Occupational and Environmental Causes of Autoimmune Diseases

NCT07000903 | Completed

• 1 other identifier: 2021/21SEP/388
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Lupus Erythematosus, Systemic; Systemic Sclerosis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through the entire study, approximately during 30 months

Study Arms (1)

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.

Other: Exposure and immune profiles

Interventions

Exposure and immune profiles OTHER

The exposure and immune profiles will be determined in HBM blood and urine samples collected prospectively during the first SOC visit.

Exposure and immune profiles

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Younger than 18
• Wearers of metal prostheses

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• François Huaux, Pr

  UCLouvain - IREC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 3, 2025
• Study Start: May 10, 2022
• Primary Completion: April 5, 2024
• Study Completion: December 31, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

BE (1)