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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03712826
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : July 27, 2021
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

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

Primary Outcome Measures :
  1. Immunological profile [ Time Frame: 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 :
  1. Mass cytometry dosage of immunological markers week 0-week 14 [ Time Frame: 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.

  2. Clinical Remission at week 14 [ Time Frame: Week 14 ]
    Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at week 14.

  3. Dosage of inflammatory markers [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03712826

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Contact: Gilles Boschetti, MD ext +33
Contact: Anne-Laure Charlois ext +33

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Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Contact: Gilles Boschetti, MD ext +33   
Contact: Anne-Laure Charlois ext +33   
Principal Investigator: Gilles Boschetti, MD         
Sub-Investigator: Stéphane Nancey, MD         
Sub-Investigator: Bernard Flourié, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Gilles Boschetti, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon Identifier: NCT03712826    
Other Study ID Numbers: 69HCL16_0811
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
immunological profile
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents