De rol van de slijmvliezen bij het ontstaan van auto-antistoffen in reumatoïde artritis

Suspended

Conditions: Rheumatoid arthritis

Registration Number: NL-OMON23860

Lead Sponsor: o direct sponsoring of this trail

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

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

Additional exclusion criteria for sputum donation:
- Eye surgery within the past 6 weeks
- Chest trauma within the past 6 weeks
- Exacerbation of chronic obstructive lung disease

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study parameter investigated will be the detection of several RA associated anti-modified protein antibodies (AMPA) and their specific characteristics in feces, saliva and sputum of patients and healthy controls. This will be compared to the autoantibody profile in serum for each subject. Among the distinct antibody features that will be explored are isotype usage, fine-specificity, glycosylation of Fc-and Fab-region, avidity and affinity.

Secondary Outcome Measures

Name	Time	Method
The presence and characteristics of other biomarkers reflecting the mucosal immune response in feces, saliva and sputum of patients with RA and healthy controls will be assessed. These biomarkers include the presence of (anti-) inflammatory cytokines and chemokines and the structure and origin of post-translationally modified antigens as determined by mass spectrometry. In the future we also might investigate microbiome composition in collaboration with other centres.