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

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.

Study Overview

• Status: Withdrawn
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Anti-TNF Drug; Drug: Ustekinumab

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological profile	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	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass cytometry dosage of immunological markers week 0-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.	Week 14
Clinical Remission at week 14	Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at week 14.	Week 14
Dosage of inflammatory markers	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.	week 14

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gilles Boschetti, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2022
• Primary Completion (Actual): July 24, 2022
• Study Completion (Actual): July 24, 2022

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: anti-TNF; Crohn; ustekinumab; immunological profile
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: 69HCL16_0811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No