Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
NCT ID: NCT02693340
Last Updated: 2016-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2016-02-29
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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sampling
• Sampling period(s):
* Blood: W0, W6, W14, W30 and W52 and relapse.
* Biopsies and fecal: W0, W14 and M52 and relapse.
Eligibility Criteria
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Inclusion Criteria
* Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations).
* Active disease as defined by clinical biological and/or morphological assessment.
* Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease.
* Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.
Exclusion Criteria
* Following Situations
* Persons unable to understand, read and / or sign an informed consent
* Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
* Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
* No affiliation to a social security scheme, a universal medical coverage or any similar plan.
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Matthieu Allez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Gastroenterology department
Paris, Paris, France
Countries
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Central Contacts
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Facility Contacts
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References
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Veyssiere M, Hammoudi N, Le Bourhis L, Hassid D, Bonnet J, Tran Minh ML, Baudry C, Gornet JM, Chardiny V, Seksik P, Nancey S, Carbonnel F, Treton X, Wils P, Buisson A, Boureille A, Hebuterne X, Serrero M, Fumery M, Louis E, Blanc P, Peyrin-Biroulet L, Bezault M, Soumelis V, Allez M. Blood proteomic signatures associated with disease activity in Inflammatory Bowel Diseases. J Crohns Colitis. 2025 Sep 8:jjaf162. doi: 10.1093/ecco-jcc/jjaf162. Online ahead of print.
Other Identifiers
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P150702
Identifier Type: -
Identifier Source: org_study_id
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