Clinical trial NCT03712826: Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
Official title: Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn
immunological profile
ustekinumab
anti-TNF
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.

Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.


Eligibility criteria: Inclusion Criteria:

* Patient of more than 18 years old
* Patient presenting a MC before diagnosed according to the usual criteria
* Patient in relapse (score CDAI \> 150) for at least 1 month
* requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
* Patient compatible with the realization of endoscopic digestive biopsies
* Patient having signed a consent of participation

Exclusion Criteria:

-· patient with Crohn disease with a CDAI score \< 150 ·

* contraindication to anti-TNF and\\or ustekinumab ·
* contraindication to the realization of an iléocoloscopie

  ·- Patient taking anti-inflammatory drugs or antibiotics ·
* Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
* Patient having a exclusive perianal disease or having
* pregnant Women ·
* Patients having been the object of a vast intestinal resection ·
* Patient with an ileostomy or a colostomy ·
* No consent of the patient ·
* patient under legal protection ·
* Subject participating in another research which need a period of exclusion

Primary outcomes:
measure: Immunological profile
timeFrame: Week 14
Secondary outcomes:
measure: Mass cytometry dosage of immunological markers week 0-week 14
timeFrame: Week 14
measure: Clinical Remission at week 14
timeFrame: Week 14
measure: Dosage of inflammatory markers
timeFrame: week 14
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles Boschetti, MD
role: PRINCIPAL_INVESTIGATOR
References: