Autoinflammatory DiseaseFEBRISNCT05670301
Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
A study testing cytokine and lipidomic profiling in people with Autoinflammatory Disease and Autoimmune Diseases, run by University Hospital, Ghent at 7 sites in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autoinflammatory Disease, Autoimmune Diseases, Inflammation
- What is being tested?
- cytokine and lipidomic profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 7 sitesBelgium
- Study dates
- 28 Sep 2022to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An individual who meets any of the following criteria can be eligible for participation in this study:
- Child or adult
- Written informed consent
- Suspected or confirmed disease with systemic inflammation (acute, chronic and/or recurrent), these include:
- 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),…
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- Hyperinflammatory diseases, including among others: hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), infection-related cytokine storm (e.g. in the setting of COVID-19)
- Other unidentified or not yet identified systemic inflammatory conditions
- Blood sample for diagnostic purposes is planned and possibility to acquire additional blood volume
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Confirmed localized infection and/or good response to first-line antibiotic treatment
- Confirmed malignancy
- Besides the above mentioned patients, volunteers that meet the requirements as a healthy individual are eligible for inclusion as controls.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Belgium7 sites, 5 recruiting
- Recruiting
UZ Antwerpen
Antwerp
Benson Ogunjimi, +32 3 821 32 51, benson@uantwerp.be
Benson Ogunjimi
- Not yet recruiting
ZNA
Antwerp
Benson Ogunjimi, +32 3 821 32 51, benson@uantwerp.be
Benson Ogunjimi
- Recruiting
UZ Brussel
Brussels
Benson Ogunjimi, +32 3 821 32 51, benson@uantwerp.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Filomeen Haerynck, MD, PhD, 093323581, filomeen.haerynck@uzgent.be
Levi Hoste, MD, 093323581, levi.hoste@uzgent.be
- Active, not recruiting
UGent
Ghent
- Recruiting
Jessa Hospital
Hasselt
Jeroen Van der hilst, 011 33 76 50, Jeroen.Vanderhilst@jessazh.be
Jeroen Van der hilst
- Active, not recruiting
UHasselt
Hasselt
About this study
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
Read more
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.
Read the detailed description
FEBRIS is a prospective, observational and multi-centric study involving 5 hospitals in Flanders, Belgium.
In this study, the researchers will us ehe FEBRIS Cytokine Profile Assay, which is a multiplex assay measuring pro- and anti-inflammatory cytokines in the blood of subjects. It has been developed in a retrospective cohort of human patients presenting systemic inflammatory disorders.
With this study, the researchers aim to prospectively validate the use of this assay in a cohort of patients that present signs reminiscent of systemic inflammation, including patients with antoinflammatory conditions, autoimmune disorders, hyperinflammatory syndromes (e.g. hemophagocytic lymphohistiocytosis and macrophage activation syndrome) and systemic infection. In parallel, serum amyloid A will be quantified in all patients. Lipidomics will be performed on patients with sufficient leftover sample. The researchers will integrate the data from these assays with clinical parameters at baseline and during follow-up to correlate markers with the clinical or genetic diagnosis, prognosis and effect of different therapeutics.
Patients fulfilling the inclusion criteria are eligible for longitudinal blood sampling (every 3-6 months) during the study period (maximum of 4 years). Additional clotted blood will only be collected when a blood sample for routine clinical purposes is performed.
In addition, patients initiated on biological therapeutics will be asked to complete questionnaires regarding health-related quality of life to document outcome and improve rational and cost-efficient use of additional investigations and treatment.
- Conditions
- Autoinflammatory Disease, Autoimmune Diseases, Inflammation
- Being tested
- cytokine and lipidomic profiling
- Medical subject headings
- Autoimmune Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine and lipidomic profilingDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cytokine assessment Receives: Diagnostic Test: cytokine and lipidomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: full study period (up to 48 months)
Secondary outcomes (10)
Additional 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 that are initiated on biological treatment
In patients included in the study that are initiated on biopharmaceuticals, additional blood sampling will be carried out before start of treatment and after 3 months of therapy. On this blood the FEBRIS Cytokine Profile Assay (measurement of IL-1 beta, IL-1RA, IL-6, IL-18, TNF alpha, CXCL9 and CXCL10) will be performed. The concentration of cytokines will be quantified in pg/ml.
