Axial SpondyloarthritisTEARE-BIONCT05244109
Biomedicines and Bacterial Translocation in Spondyloarthritis
A study testing Blood sample, anti-TNF antibody administration and anti-IL-17 antibody administration in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Blood sample, anti-TNF antibody administration and anti-IL-17 antibody administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
Frank Verhoeven, MD
About this study
Official title: Bacterial Translocation in Spondyloarthritis: Evaluation Before and After Starting a Biomedicine.
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.
Read the 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
- Being tested
- Blood sample, anti-TNF antibody administration, anti-IL-17 antibody administration
- Keywords
- bacterial translocation
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood samples (2 times; 21mL per visit)
anti-TNF antibody administrationDrug
Anti-TNF antibody administration, according to current recommendations and randomization results
anti-IL-17 antibody administrationDrug
Anti-IL-17 antibody administration, according to current recommendations and randomization results
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs | Experimental | Patients responding to any class of NSAIDs and unlikely to initiate biotherapy Receives: 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 Receives: 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 Receives: Other: Blood sample; Drug: anti-IL-17 antibody administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start7 Feb 2022
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244109
- Sponsor's protocol ID
- 2021/577
- Acronym
- TEARE-BIO
- Status last verified
- Apr 2022
- First submitted
- 27 Jan 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Translocation in Spondyloarthritis: Evaluation Before and After Starting a Biomedicine.
- ClinicalTrials.gov ID
- NCT05244109
- Acronym / sponsor ID
- TEARE-BIO / 2021/577
- Conditions
- Axial Spondyloarthritis
- Keywords
- bacterial translocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSAIDs | Experimental | Other: Blood samplePatients responding to any class of NSAIDs and unlikely to initiate biotherapy |
| Anti-TNF antibody | Experimental | Other: Blood sample, Drug: anti-TNF antibody administrationPatients requiring the introduction of biotherapy according to current recommendations and randomized to the anti-TNF treatment arm |
| Anti-IL17 antibody | Experimental | Other: Blood sample, Drug: anti-IL-17 antibody administrationPatients requiring the introduction of biotherapy according to current recommendations and randomized to the anti-IL-17 treatment arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood samples (2 times; 21mL per visit) | Other | Anti-IL17 antibody, Anti-TNF antibody, NSAIDs |
| anti-TNF antibody administrationAnti-TNF antibody administration, according to current recommendations and randomization results | Drug | Anti-TNF antibody |
| anti-IL-17 antibody administrationAnti-IL-17 antibody administration, according to current recommendations and randomization results | Drug | Anti-IL17 antibody |
Primary outcome
Difference in serum LPS concentration
Time frame: 3 months
Difference in serum LPS concentration, measured by liquid chromatography-mass spectrometry, between D0 (before anti-TNF or anti-IL 17) and D90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, anti-TNF antibody administration and anti-IL-17 antibody administration in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Verhoeven, MD (+33381668241, fverhoeven@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum LPS concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.