NCT05244109

Biomedicines and Bacterial Translocation in Spondyloarthritis

Bacterial Translocation in Spondyloarthritis: Evaluation Before and After Starting a Biomedicine.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to evaluate the effect of anti-TNF and anti-IL17 biotherapies on bacterial translocation in patients with NSAID-resistant axial spondyloarthritis.

Detailed description

Axial spondyloarthritis is a common inflammatory rheumatic disease and its management is based on the use of NSAIDs and biotherapies (anti-TNF and anti-IL17 antibodies). Its pathophysiology involves the digestive mucosa. The colon of patients with spondyloarthritis is the site of asymptomatic inflammation. This inflammation results from dysbiosis, which is responsible for activation of innate immunity linked to bacterial translocation phenomena. Dendritic cells are then activated and the immune response is polarized towards the IL23/Th17 axis. This translocation is secondary to an increase in colonic permeability. The increase in digestive permeability allows translocation of bacteria or bacterial fragments, primarily lipopolysaccharide (LPS). Some proinflammatory cytokines (TNF, IFNγ, and IL23) cause an increase in digestive permeability. IL17 produced in the digestive mucosa has two different effects. Indeed, two types of colonic T cells produce IL17: regulatory T Helpers 17 producing IL10 and IL17 and inflammatory T Helpers 17 producing IL17 and IFNγ. The investigators hypothesize that biotherapies decrease bacterial translocation. They suspect a lesser effect of anti-IL17 compared to anti-TNF because of the potential inhibition of Treg17 lymphocytes.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
OTHER	Blood sample	Blood samples (2 times; 21mL per visit)
DRUG	anti-TNF antibody administration	Anti-TNF antibody administration, according to current recommendations and randomization results
DRUG	anti-IL-17 antibody administration	Anti-IL-17 antibody administration, according to current recommendations and randomization results

Timeline

• Start date: 2022-02-07
• Primary completion: 2025-02-01
• Completion: 2025-05-01
• First posted: 2022-02-17
• Last updated: 2022-06-01

Locations

1 site across 1 country: France