Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

NCT ID: NCT04899154

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2026-05-15

Brief Summary

Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

Conditions

Spondyloarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with spondyloarthritis (Spa)

Group Type: EXPERIMENTAL

stool sampling

Intervention Type: OTHER

Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.

Healthy subjects

Group Type: EXPERIMENTAL

stool sampling

Intervention Type: OTHER

Participants will provide one stool sample at inclusion

Interventions

stool sampling

Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.

Intervention Type: OTHER

stool sampling

Participants will provide one stool sample at inclusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For patient with spondyloarthritis:

• Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.
• Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)
• patient not previously treated with biotherapy
• Aged ≥ 18 years
• Having given free and informed written consent
• Being affiliated to the center national security system social

For control Subject:

• Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease.
• Aged ≥ 18 years
• Having given free and informed written consent
• Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria

• Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.
• Association with another chronic pathology

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Européen Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Myriam BENNANI

Role: primary

m.bennani@hopital-europeen.fr

04 13 42 83 51

Other Identifiers

2018-A03050-55

Identifier Type: -

Identifier Source: org_study_id