Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Crohn Disease Clinical Trial

— PICTURE  

Official title:

Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03712826
• Other study ID #: 69HCL16_0811
• Status: Withdrawn
• Phase: N/A
• Start date: July 24, 2022
• Est. completion date: July 24, 2022

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-· 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

• 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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Anti-TNF Drug
Crohn patient with antiTNF treatment
• Ustekinumab
Crohn disease with ustekinumab treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 14
Secondary	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.	Week 14
Secondary	Clinical Remission at week 14	Clinical remission will be defined as a reduction in the CDAI score = 150 at week 14.	Week 14
Secondary	Dosage of inflammatory markers	Assays for inflammatory blood (CRP) and fecal markers (fecal calprotectin) will be performed to predict the response to anti-TNFa or ustekinumab (anti IL-12/23) at inclusion and at week 14, with conventional methods used routinely.	week 14