the
joint/enthesis (as detected with novel imaging) will be compared to the
underlying molecular pathways (as detected by integrative systems medicine
profile).
Secondary outcome
The prospective value of integrative systems medicine profile and (novel)
disease activity parameters on disease course and response to treatment will be
evaluated.
Novel imaging techniques (MRI of the feet; whole body FDG-PET/CT) will be
compared to established disease activity parameters to evaluate their
complementary/additional use as disease-activity parameters.
Background summary
Rationale: Patients with psoriatic arthritis have a reduced quality of life and
would greatly benefit from the identification of novel diagnostic markers
capable of detecting early stages of disease and the identification of novel
therapeutic targets. Protocol 13-696 is currently investigating the molecular
pathways driving the development of psoriatic arthritis in a large cohort of
patients. Protocol 13-696 is using the systems medicine approach to identify
novel therapeutic and diagnostic markers derived from blood samples in study
participants.
Study objective
Objective: We want to extend our understanding of the disease aetiology by
performing a small pilot study that incorporates other immunologic sites
involved in the disease (the skin and the microbiome) while additionally
strengthening our disease outcome measures (by including novel imaging
techniques that can detect early stages of the disease).
The primary objectives are
1) To identify novel diagnostic targets aimed at differentiating psoriasis
limited to the skin from psoriatic arthritis
2) To identify novel therapeutic targets aimed at joint and enthesis
inflammation in (early) psoriatic arthritis
The secondary objectives are
3) To identify prognostic markers of disease course and response to treatment
4) To identify severity-of-disease markers that reflect the disease
activity/severity
Study design
Study design: Observational, longitudinal study for a maximum duration of two
years being conducted in the outpatient clinic of the dermatology and
rheumatology departments.
Study burden and risks
Per participant the following study interventions will be performed :
-three times vena puncture (80mL drawn each time): negligible risk
-one time 4 skin biopsies (4mm): low risk
-one time microbiome samples collected (faeces sample and skin swab):
negligible risk
-one time FDG-PET(CT) whole body: low risk
-three times MRI-feet with gadolinium contrast: low risk
-three times questionnaires: negligible risk
-in psoriasis patients specifically, three times clinical evaluation including
X-rays of hands and feet which are not part of standard care: negligible risk
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Cohort Pso: N<=25 patients with psoriasis
* Cohort PsA: N<=25 patients with psoriatic arthritis
* Cohort AS: N<=25 patients with ankylosing spondylitis;age 18-55
Exclusion criteria
Use of immunomodulatory drugs
Contraindications to FDG-PET/CT, MRI scanner
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53860.041.15 |