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

NCT ID: NCT03712826

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-24
• Study Completion Date: 2022-07-24

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

anti TNF

Crohn patient with antiTNF treatment

Group Type: EXPERIMENTAL

Anti-TNF Drug

Intervention Type: DRUG

Crohn patient with antiTNF treatment

Ustekinumab

Crohn disease with ustekinumab treatment

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Crohn disease with ustekinumab treatment

Interventions

Anti-TNF Drug

Crohn patient with antiTNF treatment

Intervention Type: DRUG

Ustekinumab

Crohn disease with ustekinumab treatment

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Boschetti, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Other Identifiers

69HCL16_0811

Identifier Type: -

Identifier Source: org_study_id