This data will be used in retrospective analyses with the aim to identify biomarkers or cytokine profiles that separate responders from non-responders.
Measured: full study period (up to 48 months)
Registration of age
At each study visit, the patient's age will be registered through a structured case report form.
Age will be registered in years or in months if the child is younger than 2 years.
Measured: full study period (up to 48 months)
Registration of biological sex
At each study visit, the patient's biological sex will be registered through a structured case report form.
Sex will be registered as female, male or intersex
Measured: full study period (up to 48 months)
Registration of weight
At each study visit, the patient's body weight will be registered in kg.
Measured: full study period (up to 48 months)
Registration of length
At each study visit, the patient's length will be registered in cm.
Measured: full study period (up to 48 months)
Registration of confirmed or presumed inflammatory diseases
At each study visit, the patient's known (clinically or genetically confirmed) or tentative inflammatory disease will be registered. This will be registered through a multiple choice list including autoinflammatory disorders (familial Mediterranean fever, tumor necrosis factor receptor associated periodic syndrome, cryopyrin-associated autoinflammatory syndromes, mevalonate kinase deficiency, systemic onset juvenile idiopathic arthritis, periodic fever adenitis pharyngitis and aphthosis, Aicardi-Gutieres syndrome), autoimmune disorders (systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, oligoarthritic juvenile idiopathic arthritis) or hyperacute inflammatory disease (hemophagocytic lymphohistiocytosis, macrophage activation syndrome, infectious disease related cytokine storm) or other and unspecified inflammatory syndromes.
Measured: full study period (up to 48 months)
Registration of clinical symptoms related to inflammatory diseases
At each study visit, the patient's clinical status will be registered through a multiple-choice list to register the presence or absence of symptoms currently or in the 48 hours before blood sampling. Symptoms include fever, hepatomegaly, splenomegaly, myalgia, arthralgia, exanthema, pharyngitis, oral aphthosis, lymphadenopathy, abdominal pain, thoracic pain, enthesitis.
Measured: full study period (up to 48 months)
Registration of current therapy
At each study visit, the patient's current medication will be registered through a multiple-choice list to register the use of therapeutics that have an effect on inflammation. These include systemic non-steroidal anti-inflammatory drugs, systemic corticosteroids, colchicine, anakinra, canakinumab, tocilizumab, TNF inhibitors, hydroxychloroquine, mycophenolate, methotrexate, janus kinase (JAK) inhibitors, abatacept.
Measured: full study period (up to 48 months)
Registration of health-related costs
In the subgroup of patients initiated on biopharmaceuticals, health-related costs will be documented.
To document costs, a questionnaire will be used that was drafted specifically for this project, incorporating registration of the number of visits with caregivers, the type and use of medication, the number and duration of hospitalizations, and questions relating to absence from work.
A health economic specialist will aggregate the data from this questionnaire to calculate an annual cost in euros per patient.
This questionnaire will be given to the patients at initiation of biopharmaceutical treatments and every 6 months throughout the study period.
Measured: full study periode (up to 48 months)
Registration of health-related quality of life
In the subgroup of patients initiated on biopharmaceuticals, health-related quality of life (HRQoL) scores will be documented.
To document HRQoL, the translated version of the PEDsQL and short form 36 (SF-36) will be used for children and adults, respectively.
The raw scores of PEDsQL are converted into three scale scores: a total score, a psychosocial health score and a physical health score.
For the SF-36, the item scores are summed into scale scores (weighted sums) and transformed to a 0-100 scale (each question carries equal weight).
This questionnaire will be given to the patients at initiation of biopharmaceutical treatments and every 6 months throughout the study period.
