PICTURE: Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03712826

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Drug: Anti-TNF Drug Drug: Ustekinumab	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anti TNF Crohn patient with antiTNF treatment	Drug: Anti-TNF Drug Crohn patient with antiTNF treatment
Experimental: Ustekinumab Crohn disease with ustekinumab treatment	Drug: Ustekinumab Crohn disease with ustekinumab treatment

Arm

Intervention/Treatment

Experimental: anti TNF

Crohn patient with antiTNF treatment

Drug: Anti-TNF Drug

Crohn patient with antiTNF treatment

Experimental: Ustekinumab

Crohn disease with ustekinumab treatment

Drug: Ustekinumab

Crohn disease with ustekinumab treatment

Outcome Measures

Primary Outcome Measures

Immunological profile [Week 14]
Identify by cytometry of mass a predictive, blood and/or mucous immunological profile, of the answer at week 14 to a biotherapics by anti-TNFa or anti IL-12 / 23 at suffering patients of Crohn disease in relapse

Secondary Outcome Measures

Mass cytometry dosage of immunological markers week 0-week 14 [Week 14]
Measurements of immunological markers by mass cytometry will be performed in the blood at baseline and at week 14 and in the gastrointestinal mucosa (endoscopic biopsies) only at baseline.
Clinical Remission at week 14 [Week 14]
Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at week 14.
Dosage of inflammatory markers [week 14]
Assays for inflammatory blood (CRP) and fecal markers (fecal calprotectin) will be performed to predict the response to anti-TNFα or ustekinumab (anti IL-12/23) at inclusion and at week 14, with conventional methods used routinely.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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