Lupus Erythematosus, SystemicEXIMIOUSNCT07000903
Occupational and Environmental Causes of Autoimmune Diseases
A study testing Exposure and immune profiles in people with Lupus Erythematosus, Systemic and Systemic Sclerosis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The investigators hypothesize that part of the systemic autoimmune diseases (AID) patients might prove to have an occupational or environmental disease which is potentially preventable. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Systemic Sclerosis, Rheumatoid Arthritis
- What is being tested?
- Exposure and immune profiles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically active lupus; systemic sclerosis; rheumatoid arthritis
- At least 18 years old
- Without first line disease-modifying therapy
- Written informed consent must be obtained before any assessment is performed
Who cannot join
- Younger than 18
- Wearers of metal prostheses
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: Occupational and Environmental Causes of Autoimmune Diseases: Clarifying Epidemiology and Improving Detection
The investigators hypothesize that part of the systemic autoimmune diseases (AID) patients might prove to have an occupational or environmental disease which is potentially preventable. The recognition of the occupational or environmental etiology of autoimmune disorders has major implications for patients and society and will generate opportunity for prevention and meaningful clinical intervention. The investigators intend to use the urine/blood exposure measurements to demonstrate the etiological role of environment in patients developing AID patients.
The investigators are mounting an epidemiological study to elucidate the environmental etiology of AID and their effects on the immune profile and disease course. A population-based case-control study will be done with adult patients with newly diagnosed systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis (n=100 per disease).
Read the detailed description
Systemic autoimmune diseases (AID) regroup a broad range of related diseases characterized by self-damaging immune responses. They mainly comprise systemic lupus, systemic sclerosis and rheumatoid arthritis and remain a significant clinical challenge. Rheumatoid arthritis (RA) is a degenerative disease associated with chronic inflammation that ultimately leads to joint damage, deformation and destruction. Systemic lupus erythematosus (SLE) is characterized by tissue injury resulting from immune responses and serological changes. This multifaceted etiology AID is initiated by the loss of tolerance to self-antigens and the accumulation of autoreactive B and T cells that promote autoreactive antibody production, immune complex formation and activated mononuclear cell infiltration in affected tissues. Finally, small vessels-vasculopathology, internal tissue fibrogenesis and thickening skin characterize systematic sclerosis (SSc) patients. These lesions derive from dysregulated immune functions altering connective tissue integrity.
Several risk factors have been pinpointed to explain the triggering of these AID. Scientists have managed to identify the main genetic factors. Susceptibility to AID is strongly associated to MHC class II polymorphisms and adaptive immunity activation (particularly effector T lymphocytes).
Nevertheless, several studies have also emphasized the contribution of environmental factors, which may function as triggers of innate immunity and may contribute to the breakdown of self-tolerance by modifying protein antigens. Cigarette smoking has proven to be a strong risk factor for seropositive RA and SLE. Cigarette smoke leads to post-translational modifications of antigens by citrullination (citrullinated antigens) that induce the production of anticitrullinated protein antibodies (ACPA) and the onset of ACPA-positive RA. Occupational factors may also cause or trigger AID. In a retrospective study conjointly performed by the Cliniques Universitaires Saint-Luc (CUSL) and UZ Leuven, it was concluded that an estimated 50% of male patients suffering from SSc have occupational exposure to silica and solvents. These findings indicate that environmental factors can provide clinically useful information in the management of AID patients.
- Being tested
- Exposure and immune profiles
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and immune profilesOther
The exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit.
| Study group | Role | What they receive |
|---|---|---|
| Exposure and immune profiles | Experimental | The exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit. Receives: Other: Exposure and immune profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposome: quantification of the exposure of patients to environmental agents
exposure to different environmental pollutants is different in cases with systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis.
Measured: Through the entire study, approximately during 30 months
Exposome: quantification of the exposure of patients to agents
exposure to different occupational pollutants is different in cases with systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis.
