Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases

ConditionsAutoinflammatory Disease Autoimmune Diseases Inflammation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity Hospital, Ghent

About this trial

A multi-centre, prospective study to study cytokine profiles and other potential disease-specific biomarkers in patients with presumed or confirmed diseases of systemic inflammation

The goal of this prospective, observational study is to describe the longitudinal evolution of blood cytokine profiles in patients with presumed or confirmed diseases of systemic inflammation

The main questions it aims to answer are:

* What are the differences and similarities in blood cytokines between different patients and groups presenting symptoms of systemic inflammatory conditions? * How is the cytokine profile of individual patients evolving over time and what is the effect of different therapeutics? * Is cytokine profiling a valuable tool to diagnose and follow-up on patients with systemic inflammatory conditions?

Participants will be asked to give an additional blood volume for research purposes when blood sampling is performed for routine clinical purposes. A subset of patients (those initiated on biologicals) will also be asked to complete questionnaires.

Researchers will compare the blood cytokines profiles between the different groups of systemic inflammatory conditions and with healthy individuals.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Child or adult

Written informed consent

Autoinflammatory diseases (AID), including among others: systemic onset juvenile idiopathic arthritis (sJIA), familial mediterranean fever (FMF), mevalonate kinase deficiency (Hyper IgD syndrome), TNF receptor-associated periodic syndrome (TRAPS), familial Cold Autoinflammatory Syndrome (CAPS), type 1 interferonopathies,…

Autoimmune diseases (AI), including among others: systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), rheumatoid arthritis (RA),…

Disqualifiers

Confirmed localized infection and/or good response to first-line antibiotic treatment

Confirmed malignancy

Trial design

Design model

Single group

Treatments tested in this trial

cytokine and lipidomic profiling
Diagnostic test
* FEBRIS Cytokine Profile Assay (quantification of inflammatory cytokines) * Serum amyloid A * Biobanking of leftover sample for future analyses and specific immunofunctional assay in selected cases * Lipidomics

Treatment groups

2,500 Participants

are divided into 1 treatment group

Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Measurement of inflammatory cytokines (interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) on serum of patients

On the sera of patients, the FEBRIS Cytokine Profile Assay will be performed. The FEBRIS Cytokine Profile Assay is a multiplex panel of inflammatory cytokines (interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) that will be assessed by Meso Scale Discovery (MSD) technology. The concentration of cytokines will be quantified in pg/ml. Sera will be analyzed upon entry in the study and during follow-up (minimum interval of 3 months between samples). Data analyses (multiple logistic regression) will be performed on the cytokine fingerprints of different patient groups taking clinical control of patients into account (sampling during a flare of inflammation versus sampling during disease remission).

Time frame