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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
France
Hôpital Européen Marseille
RECRUITING
Marseille
Time Frame
Start Date: 2019-07-16
Estimated Completion Date: 2026-05-15
Participants
Target number of participants: 80
Treatments
Experimental: Patients with spondyloarthritis (Spa)
Experimental: Healthy subjects
Sponsors
Leads: Hôpital Européen Marseille

This content was sourced from clinicaltrials.gov