Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

— IBDOT  

Official title:

Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693340
• Other study ID #: P150702
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: June 23, 2016
• Start date: February 2016
• Est. completion date: March 2020

Study information

• Verified date: June 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Matthieu Allez, MDPhD
• Phone: +33 1 42 49 95 97
• Email: matthieu.allez[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• sampling
• Sampling period(s): Blood: W0, W6, W14, W30 and W52 and relapse. Biopsies and fecal: W0, W14 and M52 and relapse.

Locations

Country	Name	City	State
France	Gastroenterology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to biological treatments		12 months	No
Secondary	Microbiota variation		12 months	No