Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease (IBDOT)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Inflammatory Bowel Disease

Treatments: Biological: sampling

Study type: Observational

Funder types: Other

Identifiers

NCT02693340

P150702

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.