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'MUCosal Origin of Serum Autoantibodies in rheumatoid arthritis'

'MUCosal Origin of Serum Autoantibodies in rheumatoid arthritis' - MUCOSA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48311
Enrollment
260
Registered
2020-01-13
Start date
2020-07-22
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA Rheumatoid artritis

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)