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

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Civil Hospices of Lyon

Status

Withdrawn

Conditions

Crohn Disease

Treatments

Drug: Anti-TNF Drug
Drug: Ustekinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03712826
69HCL16_0811

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

anti TNF
Experimental group
Description:
Crohn patient with antiTNF treatment
Treatment:
Drug: Anti-TNF Drug
Ustekinumab
Experimental group
Description:
Crohn disease with ustekinumab treatment
Treatment:
Drug: Ustekinumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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