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

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ClinicalTrials.gov Identifier: NCT02693340
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Biological: sampling

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
Study Start Date : February 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Intervention Details:
  • Biological: sampling

    • Sampling period(s):

    • Blood: W0, W6, W14, W30 and W52 and relapse.
    • Biopsies and fecal: W0, W14 and M52 and relapse.


Primary Outcome Measures :
  1. Response to biological treatments [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Microbiota variation [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA

• Sampling period(s):

  • Blood: W0, W6, W14, W30 and W52 and relapse.
  • Biopsies and fecal: W0, W14 and M52 and relapse.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693340


Contacts
Contact: Matthieu Allez, MDPhD +33 1 42 49 95 97 matthieu.allez@aphp.fr

Locations
France
Gastroenterology department Recruiting
Paris, France, 75010
Contact: Matthieu Allez, MDPhD       matthieu.allez@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Matthieu Allez, MD PhD APHP

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02693340     History of Changes
Other Study ID Numbers: P150702
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis