AYLo - AutoimmunitY and Loss of y (AYLo)

Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases

The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.

Through the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.

A further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.

Additionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.

By integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.

Study Overview

• Status: Recruiting
• Conditions: COPD; Sarcoidosis; Idiopathic Inflammatory Myopathies; Rheumatoid Arthritis (RA); Connective Tissue Disease; Interstitial Lung Disease (ILD); Polymyalgia Rheumatica (PMR); Giant Cell Arteritis (GCA); Psoriatic Arthritis (PsA); Asthma Bronchiale; Interstitial Lung Disease Due to Systemic Disease (Disorder); IgG4-Related Diseases; ANCA Associated Vasculitis (AAV)
• Intervention / Treatment: Diagnostic test: Single nucleotide polymorphisms (SNP); Diagnostic test: 3'mRNA sequencing; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Diagnostic test: Flow Cytometry; Diagnostic test: Laboratory assessment; Diagnostic test: Assessment of Pulmonary Involvement

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Simon Michael Petzinna, MD; Phone Number: 0049 151 382 337 07; Email: Simon_Michael.Petzinna@ukbonn.de
• Study Contact Backup: Name: Valentin Sebastian Schäfer, MD; Phone Number: 0049 228 287 17000; Email: valentin.schaefer@ukbonn.de

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • Department of rheumatology
      • Contact: Valentin Sebastian Schäfer, MD; Phone Number: 0049 228 287 17000; Email: valentin.schaefer@ukbonn.de
      • Principal Investigator: Valentin Sebastian Schäfer, MD
      • Sub-Investigator: Simon Michael Petzinna, MD
      • Sub-Investigator: Raul Nicolas Jamin, MD
      • Sub-Investigator: Sebastian Zimmer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population includes male participants aged 50 years or older, divided into two groups: individuals with specific medical conditions (cases) and healthy controls.

1. Participants must have a diagnosis confirmed by the treating physician of one or more of the following conditions:

   Arthritis (RA, PsA), CTD (e.g., systemic lupus erythematosus [SLE], systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis ( eosinophilic granulomatosis with polyangiitis [eGPA], granulomatosis with polyangiitis [GPA], microscopic polyangiitis [MPA], IgG4-related disease, GCA + PMR), sarcoidosis, COPD, ILD, asthma bronchial

2. Healthy Controls: Healthy male participants aged 50 years or older without any of the following conditions:

   Autoimmune or rheumatological diseases Pulmonary preconditions

3. Exclusion Criteria:

For both groups, females and individuals younger than 50 years are excluded.

Description

Inclusion Criteria:

• Male
• > 50 years
• Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.

Exclusion Criteria:

• Female
• < 50 years

Inclusion Criteria (Healthy controls):

• Male
• > 50 years

Exclusion Criteria (Healthy controls):

• Female
• < 50 years
• autoimmune, rheumatological diease
• pulmonary precondition

Study Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Giant Cell Arteritis (GCA); Patients with GCA (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry
Polymyalgia Rheumatica (PMR); Patients with PMR (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry
ANCA Associated Vasculitis (AAV); Patients with AAV (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
IgG4 Related Diseases; Patients with IgG4 Related Diseases (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry
Idiopathic Inflammatory Myopathies (IIM); Patients with IIM (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Rheumatoid Arthritis (RA); Patients with RA (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Psoriatic Arthritis (PsA); Patients with PsA (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Connective Tissue Diseases (CTD); Patients with CTD (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Sarcoidosis; Patients with sarcoidosis (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Interstitial Lung Diseases (ILD); Patients with ILD (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Chronic Obstructive Pulmonary Disease (COPD); Patients with COPD (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Asthma Bronchiale; Patients with asthma bronchiale (cross sectional, newly diagnosed with follow-up after twelve months).	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.
Healthy Control Group; Age-/ gender matched healthy controls	Diagnostic test: Single nucleotide polymorphisms (SNP); Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.; Diagnostic test: 3'mRNA sequencing; 3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.; Diagnostic test: Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array; Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..; Diagnostic test: Flow Cytometry; Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.; Diagnostic test: Laboratory assessment; Serum Chemistry; Diagnostic test: Assessment of Pulmonary Involvement; Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of the fraction of hematopoietic cells exhibiting mLOY.	Detection and quantification of the fraction of hematopoietic cells exhibiting mLOY in peripheral blood using SNP. Unit of Measure: Percentage (%).	Cross sectional. Newly diagnosed patients: At baseline and 12 months after diagnosis).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Immune Cell Phenotype	Identification and quantification of immune cell subtypes, using flow cytometry. Unit of Measure: Changes in levels (percentages).	Cross sectional. Newly diagnosed patients: At baseline and 12 months after diagnosis
Changes in Cytokine Profiles	Identification and quantification of cytokines using 3'-mRNA transcriptome analysis and ELISA/ Legendplex. Unit of Measure: Changes in levels (pg/mL)	Cross sectional. Newly diagnosed patients: At baseline and 12 months after diagnosis
Number of Participants with Detected Pulmonary Involvement	Detection of structural anomalies in the lung in clinical routine assessment using lung ultrasound, computed tomography, chest radiography and whole-body plethysmography. Unit of Measure: Number of participants.	Cross sectional. Newly diagnosed patients: At baseline and 12 months after diagnosis

Collaborators and Investigators

• Sponsor: University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; Rheumatoid Arthritis; Giant Cell Arteritis; Autoimmune Diseases; Vasculitis; Sarcoidosis; Idiopathic Inflammatory Myopathies; Interstitial Lung Disease; Polymyalgia Rheumatica; Connective Tissue Disease; ANCA Associated Vasculitis; Large Vessel Vasculitis; IgG4-Related Diseases
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neuromuscular Diseases; Joint Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Hypersensitivity; Autoimmune Diseases of the Nervous System; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Skin Diseases, Vascular; Spondylarthritis; Spondylitis; Psoriasis; Hypersensitivity, Delayed; Vasculitis, Central Nervous System; Systemic Vasculitis; Immunoglobulin G4-Related Disease; Arthritis; Lung Diseases; Disease; Lung Diseases, Interstitial; Muscular Diseases; Arthritis, Rheumatoid; Arthritis, Psoriatic; Sarcoidosis; Myositis; Polymyalgia Rheumatica; Giant Cell Arteritis; Vasculitis; Arteritis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Connective Tissue Diseases
• Other Study ID Numbers: 2024-471-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available upon reasonable request from the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No