Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

NCT ID: NCT02693340

Last Updated: 2016-06-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-03-31

Brief Summary

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This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 or more.
* 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

* Patients under guardianship / curators
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Allez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Gastroenterology department

Paris, Paris, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Matthieu Allez, MDPhD

Role: CONTACT

+33 1 42 49 95 97

Facility Contacts

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Matthieu Allez, MDPhD

Role: primary

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.

Reference Type DERIVED
PMID: 40920365 (View on PubMed)

Other Identifiers

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P150702

Identifier Type: -

Identifier Source: org_study_id

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