Measured: full study periode (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start28 Sep 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoinflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Ziekenhuis Netwerk Antwerpen (ZNA), Universitair Ziekenhuis Brussel, Jessa Hospital, Hasselt University
- Responsible party
- Sponsor
- Investigators
- Filomeen Haerynck, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670301
- Sponsor's protocol ID
- BC-11141
- Acronym
- FEBRIS
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: raw and anonymized patient clinical and experimental data
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
- ClinicalTrials.gov ID
- NCT05670301
- Acronym / sponsor ID
- FEBRIS / BC-11141
- Conditions
- Autoinflammatory Disease, Autoimmune Diseases, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Ziekenhuis Netwerk Antwerpen (ZNA), Universitair Ziekenhuis Brussel, Jessa Hospital, Hasselt University
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FEBRIS is a prospective, observational and multi-centric study involving 5 hospitals in Flanders, Belgium.
In this study, the researchers will us ehe FEBRIS Cytokine Profile Assay, which is a multiplex assay measuring pro- and anti-inflammatory cytokines in the blood of subjects. It has been developed in a retrospective cohort of human patients presenting systemic inflammatory disorders.
With this study, the researchers aim to prospectively validate the use of this assay in a cohort of patients that present signs reminiscent of systemic inflammation, including patients with antoinflammatory conditions, autoimmune disorders, hyperinflammatory syndromes (e.g. hemophagocytic lymphohistiocytosis and macrophage activation syndrome) and systemic infection. In parallel, serum amyloid A will be quantified in all patients. Lipidomics will be performed on patients with sufficient leftover sample. The researchers will integrate the data from these assays with clinical parameters at baseline and during follow-up to correlate markers with the clinical or genetic diagnosis, prognosis and effect of different therapeutics.
Patients fulfilling the inclusion criteria are eligible for longitudinal blood sampling (every 3-6 months) during the study period (maximum of 4 years). Additional clotted blood will only be collected when a blood sample for routine clinical purposes is performed.
In addition, patients initiated on biological therapeutics will be asked to complete questionnaires regarding health-related quality of life to document outcome and improve rational and cost-efficient use of additional investigations and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: cytokine and lipidomic profilingCytokine assessment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- An individual who meets any of the following criteria can be eligible for participation in this study:
- Child or adult
- Written informed consent
- Suspected or confirmed disease with systemic inflammation (acute, chronic and/or recurrent), these include:
- Blood sample for diagnostic purposes is planned and possibility to acquire additional blood volume
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Confirmed localized infection and/or good response to first-line antibiotic treatment
- Confirmed malignancy
- Besides the above mentioned patients, volunteers that meet the requirements as a healthy individual are eligible for inclusion as controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytokine and lipidomic profiling* 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 | Diagnostic test | Intervention |
Primary outcome
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
Time frame: full study period (up to 48 months)
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).
10 secondary outcomes
Additional 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 that are initiated on biological treatment
Time frame: full study period (up to 48 months)
Registration of age
Time frame: full study period (up to 48 months)
Registration of biological sex
Time frame: full study period (up to 48 months)
Registration of weight
Time frame: full study period (up to 48 months)
Registration of length
Time frame: full study period (up to 48 months)
Registration of confirmed or presumed inflammatory diseases
Time frame: full study period (up to 48 months)
Registration of clinical symptoms related to inflammatory diseases
Time frame: full study period (up to 48 months)
Registration of current therapy
Time frame: full study period (up to 48 months)
Registration of health-related costs
Time frame: full study periode (up to 48 months)
Registration of health-related quality of life
Time frame: full study periode (up to 48 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. raw and anonymized patient clinical and experimental data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filomeen Haerynck principal investigator
University Ghent
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytokine and lipidomic profiling in people with Autoinflammatory Disease and Autoimmune Diseases, run by University Hospital, Ghent at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filomeen Haerynck (+32 9 332 35 81, filomeen.haerynck@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: full study period (up to 48 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.