Crohn DiseasePICTURENCT03712826
Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
A study testing Anti-TNF Drug and Ustekinumab in people with Crohn Disease, run by Hospices Civils de Lyon.
Trial summary
Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Anti-TNF Drug and Ustekinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2022to 24 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient of more than 18 years old
- Patient presenting a MC before diagnosed according to the usual criteria
- Patient in relapse (score CDAI > 150) for at least 1 month
- requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
- Patient compatible with the realization of endoscopic digestive biopsies
- Patient having signed a consent of participation
Who cannot join
- -· patient with Crohn disease with a CDAI score < 150 ·
- contraindication to anti-TNF and\or ustekinumab ·
- contraindication to the realization of an iléocoloscopie
- ·- Patient taking anti-inflammatory drugs or antibiotics ·
- Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
- Patient having a exclusive perianal disease or having
Show all 12Show fewer
- pregnant Women ·
- Patients having been the object of a vast intestinal resection ·
- Patient with an ileostomy or a colostomy ·
- No consent of the patient ·
- patient under legal protection ·
- Subject participating in another research which need a period of exclusion
About this study
Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.
Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.
- Conditions
- Crohn Disease
- Being tested
- Anti-TNF Drug, Ustekinumab
- Keywords
- Crohn, immunological profile, ustekinumab, anti-TNF
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF DrugDrug
Crohn patient with antiTNF treatment
UstekinumabDrug
Crohn disease with ustekinumab treatment
| Study group | Role | What they receive |
|---|---|---|
| anti TNF | Experimental | Crohn patient with antiTNF treatment Receives: Drug: Anti-TNF Drug |
| Ustekinumab | Experimental | Crohn disease with ustekinumab treatment Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological profile
Identify by cytometry of mass a predictive, blood and/or mucous immunological profile, of the answer at week 14 to a biotherapics by anti-TNFa or anti IL-12 / 23 at suffering patients of Crohn disease in relapse
Measured: Week 14
Secondary outcomes (3)
Mass cytometry dosage of immunological markers week 0-week 14
Measurements of immunological markers by mass cytometry will be performed in the blood at baseline and at week 14 and in the gastrointestinal mucosa (endoscopic biopsies) only at baseline.
Measured: Week 14
Clinical Remission at week 14
Clinical remission will be defined as a reduction in the CDAI score ≤ 150 at week 14.
Measured: Week 14
Dosage of inflammatory markers
Assays for inflammatory blood (CRP) and fecal markers (fecal calprotectin) will be performed to predict the response to anti-TNFα or ustekinumab (anti IL-12/23) at inclusion and at week 14, with conventional methods used routinely.
Measured: week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start24 Jul 2022
- Primary completion24 Jul 2022
- Study completion24 Jul 2022
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Boschetti, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712826
- Sponsor's protocol ID
- 69HCL16_0811
- Acronym
- PICTURE
- Status last verified
- Sep 2022
- First submitted
- 16 Aug 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT03712826
- Acronym / sponsor ID
- PICTURE / 69HCL16_0811
- Conditions
- Crohn Disease
- Keywords
- Crohn, immunological profile, ustekinumab, anti-TNF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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.
Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.
Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti TNF | Experimental | Drug: Anti-TNF DrugCrohn patient with antiTNF treatment |
| Ustekinumab | Experimental | Drug: UstekinumabCrohn disease with ustekinumab treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of more than 18 years old
- Patient presenting a MC before diagnosed according to the usual criteria
- Patient in relapse (score CDAI > 150) for at least 1 month
- requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
- Patient compatible with the realization of endoscopic digestive biopsies
Key exclusion criteria (12 listed)
- -· patient with Crohn disease with a CDAI score < 150 ·
- contraindication to anti-TNF and\or ustekinumab ·
- contraindication to the realization of an iléocoloscopie
- ·- Patient taking anti-inflammatory drugs or antibiotics ·
- Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
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 |
|---|---|---|
| Anti-TNF DrugCrohn patient with antiTNF treatment | Drug | anti TNF |
| UstekinumabCrohn disease with ustekinumab treatment | Drug | Ustekinumab |
Primary outcome
Immunological profile
Time frame: Week 14
Identify by cytometry of mass a predictive, blood and/or mucous immunological profile, of the answer at week 14 to a biotherapics by anti-TNFa or anti IL-12 / 23 at suffering patients of Crohn disease in relapse
3 secondary outcomes
Mass cytometry dosage of immunological markers week 0-week 14
Time frame: Week 14
Clinical Remission at week 14
Time frame: Week 14
Dosage of inflammatory markers
Time frame: week 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
Gilles Boschetti, MD principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A study testing Anti-TNF Drug and Ustekinumab in people with Crohn Disease, run by Hospices Civils de Lyon.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological profile (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2022.