NCT02693340

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

February 23, 2016

Last Update Submit

June 23, 2016

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Response to biological treatments

    12 months

Secondary Outcomes (1)

  • Microbiota variation

    12 months

Interventions

samplingBIOLOGICAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology department

Paris, Paris, 75010, France

RECRUITING

Related Publications (1)

  • 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 28;19(9):jjaf162. doi: 10.1093/ecco-jcc/jjaf162.

    PMID: 40920365DERIVED

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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Matthieu Allez, MD PhD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu Allez, MDPhD

CONTACT

+33 1 42 49 95 97matthieu.allez@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2020

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

FR(1)