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

NCT04899154 | Recruiting DMC

• 1 other identifier: 2018-A03050-55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients

  18 Months

Secondary Outcomes (1)

• Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.

  18 Months

Study Arms (2)

Patients with spondyloarthritis (Spa)

EXPERIMENTAL

Other: stool sampling

Healthy subjects

EXPERIMENTAL

Other: stool sampling

Interventions

stool sampling 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.

Patients with spondyloarthritis (Spa)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

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

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: July 16, 2019
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)