The goal of this study is to identify and validate recently discovered and novel biomarkers of pathophysiology, diagnosis, classification, disease activity, prognosis, treatment susceptibility, and treatment efficacy in IMIDs.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify immunological alterations in the PB and SF of patients with various
forms of established or early forms of immune-mediated inflammatory diseases
and to correlate these alterations with diagnosis, disease stage, prognosis,
and treatment response and compare this to healthy controls. We thereby aim to
identify and validate novel biomarkers that can be used for personalized
medicine in IMIDs
Secondary outcome
n.a.
Background summary
Despite the impact of immune-mediated inflammatory diseases, the cellular and
molecular pathways (the immunotype) driving these diseases remain largely
unknown. Accordingly, it remains difficult to correctly diagnose and classify
these diseases at an early stage and to predict the persistence and evolution
of the disease in an individual patient. Moreover, despite the development of a
variety of novel and powerful drugs (including the so-called biologicals), the
patient's response to treatment remains heterogeneous and difficult to predict.
Therefore, there is a clear need for the identification and validation of
cellular and molecular biomarkers which directly reflect the immunotype of a
given disease and can provide useful clinical information for diagnosis,
classification, prognosis and treatment, as well as the development of new
(preventive) therapeutic strategies.
Study objective
The goal of this study is to identify and validate recently discovered and
novel biomarkers of pathophysiology, diagnosis, classification, disease
activity, prognosis, treatment susceptibility, and treatment efficacy in IMIDs.
Study design
A monocenter study will be started in patients with IMIDs. Patients will be
recruited from the outpatient clinic in AMC. It concerns a single visit study.
Demographic data and clinical data regarding classification of diagnosis,
medication use and disease activity will be collected. Once the patient has
given informed consent, the synovial fluid (if obtained by the treating
physician in case of standard care) will be collected and blood will be drawn
for the study and if necessary for care.
Study burden and risks
Blood drawing has no additional risks except for development of a hematoma.
(Synovial fluid aspiration is performed by the treating physician as a regular
treatment or diagnostic tool for arthritis, therefore no additional risks are
involved by participating in this study.)
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- patients with clinically suspected arthralgia or a diagnosis of an
immune-mediated inflammatory disease
- patients must be 18 years or older
Exclusion criteria
- patients unable to give informed consent
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 | NL65076.018.18 |