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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2022 |
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Main ID: |
NCT03712826 |
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Date of registration:
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16/08/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease |
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Date of first enrolment:
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July 24, 2022 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03712826 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Gilles Boschetti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Ustekinumab
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Drug: Anti-TNF Drug
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Primary Outcome(s)
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Immunological profile
[Time Frame: Week 14]
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Secondary Outcome(s)
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Dosage of inflammatory markers
[Time Frame: week 14]
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Mass cytometry dosage of immunological markers week 0-week 14
[Time Frame: Week 14]
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Clinical Remission at week 14
[Time Frame: Week 14]
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Secondary ID(s)
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69HCL16_0811
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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