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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)

Primary Purpose

Crohn Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anti-TNF Drug
Ustekinumab
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring Crohn, immunological profile, ustekinumab, anti-TNF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    anti TNF

    Ustekinumab

    Arm Description

    Crohn patient with antiTNF treatment

    Crohn disease with ustekinumab treatment

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    Clinical Remission at week 14
    Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at 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.

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    September 28, 2022
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03712826
    Brief Title
    Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
    Acronym
    PICTURE
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No inclusion
    Study Start Date
    July 24, 2022 (Actual)
    Primary Completion Date
    July 24, 2022 (Actual)
    Study Completion Date
    July 24, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease
    Keywords
    Crohn, immunological profile, ustekinumab, anti-TNF

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    anti TNF
    Arm Type
    Experimental
    Arm Description
    Crohn patient with antiTNF treatment
    Arm Title
    Ustekinumab
    Arm Type
    Experimental
    Arm Description
    Crohn disease with ustekinumab treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Anti-TNF Drug
    Intervention Description
    Crohn patient with antiTNF treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Ustekinumab
    Intervention Description
    Crohn disease with ustekinumab treatment
    Primary Outcome Measure Information:
    Title
    Immunological profile
    Description
    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
    Time Frame
    Week 14
    Secondary Outcome Measure Information:
    Title
    Mass cytometry dosage of immunological markers week 0-week 14
    Description
    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.
    Time Frame
    Week 14
    Title
    Clinical Remission at week 14
    Description
    Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at week 14.
    Time Frame
    Week 14
    Title
    Dosage of inflammatory markers
    Description
    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.
    Time Frame
    week 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gilles Boschetti, MD
    Organizational Affiliation
    Hospices Civils de Lyon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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