Measured: Through the entire study, approximately during 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start10 May 2022
- Primary completion5 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Verify the added value of environmental exposure and immunophenotyping to establish a possible etiology of AID: the exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Huaux, Pr, Study director, UCLouvain - IREC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000903
- Sponsor's protocol ID
- 2021/21SEP/388
- Acronym
- EXIMIOUS
- Status last verified
- May 2025
- First submitted
- 20 Jun 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational and Environmental Causes of Autoimmune Diseases: Clarifying Epidemiology and Improving Detection
- ClinicalTrials.gov ID
- NCT07000903
- Acronym / sponsor ID
- EXIMIOUS / 2021/21SEP/388
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Jun 2025 (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.
The investigators hypothesize that part of the systemic autoimmune diseases (AID) patients might prove to have an occupational or environmental disease which is potentially preventable. The recognition of the occupational or environmental etiology of autoimmune disorders has major implications for patients and society and will generate opportunity for prevention and meaningful clinical intervention. The investigators intend to use the urine/blood exposure measurements to demonstrate the etiological role of environment in patients developing AID patients.
The investigators are mounting an epidemiological study to elucidate the environmental etiology of AID and their effects on the immune profile and disease course. A population-based case-control study will be done with adult patients with newly diagnosed systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis (n=100 per disease).
Detailed description
Systemic autoimmune diseases (AID) regroup a broad range of related diseases characterized by self-damaging immune responses. They mainly comprise systemic lupus, systemic sclerosis and rheumatoid arthritis and remain a significant clinical challenge. Rheumatoid arthritis (RA) is a degenerative disease associated with chronic inflammation that ultimately leads to joint damage, deformation and destruction. Systemic lupus erythematosus (SLE) is characterized by tissue injury resulting from immune responses and serological changes. This multifaceted etiology AID is initiated by the loss of tolerance to self-antigens and the accumulation of autoreactive B and T cells that promote autoreactive antibody production, immune complex formation and activated mononuclear cell infiltration in affected tissues. Finally, small vessels-vasculopathology, internal tissue fibrogenesis and thickening skin characterize systematic sclerosis (SSc) patients. These lesions derive from dysregulated immune functions altering connective tissue integrity.
Several risk factors have been pinpointed to explain the triggering of these AID. Scientists have managed to identify the main genetic factors. Susceptibility to AID is strongly associated to MHC class II polymorphisms and adaptive immunity activation (particularly effector T lymphocytes).
Nevertheless, several studies have also emphasized the contribution of environmental factors, which may function as triggers of innate immunity and may contribute to the breakdown of self-tolerance by modifying protein antigens. Cigarette smoking has proven to be a strong risk factor for seropositive RA and SLE. Cigarette smoke leads to post-translational modifications of antigens by citrullination (citrullinated antigens) that induce the production of anticitrullinated protein antibodies (ACPA) and the onset of ACPA-positive RA. Occupational factors may also cause or trigger AID. In a retrospective study conjointly performed by the Cliniques Universitaires Saint-Luc (CUSL) and UZ Leuven, it was concluded that an estimated 50% of male patients suffering from SSc have occupational exposure to silica and solvents. These findings indicate that environmental factors can provide clinically useful information in the management of AID patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Verify the added value of environmental exposure and immunophenotyping to establish a possible etiology of AID: the exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit.
| Arm | Type | Receives |
|---|---|---|
| Exposure and immune profiles | Experimental | Other: Exposure and immune profilesThe exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically active lupus; systemic sclerosis; rheumatoid arthritis
- At least 18 years old
- Without first line disease-modifying therapy
- Written informed consent must be obtained before any assessment is performed
Key exclusion criteria (2 listed)
- Younger than 18
- Wearers of metal prostheses
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 |
|---|---|---|
| Exposure and immune profilesThe exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit. | Other | Exposure and immune profiles |
Primary outcome
Exposome: quantification of the exposure of patients to environmental agents
Time frame: Through the entire study, approximately during 30 months
exposure to different environmental pollutants is different in cases with systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis.
Exposome: quantification of the exposure of patients to agents
Time frame: Through the entire study, approximately during 30 months
exposure to different occupational pollutants is different in cases with systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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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. This study is not recruiting at the moment.
François Huaux, Pr study director
UCLouvain - IREC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and immune profiles in people with Lupus Erythematosus, Systemic and Systemic Sclerosis, run by Université Catholique de Louvain at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposome: quantification of the exposure of patients to environmental agents (time frame: Through the entire study, approximately during 30 months). The study lists 2 primary outcomes in all. 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 3 Jun 2025.