'MUCosal Origin of Serum Autoantibodies in rheumatoid arthritis'

Recruiting

Conditions: RA
Rheumatoid artritis
10003816

Registration Number: NL-OMON48311

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 260

Inclusion Criteria

- Age 18 years or older
- Ability to understand the patient information form and ability to provide
written informed consent
- Written informed consent

For patients:
- a definite diagnosis of rheumatoid arthritis based on the ACR/EULAR 2010
criteria for RA

For healthy controls:
- No previous prolonged and/or current symptoms of inflammatory arthritis

Exclusion Criteria

- Individuals who fail to meet the inclusion criteria
- Individuals for whom relevant safety issues apply (for example, dyspnoea or
severe anaemia) that preclude the provision of sputum, saliva, peripheral blood
or feces
- Individuals who are currently suffering from upper airway infections,
influenza or other contagious (lung)diseases
- Dental treatment within the previous month
- The presence of oral ulcers
- Individuals with known inflammatory bowel disease

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The detection of several RA associated antibodies and their distinct antibody<br /><br>features in feces, saliva and sputum of patients. This will be compared to the<br /><br>autoantibody profile in serum. Among the distinct antibody features that will<br /><br>be explored are isotype usage, fine-specificity, glycosylation of Fc- and<br /><br>Fab-region, avidity and affinity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The presence and characteristics of other biomarkers reflecting the mucosal<br /><br>immune response in feces, saliva and sputum of patients with RA and healthy<br /><br>controls. These biomarkers include: the presence of (anti-)inflammatory<br /><br>cytokines and chemokines and the structure and origin of antigens. Furthermore,<br /><br>collaboration with other centers may allow the investigation of the microbiome<br /><br>composition in the future.</p><br>