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Withdrawn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
About this trial
This is an interventional prevention trial for Crohn Disease focused on measuring Crohn, immunological profile, ustekinumab, anti-TNF
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
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
NCT ID
NCT03712826
First Posted
August 16, 2018
Last Updated
September 28, 2022
Sponsor
Hospices Civils de Lyon
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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