Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT02693340
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24
• Primary Completion: 2018-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to biological treatments	12 months

Secondary Outcome Measures

Name	Time	Method
Microbiota variation	12 months

Trial Locations

Locations (1)

Gastroenterology department; 🇫🇷 Paris, France