Status:
UNKNOWN
Biomedicines and Bacterial Translocation in Spondyloarthritis
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 t...
Eligibility Criteria
Inclusion
- Axial spondyloarthritis (2009 ASAS criteria)
- NSAID arm: Responding to any class of NSAID and not likely to initiate biotherapy
- anti-TNF/anti-IL-17 arms: Need to introduce a biomedical drug according to current recommendations (objective signs of inflammation, i.e. MRI sacroiliitis or increased CRP, and failure of two NSAIDs of different classes)
Exclusion
- IBD already diagnosed by a gastroenterologist or suspicion of IBD (bloody diarrhea)
- Previous exposure to a biomedical drug (anti TNF or anti IL 17).
- Antibiotic use in the 3 months prior to inclusion
- Contraindications for treatment with anti-TNF or anti-IL17 (for all patients)
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05244109
Start Date
February 7 2022
End Date
May 1 2025
Last Update
June 1 2022
Active Locations (1)
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1
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000