The primary objective is to identify molecular signatures that can serve as diagnostic and/or severity-of-disease markers for PsA and markers that can predict treatment response in patients with PsA. The secondary objective is to elucidate theā¦
ID
Source
Brief title
Condition
- Autoimmune disorders
- Synovial and bursal disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical endpoints: Diagnosis (conform CASPAR criteria), disease activity and
treatment response (conform the composite scores DAS28, ACR, and CPDAI). For
details see section 8.1.1. of the study protocol.
Laboratory endpoints: the transcriptome (RNA sequencing), the epigenome (micro
RNA profiling and genome-wide methylation) and the proteome in white blood
cells derived from the blood samples collected throughout follow-up. The
frequency, phenotype, and function of the white blood cells will be
quantified. For details see section 8.2.1. and 8.4.7 of the study protocol.
Secondary outcome
n.a.
Background summary
Psoriatic arthritis (PsA) is currently underdiagnosed and often resistant to
treatment with traditional anti-rheumatic drugs, leading to increased morbidity
and mortality. The pathogenesis of PsA is not fully understood but thought to
arise from the combination of genetic, epigenetic, and environmental factors.
The so-called *systems biology approach* uses high through-put technologies to
help unravel the complex interactions between such factors in order to better
understand the specific pathways leading to a state of disease.
Study objective
The primary objective is to identify molecular signatures that can serve as
diagnostic and/or severity-of-disease markers for PsA and markers that can
predict treatment response in patients with PsA. The secondary objective is to
elucidate the underlying pathways in the development of PsA with the aim of
uncovering novel therapeutic targets.
Study design
Longitudinal observational study, where blood samples and clinical parameters
will be prospectively collected for a maximum duration of five years per
patient, and the data will be analysed using the systems biology approach.
Study burden and risks
The burden of participation relies mainly on extra blood draws and filling in
the questionnaires. Apart from possible small side effects of additional blood
being drawn (small hematoma), no risks are involved.
Study participants with a diagnosis of psoriasis (population 1) will be
clinically evaluated by a rheumatologist at baseline for the presence of PsA
and will be asked to perform one blood sample at baseline (80 mL blood volume),
and be asked to perform PsA-screening questionnaires once per year during
follow-up.
Study participants with a diagnosis of PsA (population 2 & 3) will be asked to
undergo a minimum of one blood sample per year and maximum of three blood
samples per year (80 mL blood volume each time). This blood draw will coincide
with a blood draw that is necessary for clinical purposes and will be randomly
selected. Participants will receive questionnaires at the same time points of
the blood draw.
Study participants with a diagnosis of non-PsA spondyloarthritis (population 4)
will have one study blood sample drawn (80 mL bloodvolume) at the same time
that standard care bloodwork is performed. Participants will receive
questionnaires at the same time points of the blood draw.
The benefit for the psoriasis patient is an early diagnosis of PsA. No other
benefits is expected from participation.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Patients with psoriasis, psoriatic arthritis, ankylosing spondylitis (AS), inflammatory bowel disease associated arthritis, reactive arthritis, or undifferentiated spondyloarthritis.
Exclusion criteria
-age 17 years or younger
- age 76 years or older
-The patient has an alternative inflammatory rheumatological diagnosis (e.g. rheumatoid arthritis, gout, pseudogout).
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 | NL46903.041.13 |