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NCT Number: NCT04899154

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

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).

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Marseille

Marseille, France

Location status: Recruiting

Location contact

Caroline CHARPIN, Dr

PRINCIPAL_INVESTIGATOR

Myriam BENNANI

CONTACT

[email protected]

04 13 42 83 51

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 18 Months

Secondary outcomes

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

    Time frame: 18 Months

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study title

MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Acronym: MEDIBIOTE 3

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 24, 2021
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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