Biomedicines and Bacterial Translocation in Spondyloarthritis

NCT05244109 | Unknown

• 1 other identifier: 2021/577
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis

Keywords

bacterial translocation

Outcome Measures

Primary Outcomes (1)

• Difference in serum LPS concentration

  Difference in serum LPS concentration, measured by liquid chromatography-mass spectrometry, between D0 (before anti-TNF or anti-IL 17) and D90

  3 months

Study Arms (3)

NSAIDs

EXPERIMENTAL

Patients responding to any class of NSAIDs and unlikely to initiate biotherapy

Other: Blood sample

Anti-TNF antibody

EXPERIMENTAL

Patients requiring the introduction of biotherapy according to current recommendations and randomized to the anti-TNF treatment arm

Other: Blood sample; Drug: anti-TNF antibody administration

Anti-IL17 antibody

EXPERIMENTAL

Patients requiring the introduction of biotherapy according to current recommendations and randomized to the anti-IL-17 treatment arm

Other: Blood sample; Drug: anti-IL-17 antibody administration

Interventions

Blood sample OTHER

Blood samples (2 times; 21mL per visit)

Anti-IL17 antibody; Anti-TNF antibody; NSAIDs

anti-TNF antibody administration DRUG

Anti-TNF antibody administration, according to current recommendations and randomization results

Anti-TNF antibody

anti-IL-17 antibody administration DRUG

Anti-IL-17 antibody administration, according to current recommendations and randomization results

Anti-IL17 antibody

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• IBD already diagnosed by a gastroenterologist or suspicion of IBD (bloody diarrhea)
• Previous exposure to a biomedical drug (anti TNF or anti IL 17).
• Contraindications for treatment with anti-TNF or anti-IL17 (for all patients)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Frank Verhoeven, MD

CONTACT

+33381668241; fverhoeven@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 17, 2022
• Study Start: February 7, 2022
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)