Inflammatory Bowel DiseaseIBDOTNCT02693340
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- sampling
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gastroenterology department
Paris, Paris, 75010
Matthieu Allez, MDPhD, matthieu.allez@aphp.fr
About this study
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).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- sampling
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samplingBiological
- Sampling period(s):
- Blood: W0, W6, W14, W30 and W52 and relapse.
- Biopsies and fecal: W0, W14 and M52 and relapse.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to biological treatments
Measured: 12 months
Secondary outcomes (1)
Microbiota variation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Allez, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693340
- Sponsor's protocol ID
- P150702
- Acronym
- IBDOT
- Status last verified
- Jun 2016
- First submitted
- 23 Feb 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40920365
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02693340
- Acronym / sponsor ID
- IBDOT / P150702
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients under guardianship / curators
- Following Situations
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling• Sampling period(s): * Blood: W0, W6, W14, W30 and W52 and relapse. * Biopsies and fecal: W0, W14 and M52 and relapse. | Biological | – |
Primary outcome
Response to biological treatments
Time frame: 12 months
1 secondary outcome
Microbiota variation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 40920365Veyssiere 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.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Allez, MD PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Allez, MDPhD (+33 1 42 49 95 97, matthieu.allez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to biological treatments (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.