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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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ClinicalTrials.gov Identifier: NCT03712826
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : March 11, 2019
Sponsor:
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 : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03712826


Contacts
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Contact: Gilles Boschetti, MD 04.78.86.03.02 ext +33 gilles.boschetti@chu-lyon.fr
Contact: Anne-Laure Charlois 04.78.86.37.67 ext +33 anne-laure.charlois@chu-lyon.fr

Locations
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France
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Gilles Boschetti, MD    04.78.86.03.02 ext +33    gilles.boschetti@chu-lyon.fr   
Contact: Anne-Laure Charlois    04.78.86.37.67 ext +33    anne-laure.charlois@chu-lyon.fr   
Principal Investigator: Gilles Boschetti, MD         
Sub-Investigator: Stéphane Nancey, MD         
Sub-Investigator: Bernard Flourié, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gilles Boschetti, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03712826     History of Changes
Other Study ID Numbers: 69HCL16_0811
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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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:
Crohn
immunological profile
ustekinumab
anti-TNF

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents